Protocol Index	

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OP RESEARCH PRO00035973 NCT04675333 ARM 1 ZHANG	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Complete physical exam
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Baseline signs and symptoms
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Registration
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	3.5 mL of whole blood will be collected for PK analysis of ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of whole blood (3.5 mL) to detect the presence of antibodies to ALX148 is to be obtained prior to the start of treatment. After Cycle 6, ADA samples will only be collected once every 4 cycles (i.e. Cycle 10, 14, etc.) until EOT. ADA samples are only collected from patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will be collected for analysis of receptor occupancy (4 mL). Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	immunophenotyping (5 mL)- Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	molecular analysis (2.5 mL)- Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Hydration
  	sodium chloride 0.9 % infusion 1,000 mL	Dose: 1,000 mL	Route: intravenous	once @ 500 mL/hr for 1 dose	Start: S					Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Chemotherapy
  	CISplatin (PLATINOL) 100 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 100 mg/m2	Route: intravenous	once over 1 Hours for 1 dose			Offset: 2 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CISPLATIN 1 MG/ML INTRAVENOUS SOLUTION	Medications	100 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes	MANNITOL 25 % INTRAVENOUS SOLUTION	Additives	 	No	Yes			  	CARBOplatin (PARAplatin) in sodium chloride 0.9% 250 mL chemo IVPB	AUC: 5 Use AUC	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 3 Hours	Instructions:	Use minimum serum creatinine 0.7 mg/dL for Carboplatin AUC dosing. HOLD and notify provider if SCr increase by GREATER than or EQUAL to 0.5 mg/dL from baseline or SCr GREATER than 1.4.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CARBOPLATIN 10 MG/ML INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes				Chemotherapy
  	fluorouraciL (ADRUCIL) 1,000 mg/m2 in sodium chloride 0.9% 100 mL chemo infusion - AMBULATORY PUMP	Dose: 1,000 mg/m2	Route: intravenous	once over 96 Hours for 1 dose			Offset: 4 Hours	Instructions:	Nurses to chart as GIVEN on the MAR.  Administer via CADD pump.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	FLUOROURACIL 5 GRAM/100 ML INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	No	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	3.5 mL of whole blood will be collected for PK analysis of ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will be collected for analysis of receptor occupancy (4 mL). Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Days 2,3	Perform every 1 day x2		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --				Day 5	Perform every 1 day x1		Pump Disconnect Appointment Request
  	ONC PUMP DISCONNECT APPOINTMENT REQUEST	Interval: --	Occurrences: --			Discharge Nursing Orders
  	DISCONNECT CONTINUOUS INFUSION PUMP	Interval: --	Occurrences: --	Comments:	Disconnect patient from continuous infusion pump.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Days 8,15	Perform every 7 days x2		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --					
Cycle 2	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	3.5 mL of whole blood will be collected for PK analysis of ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of whole blood (3.5 mL) to detect the presence of antibodies to ALX148 is to be obtained prior to the start of treatment. After Cycle 6, ADA samples will only be collected once every 4 cycles (i.e. Cycle 10, 14, etc.) until EOT. ADA samples are only collected from patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will be collected for analysis of receptor occupancy (4 mL). Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	immunophenotyping (5 mL)- Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	molecular analysis (2.5 mL)- Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Hydration
  	sodium chloride 0.9 % infusion 1,000 mL	Dose: 1,000 mL	Route: intravenous	once @ 500 mL/hr for 1 dose	Start: S					Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Chemotherapy
  	CISplatin (PLATINOL) 100 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 100 mg/m2	Route: intravenous	once over 1 Hours for 1 dose			Offset: 2 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CISPLATIN 1 MG/ML INTRAVENOUS SOLUTION	Medications	100 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes	MANNITOL 25 % INTRAVENOUS SOLUTION	Additives	 	No	Yes			  	CARBOplatin (PARAplatin) in sodium chloride 0.9% 250 mL chemo IVPB	AUC: 5 Use AUC	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 3 Hours	Instructions:	Use minimum serum creatinine 0.7 mg/dL for Carboplatin AUC dosing. HOLD and notify provider if SCr increase by GREATER than or EQUAL to 0.5 mg/dL from baseline or SCr GREATER than 1.4.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CARBOPLATIN 10 MG/ML INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes				Chemotherapy
  	fluorouraciL (ADRUCIL) 1,000 mg/m2 in sodium chloride 0.9% 100 mL chemo infusion - AMBULATORY PUMP	Dose: 1,000 mg/m2	Route: intravenous	once over 96 Hours for 1 dose			Offset: 4 Hours	Instructions:	Nurses to chart as GIVEN on the MAR.  Administer via CADD pump.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	FLUOROURACIL 5 GRAM/100 ML INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	No	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	3.5 mL of whole blood will be collected for PK analysis of ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will be collected for analysis of receptor occupancy (4 mL). Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 5	Perform every 1 day x1		Pump Disconnect Appointment Request
  	ONC PUMP DISCONNECT APPOINTMENT REQUEST	Interval: --	Occurrences: --			Discharge Nursing Orders
  	DISCONNECT CONTINUOUS INFUSION PUMP	Interval: --	Occurrences: --	Comments:	Disconnect patient from continuous infusion pump.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 10	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --					
Cycle 3	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Procedures
  	BIOPSY	Interval: --	Occurrences: --	Comments:	In addition, an on-study fresh biopsy is requested at C3D1 (if in the Investigator's judgment, such biopsy is feasible and can be safely performed). Collection of a sample at progression will also be requested; both the on-study and the end of treatment biopsies are optional. The sample collected at C3D1 can be collected from C3D1 (± 7 days).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	3.5 mL of whole blood will be collected for PK analysis of ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of whole blood (3.5 mL) to detect the presence of antibodies to ALX148 is to be obtained prior to the start of treatment. After Cycle 6, ADA samples will only be collected once every 4 cycles (i.e. Cycle 10, 14, etc.) until EOT. ADA samples are only collected from patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will be collected for analysis of receptor occupancy (4 mL). Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	immunophenotyping (5 mL)- Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	molecular analysis (2.5 mL)- Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Hydration
  	sodium chloride 0.9 % infusion 1,000 mL	Dose: 1,000 mL	Route: intravenous	once @ 500 mL/hr for 1 dose	Start: S					Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Chemotherapy
  	CISplatin (PLATINOL) 100 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 100 mg/m2	Route: intravenous	once over 1 Hours for 1 dose			Offset: 2 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CISPLATIN 1 MG/ML INTRAVENOUS SOLUTION	Medications	100 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes	MANNITOL 25 % INTRAVENOUS SOLUTION	Additives	 	No	Yes			  	CARBOplatin (PARAplatin) in sodium chloride 0.9% 250 mL chemo IVPB	AUC: 5 Use AUC	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 3 Hours	Instructions:	Use minimum serum creatinine 0.7 mg/dL for Carboplatin AUC dosing. HOLD and notify provider if SCr increase by GREATER than or EQUAL to 0.5 mg/dL from baseline or SCr GREATER than 1.4.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CARBOPLATIN 10 MG/ML INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes				Chemotherapy
  	fluorouraciL (ADRUCIL) 1,000 mg/m2 in sodium chloride 0.9% 100 mL chemo infusion - AMBULATORY PUMP	Dose: 1,000 mg/m2	Route: intravenous	once over 96 Hours for 1 dose			Offset: 4 Hours	Instructions:	Nurses to chart as GIVEN on the MAR.  Administer via CADD pump.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	FLUOROURACIL 5 GRAM/100 ML INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	No	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	3.5 mL of whole blood will be collected for PK analysis of ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will be collected for analysis of receptor occupancy (4 mL). Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 2	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --				Day 5	Perform every 1 day x1		Pump Disconnect Appointment Request
  	ONC PUMP DISCONNECT APPOINTMENT REQUEST	Interval: --	Occurrences: --			Discharge Nursing Orders
  	DISCONNECT CONTINUOUS INFUSION PUMP	Interval: --	Occurrences: --	Comments:	Disconnect patient from continuous infusion pump.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 4	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	CT is the preferred modality, but use of MRI is permissible. Order MRI if clinically appropriate. 
The first on-study CT or MRI scans will be performed after 8 weeks (±7 days) from the start of study treatment (C1D1) and will continue every 8 weeks (±7 days) for the first 18 months on study or until disease progression by RECIST v1.1 or death, or until starting a new treatment for the disease under study, or withdrawal of consent.
			Imaging
  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT SOFT TISSUE NECK W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	3.5 mL of whole blood will be collected for PK analysis of ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of whole blood (3.5 mL) to detect the presence of antibodies to ALX148 is to be obtained prior to the start of treatment. After Cycle 6, ADA samples will only be collected once every 4 cycles (i.e. Cycle 10, 14, etc.) until EOT. ADA samples are only collected from patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will be collected for analysis of receptor occupancy (4 mL). Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	immunophenotyping (5 mL)- Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	molecular analysis (2.5 mL)- Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Hydration
  	sodium chloride 0.9 % infusion 1,000 mL	Dose: 1,000 mL	Route: intravenous	once @ 500 mL/hr for 1 dose	Start: S					Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Chemotherapy
  	CISplatin (PLATINOL) 100 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 100 mg/m2	Route: intravenous	once over 1 Hours for 1 dose			Offset: 2 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CISPLATIN 1 MG/ML INTRAVENOUS SOLUTION	Medications	100 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes	MANNITOL 25 % INTRAVENOUS SOLUTION	Additives	 	No	Yes			  	CARBOplatin (PARAplatin) in sodium chloride 0.9% 250 mL chemo IVPB	AUC: 5 Use AUC	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 3 Hours	Instructions:	Use minimum serum creatinine 0.7 mg/dL for Carboplatin AUC dosing. HOLD and notify provider if SCr increase by GREATER than or EQUAL to 0.5 mg/dL from baseline or SCr GREATER than 1.4.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CARBOPLATIN 10 MG/ML INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes				Chemotherapy
  	fluorouraciL (ADRUCIL) 1,000 mg/m2 in sodium chloride 0.9% 100 mL chemo infusion - AMBULATORY PUMP	Dose: 1,000 mg/m2	Route: intravenous	once over 96 Hours for 1 dose			Offset: 4 Hours	Instructions:	Nurses to chart as GIVEN on the MAR.  Administer via CADD pump.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	FLUOROURACIL 5 GRAM/100 ML INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	No	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	3.5 mL of whole blood will be collected for PK analysis of ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will be collected for analysis of receptor occupancy (4 mL). Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 5	Perform every 1 day x1		Pump Disconnect Appointment Request
  	ONC PUMP DISCONNECT APPOINTMENT REQUEST	Interval: --	Occurrences: --			Discharge Nursing Orders
  	DISCONNECT CONTINUOUS INFUSION PUMP	Interval: --	Occurrences: --	Comments:	Disconnect patient from continuous infusion pump.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 5	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	3.5 mL of whole blood will be collected for PK analysis of ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of whole blood (3.5 mL) to detect the presence of antibodies to ALX148 is to be obtained prior to the start of treatment. After Cycle 6, ADA samples will only be collected once every 4 cycles (i.e. Cycle 10, 14, etc.) until EOT. ADA samples are only collected from patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will be collected for analysis of receptor occupancy (4 mL). Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	immunophenotyping (5 mL)- Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	molecular analysis (2.5 mL)- Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Hydration
  	sodium chloride 0.9 % infusion 1,000 mL	Dose: 1,000 mL	Route: intravenous	once @ 500 mL/hr for 1 dose	Start: S					Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Chemotherapy
