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OP RESEARCH PRO00039131 V940-009 PRE-RANDOMIZATION KIM	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	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: Protocol Amendment English 30 Jul 2025 (VV-TMF-23678288).pdf
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Full Physical exam:
- Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy).
- Only required if participants did not consent in the Neoadjuvant Phase.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Directed physical exam:
- Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy)
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	- Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy).  
- Only required if participants did not consent in the Neoadjuvant Phase.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	- Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy). 
- Temperature, pulse, respirations and BP.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG: 
- Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy). 
- Performed within 7 days before C1D1.
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	- Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy). 
- Only required if participants did not consent in the Neoadjuvant Phase. 
- A 6 lead is allowed if institutional SOC.
		  	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Place order for MRI if clinically appropriate. 
Baseline scan should be performed post discharge from hospital and within 6 weeks prior to randomization. All adjuvant and posttreatment scanning visits are calculated from the date of randomization. 
Refer to section 8.2.1 of the protocol.
		  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Place order for CT if clinically appropriate. 
Must be performed within 6 months before randomization.
Rule out metastasis
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Whole body FDG-PET scan. 
Must be performed within 6 months before randomization. 
Must include skull base to mid-thigh.
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	- Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy). 
- Only if required per Section 5.2 and/or Appendix 7.
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	- Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy). 
- Only if required per Section 5.2 and/or Appendix 7.
		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --	Comments:	- Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy). 
- Only if required per Section 5.2 and/or Appendix 7.
		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	- Or HBV DNA. Place order if appropriate.
- Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy). 
- Only if required per Section 5.2 and/or Appendix 7.
		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --	Comments:	- Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy). 
- Only if required per Section 5.2 and/or Appendix 7.
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	- Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy). 
- As required for PONCBP (see appendix 5 of the protocol) Only for participants who enter the study after surgery.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy)
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy)
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy)
		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --	Comments:	Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy)
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	- Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy). 
- Per institutional SOC; if blood or protein is abnormal perform microscopic exam.
		  	T3	Interval: --	Occurrences: --	Comments:	Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy)
		  	T4	Interval: --	Occurrences: --	Comments:	Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy)
		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy)
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	- Within 0-12 weeks after surgery, (up to 16 weeks if participant had post op radiotherapy). 
- Negative test required within 24 hr (urine test) or 72 hr (serum test) before dosing. 
- See Section 8.3.5 in the protocol.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Blood for NGS and generation of V940