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OP RESEARCH PRO00040000 EF-44 LUNAR-2 PLAN D ZHANG	

Types:      Research Oncology Treatment
Synonyms:  MAINTENANCE

Cycle 5	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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 6	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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 7	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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: 30 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	TTFields and Usage Assessment: Systemic and TTFields treatments should be initiated within 7 days of randomization and ±3 days of each other.Only Arm 1 C
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for serum/plasma biomarkers are optional and may be obtained prior to study treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2,4 and 32 (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Sample for immunophenotyping are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4 and 7 (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
			Nursing Orders
  	TREATMENT CONDITIONS 13	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 

o ANC LESS than 1,000;  
o Platelets LESS than 100,000;  

o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80;
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200. 

o AST or ALT GREATER than or EQUAL 3 x ULN, or Tbili GREATER than 1.5 x ULN;
o SCr GREATER than 1.5-3 x baseline/ULN
			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 mg/dL; 
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.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	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.			Chemotherapy
  	pembrolizumab (KEYTRUDA) 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:	Administer with low protein binding 0.22 micron in-line filter. Do not shake. Do not mix with other medications.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLUTION	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				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 Cetirizine 10 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), Cetirizine 10 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				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once 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					
Post Treatment Termination ( PTT)	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant Medications Recording
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Directed physical examination
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status: Does not have to be done if Screening ECOG was performed within 3 days prior to randomization.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Events and Device Deficiencies: Adverse events will be collected until last study follow up visit or for 30 days following treatment termination, the later of the two.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include heart rate, blood pressure, respiratory rate, body temperature
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Subsequent Antineoplastic Therapy and progression Status: The investigator or qualified designee will review all new antineoplastic therapy initiated after the last dose of the study systemic therapy/discontinuation of TTFields.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Survival status: Following the last study visit, subjects will be followed q3m ±21 days for survival. Day 0 for calculation of survival follow-up window is date of post treatment termination visit or the last follow up visit.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	After Cycle 1, lab samples can be collected up to 3 days prior to Day 1 of subsequent cycles.
If the 1st cycle of systemic therapy is administered 10 days or less after screening tests, repeated tests are not required.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	As clinically indicated.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Samples for correlative studies are optional and may be obtained prior to treatment initiation and pembrolizumab and chemotherapy dose at Cycles 2, 4, 32 and at the time of disease progression (±3 days).
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Radiological review to be performed following each imaging procedure and should include assessment per RECIST v1.1 iRECIST. Times are calculated from randomization. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI if CT is contraindicated. 
Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Imaging procedures to be performed at week 6 and 12 (±7 days).
Imaging procedures to be performed at week 18 (±7 days) and q9w (±7 days) thereafter until 63 weeks from randomization, and q15w (±7 days) thereafter, with additional scans as clinically indicated. The timing for imaging studies should follow calendar days and should not be adjusted for delays in cycle starts. The same imaging technique should be used in a subject throughout the study. After the first documentation of progression (if the subject is clinically stable) or response per iRECIST repeat imaging for confirmation may be performed. Confirmatory imaging may be performed as early as 28 days later; alternately, the scan performed at the next scheduled time point may be used as confirmation
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
					
Survival FUP (SFU)	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Subsequent Antineoplastic Therapy and progression Status: The investigator or qualified designee will review all new antineoplastic therapy initiated after the last dose of the study systemic therapy/discontinuation of TTFields.
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Survival status: Following the last study visit, subjects will be followed q3m ±21 days for survival. Day 0 for calculation of survival follow-up window is date of post treatment termination visit or the last follow up visit.
			Nursing Orders
  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: 
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	EORTC QLQ-LC13:
PROs (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13) are completed at year 1 (Cycles 1-17) every 3rd cycle (q9w) while on treatment; for year 2 (Cycle 18 and beyond), PROs are completed every 4th cycle (q12w) while on treatment. PROs are also completed at post treatment termination visit and during survival follow-up for 1 year.