  	CISplatin (PLATINOL) 100 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 100 mg/m2	Route: intravenous	once over 1 Hours for 1 dose			Offset: 2 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CISPLATIN 1 MG/ML INTRAVENOUS SOLUTION	Medications	100 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes	MANNITOL 25 % INTRAVENOUS SOLUTION	Additives	 	No	Yes			  	CARBOplatin (PARAplatin) in sodium chloride 0.9% 250 mL chemo IVPB	AUC: 5 Use AUC	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 3 Hours	Instructions:	Use minimum serum creatinine 0.7 mg/dL for Carboplatin AUC dosing. HOLD and notify provider if SCr increase by GREATER than or EQUAL to 0.5 mg/dL from baseline or SCr GREATER than 1.4.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CARBOPLATIN 10 MG/ML INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes				Chemotherapy
  	fluorouraciL (ADRUCIL) 1,000 mg/m2 in sodium chloride 0.9% 100 mL chemo infusion - AMBULATORY PUMP	Dose: 1,000 mg/m2	Route: intravenous	once over 96 Hours for 1 dose			Offset: 4 Hours	Instructions:	Nurses to chart as GIVEN on the MAR.  Administer via CADD pump.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	FLUOROURACIL 5 GRAM/100 ML INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	No	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	3.5 mL of whole blood will be collected for PK analysis of ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will be collected for analysis of receptor occupancy (4 mL). Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 5	Perform every 1 day x1		Pump Disconnect Appointment Request
  	ONC PUMP DISCONNECT APPOINTMENT REQUEST	Interval: --	Occurrences: --			Discharge Nursing Orders
  	DISCONNECT CONTINUOUS INFUSION PUMP	Interval: --	Occurrences: --	Comments:	Disconnect patient from continuous infusion pump.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 6	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 10	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	3.5 mL of whole blood will be collected for PK analysis of ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of whole blood (3.5 mL) to detect the presence of antibodies to ALX148 is to be obtained prior to the start of treatment. After Cycle 6, ADA samples will only be collected once every 4 cycles (i.e. Cycle 10, 14, etc.) until EOT. ADA samples are only collected from patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will be collected for analysis of receptor occupancy (4 mL). Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	immunophenotyping (5 mL)- Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	molecular analysis (2.5 mL)- Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Hydration
  	sodium chloride 0.9 % infusion 1,000 mL	Dose: 1,000 mL	Route: intravenous	once @ 500 mL/hr for 1 dose	Start: S					Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Chemotherapy
  	CISplatin (PLATINOL) 100 mg/m2 in sodium chloride 0.9% 250 mL chemo IVPB	Dose: 100 mg/m2	Route: intravenous	once over 1 Hours for 1 dose			Offset: 2 Hours	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CISPLATIN 1 MG/ML INTRAVENOUS SOLUTION	Medications	100 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes	MANNITOL 25 % INTRAVENOUS SOLUTION	Additives	 	No	Yes			  	CARBOplatin (PARAplatin) in sodium chloride 0.9% 250 mL chemo IVPB	AUC: 5 Use AUC	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 3 Hours	Instructions:	Use minimum serum creatinine 0.7 mg/dL for Carboplatin AUC dosing. HOLD and notify provider if SCr increase by GREATER than or EQUAL to 0.5 mg/dL from baseline or SCr GREATER than 1.4.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	CARBOPLATIN 10 MG/ML INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	No	Yes				Chemotherapy
  	fluorouraciL (ADRUCIL) 1,000 mg/m2 in sodium chloride 0.9% 100 mL chemo infusion - AMBULATORY PUMP	Dose: 1,000 mg/m2	Route: intravenous	once over 96 Hours for 1 dose			Offset: 4 Hours	Instructions:	Nurses to chart as GIVEN on the MAR.  Administer via CADD pump.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	FLUOROURACIL 5 GRAM/100 ML INTRAVENOUS SOLUTION	Medications	1,000 mg/m2	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	No	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	3.5 mL of whole blood will be collected for PK analysis of ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will be collected for analysis of receptor occupancy (4 mL). Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 5	Perform every 1 day x1		Pump Disconnect Appointment Request
  	ONC PUMP DISCONNECT APPOINTMENT REQUEST	Interval: --	Occurrences: --			Discharge Nursing Orders
  	DISCONNECT CONTINUOUS INFUSION PUMP	Interval: --	Occurrences: --	Comments:	Disconnect patient from continuous infusion pump.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 7	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 8	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	CT is the preferred modality, but use of MRI is permissible. Order MRI if clinically appropriate. 
The first on-study CT or MRI scans will be performed after 8 weeks (±7 days) from the start of study treatment (C1D1) and will continue every 8 weeks (±7 days) for the first 18 months on study or until disease progression by RECIST v1.1 or death, or until starting a new treatment for the disease under study, or withdrawal of consent.
			Imaging
  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT SOFT TISSUE NECK W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 9	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 10	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of whole blood (3.5 mL) to detect the presence of antibodies to ALX148 is to be obtained prior to the start of treatment. After Cycle 6, ADA samples will only be collected once every 4 cycles (i.e. Cycle 10, 14, etc.) until EOT. ADA samples are only collected from patients receiving ALX148.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 11	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 12	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	CT is the preferred modality, but use of MRI is permissible. Order MRI if clinically appropriate. 
The first on-study CT or MRI scans will be performed after 8 weeks (±7 days) from the start of study treatment (C1D1) and will continue every 8 weeks (±7 days) for the first 18 months on study or until disease progression by RECIST v1.1 or death, or until starting a new treatment for the disease under study, or withdrawal of consent.
			Imaging
  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT SOFT TISSUE NECK W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 13	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 14	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of whole blood (3.5 mL) to detect the presence of antibodies to ALX148 is to be obtained prior to the start of treatment. After Cycle 6, ADA samples will only be collected once every 4 cycles (i.e. Cycle 10, 14, etc.) until EOT. ADA samples are only collected from patients receiving ALX148.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 15	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 16	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	CT is the preferred modality, but use of MRI is permissible. Order MRI if clinically appropriate. 
The first on-study CT or MRI scans will be performed after 8 weeks (±7 days) from the start of study treatment (C1D1) and will continue every 8 weeks (±7 days) for the first 18 months on study or until disease progression by RECIST v1.1 or death, or until starting a new treatment for the disease under study, or withdrawal of consent.
			Imaging
  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT SOFT TISSUE NECK W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 17	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 18	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of whole blood (3.5 mL) to detect the presence of antibodies to ALX148 is to be obtained prior to the start of treatment. After Cycle 6, ADA samples will only be collected once every 4 cycles (i.e. Cycle 10, 14, etc.) until EOT. ADA samples are only collected from patients receiving ALX148.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 19	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 20	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	CT is the preferred modality, but use of MRI is permissible. Order MRI if clinically appropriate. 
The first on-study CT or MRI scans will be performed after 8 weeks (±7 days) from the start of study treatment (C1D1) and will continue every 8 weeks (±7 days) for the first 18 months on study or until disease progression by RECIST v1.1 or death, or until starting a new treatment for the disease under study, or withdrawal of consent.
			Imaging
  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT SOFT TISSUE NECK W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 21	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 22	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of whole blood (3.5 mL) to detect the presence of antibodies to ALX148 is to be obtained prior to the start of treatment. After Cycle 6, ADA samples will only be collected once every 4 cycles (i.e. Cycle 10, 14, etc.) until EOT. ADA samples are only collected from patients receiving ALX148.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 23	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 24	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	CT is the preferred modality, but use of MRI is permissible. Order MRI if clinically appropriate. 
The first on-study CT or MRI scans will be performed after 8 weeks (±7 days) from the start of study treatment (C1D1) and will continue every 8 weeks (±7 days) for the first 18 months on study or until disease progression by RECIST v1.1 or death, or until starting a new treatment for the disease under study, or withdrawal of consent.
			Imaging
  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT SOFT TISSUE NECK W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 25	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 26	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of whole blood (3.5 mL) to detect the presence of antibodies to ALX148 is to be obtained prior to the start of treatment. After Cycle 6, ADA samples will only be collected once every 4 cycles (i.e. Cycle 10, 14, etc.) until EOT. ADA samples are only collected from patients receiving ALX148.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 27	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 28	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	CT is the preferred modality, but use of MRI is permissible. Order MRI if clinically appropriate. 
The first on-study CT or MRI scans will be performed after 8 weeks (±7 days) from the start of study treatment (C1D1) and will continue every 8 weeks (±7 days) for the first 18 months on study or until disease progression by RECIST v1.1 or death, or until starting a new treatment for the disease under study, or withdrawal of consent.
