NCT03921684

Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients

Phase II Trial to Evaluate the Addition of Nivolumab to Neoadjuvant Chemoradiation With FOLFOX for Locally Advanced Rectal Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Baruch Brenner · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. Patients with cCR will be offered the alternative strategy of WW. Post-study systemic treatment, up to 4 cycles of mFOLFOX6, will be left to the discretion of the treating physician. This will be started 4-8 weeks post-operatively, or immediately after the demonstration of cCR in patients determined to undergo WW.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-10
• Primary completion: 2024-10-28
• Completion: 2029-10-01
• First posted: 2019-04-19
• Last updated: 2026-01-05

Locations

1 site across 1 country: Israel