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OP RESEARCH PRO00035973 NCT04675333 SCREENING ZHANG	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Study Treatment : : Refer Protocol for Management of AEs Associated with Study Treatment
Protocol Access Hyperlink: AT148004 Protocol v6.0-PA5.0 24Nov2021 Clean.pdf.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed consent: must be obtained prior to undergoing any study specific procedures.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Tumor history: Will be collected within 28 days prior to treatment start. Includes history of disease under study including details of primary diagnosis and treatment history.
		  	ONC NURSING COMMUNICATION 6	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 8	Interval: --	Occurrences: --	Comments:	Adverse events: Active reporting period to Sponsor or its designated representative begins from the time that the patient provides informed consent, which is obtained prior to the patient's participation in the study.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Complete  physical exam (including height at screening only).
		  	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 11	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 >500 msec), the ECGs should be re-evaluated by a qualified person at the institution for confirmation.
			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
		☐	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	For female patients of childbearing potential, a pregnancy test, with sensitivity of at least 25 mIU/mL, and assayed in a certified laboratory, will be performed at the start of screening (serum), at D1 of each treatment cycle immediately before investigational product administration (serum or urine).
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Dipstick is acceptable. Microscopic analyses if dipstick abnormal. No need to repeat on C1D1 if screening assessment performed within 72 hours prior to that date. If GREATER or EQUAL to 2+ protein on urine dipstick, then collect spot urine sample to calculate urine protein to creatinine ratio (UPCR).
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	CT is the preferred modality, but use of MRI is permissible. Order MRI if clinically appropriate.
			Imaging
  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT SOFT TISSUE NECK W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
		  	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Tumor assessments will include all known or suspected disease sites. CT is the preferred modality, but use of MRI is permissible. CT or MRI scans of the head, neck, chest, and abdomen (pelvis is optional).
				Day 14	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Baseline signs and symptoms: any signs and symptoms experienced within the 14 days prior to study entry.
				Day 18	Perform every 1 day x1		Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --				Day 28	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Concomitant treatments: All concomitant medications and Non-Drug Supportive Interventions should be recorded in the CRF.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Unless prohibited by local regulations, a blood sample (4 mL) will be retained for genotype analysis including but not limited to SIRPa variants.
			Labs
  	TYPE AND SCREEN	Interval: --	Occurrences: --			Procedures
  	BIOPSY	Interval: --	Occurrences: --	Comments:	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.