			Imaging
  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT SOFT TISSUE NECK W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 29	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 30	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of whole blood (3.5 mL) to detect the presence of antibodies to ALX148 is to be obtained prior to the start of treatment. After Cycle 6, ADA samples will only be collected once every 4 cycles (i.e. Cycle 10, 14, etc.) until EOT. ADA samples are only collected from patients receiving ALX148.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 31	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 32	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	CT is the preferred modality, but use of MRI is permissible. Order MRI if clinically appropriate. 
The first on-study CT or MRI scans will be performed after 8 weeks (±7 days) from the start of study treatment (C1D1) and will continue every 8 weeks (±7 days) for the first 18 months on study or until disease progression by RECIST v1.1 or death, or until starting a new treatment for the disease under study, or withdrawal of consent.
			Imaging
  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT SOFT TISSUE NECK W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 33	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 34	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of whole blood (3.5 mL) to detect the presence of antibodies to ALX148 is to be obtained prior to the start of treatment. After Cycle 6, ADA samples will only be collected once every 4 cycles (i.e. Cycle 10, 14, etc.) until EOT. ADA samples are only collected from patients receiving ALX148.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 35	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 6	Interval: --	Occurrences: --			Line Flush
  	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Nursing Orders
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Brief physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Concomitant treatments
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Order 12-lead ECG as clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mEq/L; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify physicians if: 
o ANC LESS than 1000, platelets LESS Than 100,000; 
o SCr GREATER than 1.5 or CrCl LESS than 60; 
o ST or ALT GREATER than or EQUAL to 3x ULN and TBili GREATER than or EQUAL to 2x ULN (or from baseline, whichever is smaller).
			Pre-Medications
  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S				  	ondansetron (ZOFRAN) 16 mg, dexAMETHasone (DECADRON) 12 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 16 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg	Main Ingredient	No	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	12 mg	Yes	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S					Chemotherapy
  	INV-Pembrolizumab (AT148004/pro00035973/Zhang) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 - 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.
	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG/4 ML INTRAVENOUS SOLN (AT148004/PRO00035973/ZHANG)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes			  	INV-ALX148 infusion (AT148004/Pro00035973/Zhang) 45 mg/kg (Treatment Plan)	Dose: 45 mg/kg	Route: intravenous	once for 1 dose			Offset: 60 Minutes	Instructions:	Prepared dose contains open label active drug ALX148. Administer intravenously (no filter needed) over approximately 60-90 minutes. Prepared bag is stable for 4 hours room temperature. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	Observe pts for approx. 2 hours post ALX148 infusion as clinically indicated.
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only – itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 – MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms – shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Fexofenadine 180 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	fexofenadine (ALLEGRA) tablet 180 mg	Dose: 180 mg	Route: oral	PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
EOT	Repeat 1 time	Cycle length: 6 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Complete physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	CT is the preferred modality, but use of MRI is permissible. Order MRI if clinically appropriate. 
The first on-study CT or MRI scans will be performed after 8 weeks (±7 days) from the start of study treatment (C1D1) and will continue every 8 weeks (±7 days) for the first 18 months on study or until disease progression by RECIST v1.1 or death, or until starting a new treatment for the disease under study, or withdrawal of consent.
			Imaging
  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT SOFT TISSUE NECK W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	3.5 mL of whole blood will be collected for PK analysis of ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collection of whole blood (3.5 mL) to detect the presence of antibodies to ALX148 is to be obtained prior to the start of treatment. After Cycle 6, ADA samples will only be collected once every 4 cycles (i.e. Cycle 10, 14, etc.) until EOT. ADA samples are only collected from patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples will be collected for analysis of receptor occupancy (4 mL). Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	immunophenotyping (5 mL)- Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	molecular analysis (2.5 mL)- Samples will only be collected for the first 6 cycles (No samples after Cycle 6). RO samples are only collected for patients receiving ALX148.
					
FU D28	Repeat 1 time	Cycle length: 62 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Complete physical exam
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	TOTAL BILIRUBIN	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
					
FU D90	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Adverse events