Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients

PHASE2RecruitingINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

April 30, 2019

Primary Completion Date

April 30, 2021

Study Completion Date

October 31, 2025

Conditions
Rectal Cancer
Interventions
DRUG

Capecitabine

Capecitabine 825 mg/m2 orally twice-daily, 5 days a week for a total of 28 days, given with radiation therapy

RADIATION

Radiation therapy

1.8 Gy/day, 5 days a week for a total of 28 days, given with Capecitabine

DRUG

mFOLFOX6

oxaliplatin 85 mg/m2, leucovorin 400 mg/m2 and fluorouracil 400 mg/m2 IV, fluorouracil 2400 mg/m2 IV (a 46 hrs CI), day 1 of each treatment cycle, every 2 weeks, given with nivolumab

DRUG

Nivolumab

Nivolumab 240mg IV, day 1 of each treatment cycle, every two weeks, given with mFOLFOX6

Trial Locations (1)

Unknown

RECRUITING

Rabin Medical Center, Beilinson Hospital, Petah Tikva

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Baruch Brenner

OTHER