Protocol Index	

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OP RESEARCH PRO00035972 / ZHANG ALX ONCOLOGY SCREENING	

Types:      Research Oncology Treatment
Synonyms:  KEYTRUDA, SQUAMOUS CELL, CARCINOMA

Screening	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Informed Consent - must be obtained prior to undergoing any study specific procedures.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Tumor History - history of disease under study including details of primary diagnosis and treatment history.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Medical History - Includes history of disease process other than the cancer under study (active or resolved) and concurrent illness. Includes prior treatments and any current medical treatments for any condition.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Physical Examination - A complete (C) physical exam (including height at screening only) will be conducted at screening.
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Height at Screening only.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Baseline Signs and Symptoms - patients will be asked about any signs and symptoms experienced within the 14 days prior to study entry.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure (BP) and pulse rate to be recorded in the sitting position after 5 minutes of rest.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	At least a 10 second strip, three consecutive 12-lead ECGs will be performed approximately 2 minutes apart to determine mean QTcF interval. If the mean QTcF is prolonged (value of
GREATER than 500 msec), the ECGs should be re-evaluated by a qualified person at the institution for confirmation.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Adverse Events (AE) - National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Concomitant Treatments - All concomitant medications and Non-Drug Supportive Interventions should be recorded in the CRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Tumor Tissue Samples - During screening, patients will be required to provide either a fresh core or incisional biopsy or an archival metastatic disease biopsy sample obtained no more than 6 months prior to the planned treatment day 1 and after the most recent therapy for HNSCC.
			Labs
  	ABO	Interval: --	Occurrences: --	Comments:	Blood type and an RBC antibody screen also known as a 'Type and Screen' are to be collected at screening. If antibody screen is positive, perform antibody identification. Include genotyping of minor red cell antigens if testing is available. Type and screen are only collected from patients receiving ALX148.
		  	TYPE AND SCREEN	Interval: --	Occurrences: --	Comments:	Blood type and an RBC antibody screen also known as a 'Type and Screen' are to be collected at screening. If antibody screen is positive, perform antibody identification. Include genotyping of minor red cell antigens if testing is available. Type and screen are only collected from patients receiving ALX148.
		  	URINALYSIS, DIPSTICK ONLY (REFLEX TO MICROSCOPIC IF NEEDED)	Interval: --	Occurrences: --	Comments:	Dipstick is acceptable. Microscopic analyses if dipstick abnormal.
		  	T3	Interval: --	Occurrences: --	Comments:	Or T3, Free
		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Or T3
		  	T4, FREE	Interval: --	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum).
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Imaging
◉	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT HEAD WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI BRAIN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
			Imaging
◉	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		◯	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		◯	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
				Day -10	Perform every 1 day x1		Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --