Phase II study on first-line treatment of NIVolumab in combination with folfoxiri/bevacizumab in patients with Advanced COloRectal cancer RAS or BRAF mutated – NIVACOR trial (GOIRC-03-2018)

Table 4 Study assessments

Procedures	Screening (−28 days)	Cycle 1,3,5,7^a (+ 3 days)	Cycle 2,4,6,8 ^a (+ 3 days)	Maintenance ^a (+ 3 days)	End of treatment ^a	Post-treatment Follow up ^a
Signed informed consent	X
Medical history and baseline conditions	X
Physical examination	X	X	X	X	X
Parameters^b	X	X	X	X	X
Hematology and serum chemistry^c	X	X	X	X	X
Protein dipstick	X	X	X	X	X
Adverse Events	X	X	X	X	X
Radiological assessment^e, CEA^c	X	X		X	X
QLQ-C30 questionnaire^f	X		X	X	X
Blood sample^g	X				X
FOLFOXIRI administration		X	X
Nivolumab and Bevacizumab administration		X	X	X
Survival follow-up						X

^aEach cycle is 14 days. Study drugs administration occurs on day1 (+/− 3 days) of each cycle. All clinical and laboratory assessments must occur within 3 days prior the administration. The end of treatment should occur within 30 days after last dose of study treatment. The post-treatment follow-up visit occur every 3 months (+/− 14 days) for 3 years
^bVital signs will include: weight, respiratory rate, pulse rate, temperature and systolic and diastolic blood pressure. At baseline height and BSA
^cHematology analysis (within 7 days before Cycle 1) consist of: hemoglobin, WBC and platelet count, BUN, creatinine, glucose, total bilirubin, sodium, potassium, calcium, AST, ALT, alkaline phosphatase, LDH, albumin. CEA will be tested every 8 weeks with radiological assessment. Amylase, lipase, TSH, FT3, FT4, will be done on cycle 2,4,6,8
^dIf proteinuria is 2+, should undergo a 24-h urine collection and must demonstrate 1 g of protein/24 h
^eRadiological assessment will be performed within 28 days prior to start of study treatment and every 8 weeks (± 1 week), regardless cycle of treatment; in details, during chemotherapy phase prior to cycle 5, at the end of chemotherapy (cycle 8)
^fQLQ-C30 will be completed at baseline, at cycles 4 and 8 of chemotherapy phase, every 4 cycles thereafter and at end of treatment visit
^gBlood sample will be collected at baseline, prior to cycle 5, at the end of chemotherapy and at time of progression

ISSN: 1471-2407