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OP RESEARCH PRO00037808 D361DC00001 SUN SCREENING	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed consent - Written informed consent and any locally required privacy act document authorization must be obtained prior to performing any protocol-specific procedures, including screening/baseline evaluations
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demography/baseline characteristics
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Medical/Surgical history
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Previous cancer therapy
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Germline status - (local testing), if available
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination -- will include an assessment of the following: general appearance, respiratory, cardiovascular, abdomen skin, head and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, musculoskeletal (including spine and extremities), urogenital, dermatological, gastrointestinal, endocrine, hematologic/lymphatic, and neurological systems.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Including blood pressure, pulse rate and body temperature
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes).
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	An initial bone scan must be performed within 4 weeks prior to Cycle 1, Week 1, Day 1 and repeated as necessary. Bone scintigraphy is the preferred modality. If a participant had a
Choline PET-CT as part of the routine clinical management performed less than 28 days before randomization, it may be utilized as screening scan to document bone disease.
However, if FDG-PET-CT is used, a dedicated high-quality structural CT or MRI of the relevant part of the skeleton is recommended to ensure that any changes represent a true bone metastasis and not a non-malignant lesion eg, an inflammatory lesion.
		  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Baseline RECIST v1.1 assessments will be performed using CT scans of the chest, abdomen and pelvis from CT (preferred) or MRI and should be performed as close as possible to the start of treatment. RECIST v1.1 follow-up assessments will include CT scans of thorax, abdomen and pelvis (or MRI where CT is contraindicated) for all participants. Any other sites at which new disease is suspected should also be appropriately imaged. Expedited analysis per BICR will be triggered upon investigator-assessed progression. Results of the BICR of scans for those participants with disease progression as assessed by the investigator will be reported back promptly to sites. Please refer to Section 8.1.3 for more details.
		  	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Bidimensional ECHO is the preferred modality because of the global technetium [Tc-99m] shortage (but MUGA can be used alternatively). The modality of the cardiac function assessments must be consistent within participant ie, if ECHO is used for the screening assessment and a follow-up assessment is clinically indicated, then ECHO should also be used for subsequent scans if required. Participants should also be examined using the same machine and operator whenever possible.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Perform ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	ESTRADIOL LEVEL	Interval: --	Occurrences: --	Comments:	Only needed for some participants, See Section 8.2.4 and Appendix G.
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Only needed for some participants, See Section 8.2.4 and Appendix G.
			Nursing Orders
  	ONC NURSING COMMUNICATION 59	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.