Overview

Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients

Status:
Recruiting
Trial end date:
2025-10-01
Target enrollment:
Participant gender:
Summary
This is a phase II, prospective, open label, one-center study for evaluation of the addition of nivolumab to the chemotherapy phase of the neoadjuvant treatment for locally advanced rectal cancer patients. Subjects must have received no prior treatment for rectal cancer (chemotherapy, radiotherapy or surgery) and no prior treatment with checkpoint inhibitors. Eligible subjects will receive chemoradiation for a period of 5 weeks, 6 cycles of chemo-immunotherapy (mFOLFOX6 + nivolumab) for a period of 12 weeks, once every 2 weeks, and will undergo surgery after 4 weeks.
Phase:
Phase 2
Details
Lead Sponsor:
Baruch Brenner
Collaborator:
Bristol-Myers Squibb
Treatments:
Capecitabine
Nivolumab