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RSH PRO00036343 / IMCGP100-203 / BASELINE SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRE-SCREENING, TEBE-AM, BASELINE, IMCGP100

Baseline/Screening( up to 28 days and then Randomization)	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 0 days x1			Research tolerance: -0/+0 days	Nursing Orders
  	CONSENT OBTAINED	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Obtained DNA HLA-A typing
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Demography/medical history. include a history of smoking, tuberculosis, HIV infection, and hepatitis B and C. Note: Testing for tuberculosis, HIV, and hepatitis B and C is not required unless mandated by the local health authority or based on strong clinical suspicion.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Diagnosis, BRAF status, LDH status, extent of cancer.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior anticancer therapy.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Standards.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	NURSING COMMUNICATION - DO NOT USE IN ORDER SETS	Interval: Once	Occurrences: --	Comments:	Full Physical Exam
 - A full physical examination is to be performed on Day -1 or pre-dose on Day 1.
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	HEMOGLOBIN	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	ALBUMIN LEVEL	Interval: --	Occurrences: --		  	ALKALINE PHOSPHATASE	Interval: --	Occurrences: --		  	ALT (SGPT)	Interval: --	Occurrences: --		  	AST (SGOT)	Interval: --	Occurrences: --		  	CALCIUM LEVEL	Interval: --	Occurrences: --		  	CHLORIDE LEVEL	Interval: --	Occurrences: --		  	POTASSIUM LEVEL	Interval: --	Occurrences: --		  	CREATININE LEVEL	Interval: --	Occurrences: --		  	GLUCOSE LEVEL	Interval: --	Occurrences: --		  	LACTATE DEHYDROGENASE (LDH)	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	SODIUM LEVEL	Interval: --	Occurrences: --		  	TOTAL BILIRUBIN	Interval: --	Occurrences: --	Comments:	also measure direct and indirect bilirubinif total bilirubin is Grade > 1
		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	BUN LEVEL	Interval: --	Occurrences: --		  	CK ISOENZYMES	Interval: --	Occurrences: --	Comments:	also measure creatine kinase-MB if creatine phosphokinase is Grade > 3.
		  	CK-MB	Interval: --	Occurrences: --		  	TRIGLYCERIDES	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	URINALYSIS, DIPSTICK ONLY	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --	Comments:	if thyroid-stimulating hormone is suppressed but free T4 is normal.
			Labs
  	CORTISOL LEVEL, AM	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Procedures
  	BIOPSY	Interval: --	Occurrences: --	Comments:	This sample may be archival if taken = 5 years prior to visit. Archival samples may be provided at any time during[RAC1]  study enrollment. Biopsy assessments are optional but encouraged.
		  	PUNCH BIOPSY SKIN EA ADDL LESION 	Interval: --	Occurrences: --	Comments:	Per clinical requirement during treatment.
			Imaging
  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --		  	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Brain imaging (head CT or MRI with contrast) must be performed at enrollment. If no brain metastases are observed at the enrollment scan, future brain imaging is to be performed at the discretion of the investigator. If brain metastases are detected at the enrollment, brain imaging should be aligned with subsequent on-treatment tumor assessment timepoints.
				Prior to the treatment	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medications.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Demography/medical history.
include a history of smoking, tuberculosis, HIV infection, and hepatitis B and C. Note: Testing for tuberculosis[RAC1] , HIV, and hepatitis B and C is not required unless mandated by the local health authority or based on strong clinical suspicion.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Standards.
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EORTC-QLQ-C30. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.FU (30) This is to be completed only at 30-day time point after the last dose.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. To avoid influence of response, participants must complete the self-administered questionnaires in the clinic using an electronic device before any other clinical.The EQ-5D-5L should be completed before the EORTC-QLQ-C30. FU (30) This is to be completed only at 30-day time point after the last dose.
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
  	INTERFERON GAMMA	Interval: --	Occurrences: --		  	INTERLEUKIN 6	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --