Protocol Index	

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OP RESEARCH PRO00037831 ML44719 ABDELRAHIM SCREENING	

Types:      Research Oncology Treatment
Synonyms:  

Screening	Repeat 1 time	Cycle length: 28 days	Day -28	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: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    ML44719_Abdelrahim
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Signed Informed Consent Form(s)
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Review of eligibility criteria
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Medical, surgical, and cancer histories, including demographic information: including clinically significant diseases, surgeries, cancer history (including prior cancer therapies and procedures), reproductive status, smoking history, and use of alcohol and drugs of abuse will be recorded at screening. Demographic data, including age, sex, and self-reported race or ethnicity, will also be recorded.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Complete physical examination: A complete physical examination will include, at a minimum, assessments of the head, eyes, ears, nose, and throat, and the cardiovascular, dermatologic, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurologic systems. As part of the tumor assessment, physical examinations should include the evaluation of the presence and degree of enlarged lymph nodes, hepatomegaly, and splenomegaly.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Social Determinants of Health (SDOH)
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Tumor assessment: Participants will undergo tumor assessments at screening, every 6 weeks (± 1 week) for the first 54 weeks following treatment initiation, and every 9 weeks (± 1 week) thereafter, regardless of dose delays, except in the case of patients who continue treatment after radiographic disease progression per RECIST v1.1 (Appendix 9). After disease progression, participants who continue treatment will undergo tumor assessments every 6 weeks (± 1 week) until loss of clinical benefit as determined by the investigator. Tumor assessments are to continue according to schedule in participants who discontinue treatment for reasons other than loss of clinical benefit, even if they start new non-protocol-specified anti-cancer therapy. See Section 8.1.1 for information concerning the re-assessment of lesions at subsequent tumor evaluations.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Tumor tissue sample, if available
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: To be collected and recorded on an ongoing basis throughout the study as well as at each visit. After informed consent has been obtained but prior to initiation of study treatment, only serious adverse events caused by a protocol-mandated intervention should be reported
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). 
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Measure height of patient
		  	ECG 12-LEAD	Interval: --	Occurrences: --			Procedures
  	EGD-EXTERNAL	Interval: --	Occurrences: --	Comments:	EGD may be required for participation. See Table 3 for full cohort-based requirements for EGD and treatment of varices.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	TROPONIN	Interval: --	Occurrences: --	Comments:	Perform ONLY at LabCorp, Quest, or HM ECC sites.
		  	TROPONIN T 	Interval: --	Occurrences: --		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --	Comments:	All patients will be tested for HIV locally prior to the inclusion into the study and if not in contradiction with local legislation; individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count GREATER than or EQUAL to 200/µL, and have an undetectable viral load
		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	If a participant has a positive HbsAg test and/or a positive total HbcAb test at screening, quantitative HbsAg and an HBV DNA test should be performed at screening. If local quantitative HbsAg test is not available, a qualitative HbsAg followed by quantitative HBV DNA can be performed as an alternative. Study treatment and procedures may proceed while HBV DNA is being processed, but results should be reviewed by the investigator as soon as they are available.
Patients with active HBV must have the following: 
o HBV DNA LESS than 500 IU/mL obtained within 28 days prior to initiation of study treatment. 
o Received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment (per local standard of care) for the length of the study. 
o If HBV DNA increases to GREATER than or EQUAL to 500 IU/mL, consultation with a hepatologist or gastroenterologist with specialty in HBV is recommended. The Medical Monitor is available to advise as needed.
		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --	Comments:	If a participant has a positive HbsAg test and/or a positive total HbcAb test at screening, quantitative HbsAg and an HBV DNA test should be performed at screening. If local quantitative HbsAg test is not available, a qualitative HbsAg followed by quantitative HBV DNA can be performed as an alternative. Study treatment and procedures may proceed while HBV DNA is being processed, but results should be reviewed by the investigator as soon as they are available.
Patients with active HBV must have the following: 
o HBV DNA LESS than 500 IU/mL obtained within 28 days prior to initiation of study treatment. 
o Received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment (per local standard of care) for the length of the study. 
o If HBV DNA increases to GREATER than or EQUAL to 500 IU/mL, consultation with a hepatologist or gastroenterologist with specialty in HBV is recommended. The Medical Monitor is available to advise as needed.
		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --	Comments:	If a participant has a positive HbsAg test and/or a positive total HbcAb test at screening, quantitative HbsAg and an HBV DNA test should be performed at screening. If local quantitative HbsAg test is not available, a qualitative HbsAg followed by quantitative HBV DNA can be performed as an alternative. Study treatment and procedures may proceed while HBV DNA is being processed, but results should be reviewed by the investigator as soon as they are available.
Patients with active HBV must have the following: 
o HBV DNA LESS than 500 IU/mL obtained within 28 days prior to initiation of study treatment. 
o Received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment (per local standard of care) for the length of the study. 
o If HBV DNA increases to GREATER than or EQUAL to 500 IU/mL, consultation with a hepatologist or gastroenterologist with specialty in HBV is recommended. The Medical Monitor is available to advise as needed.
		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	If a participant has a positive HbsAg test and/or a positive total HbcAb test at screening, quantitative HbsAg and an HBV DNA test should be performed at screening. If local quantitative HbsAg test is not available, a qualitative HbsAg followed by quantitative HBV DNA can be performed as an alternative. Study treatment and procedures may proceed while HBV DNA is being processed, but results should be reviewed by the investigator as soon as they are available.
Patients with active HBV must have the following: 
o HBV DNA LESS than 500 IU/mL obtained within 28 days prior to initiation of study treatment. 
o Received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment (per local standard of care) for the length of the study. 
o If HBV DNA increases to GREATER than or EQUAL to 500 IU/mL, consultation with a hepatologist or gastroenterologist with specialty in HBV is recommended. The Medical Monitor is available to advise as needed.
		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --	Comments:	If a patient has a positive HCV antibody test at screening, an HCV RNA test must also be performed to determine if the patient has an active HCV infection. Patients with a positive HCV antibody test at screening will undergo additional quantitative HCV RNA testing and must be tested locally at timepoints indicated.
		  	ALPHA FETOPROTEIN	Interval: --	Occurrences: --		  	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	Thyroid function testing: thyroid-stimulating hormone, free T3 (or total T3 for sites where free T3 is not performed), and free T4
		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Thyroid function testing: thyroid-stimulating hormone, free T3 (or total T3 for sites where free T3 is not performed), and free T4
		  	QUANTIFERON-TB GOLD PLUS, 4 TUBE	Interval: --	Occurrences: --	Comments:	Tuberculosis testing at screening is not required if the patient had a negative TB blood test within 3 months OR a positive TB blood test followed by a negative chest X-ray within 3 months of initiation of study treatment. 
Participants with a positive TB blood test, or a positive PPD skin test, followed by a negative chest X-ray may be eligible for the study
				Day -14	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: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    ML44719_Abdelrahim
			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Urine pregnancy test: if a urine pregnancy test is positive, it must be confirmed by a serum pregnancy test.
				Day -7	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: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    ML44719_Abdelrahim
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Child-Pugh Score
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medications: To be collected and recorded on an ongoing basis throughout the study as well as at each visit. After informed consent has been obtained but prior to initiation of study treatment, only serious adverse events caused by a protocol-mandated intervention should be reported
		  	MEASURE WEIGHT	Interval: --	Occurrences: --			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: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	including dipstick (pH, specific gravity, glucose, protein, ketones, and blood) and microscopic examination (sediment, RBCs, WBCs, casts, crystals, epithelial cells, and bacteria)
If urinary protein is GREATER than or EQUAL to 2+ on dipstick, then a 24-hour urine collection is required to check the total urinary protein. If there is an explanation for the positive dipstick result (e.g., menses), it should be recorded, and there is no need to perform further laboratory assessments. 
Urine dipstick for proteinuria must be LESS than 2+ within 7 days prior to initiation of study treatment. Patients discovered to have GREATER than or EQUAL to 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate LESS than 1 g of protein in 24 hours.