Two Combination Treatment Regimens of Nivolumab and Ipilimumab in Patients With dMMR and / or MSI mCRC. — NIPISAFE  

Colorectal Cancer Metastatic Clinical Trial

Official title: Analysis of the Efficacy and Safety of Two Combination Treatment Regimens of Nivolumab and Ipilimumab in Patients With dMMR and / or MSI Metastatic Colorectal Cancer: A GERCOR Open-label, Randomized, Non-comparative, Two-stage Phase II Trial (NIPISAFE).

Status Recruiting

Clinical Trial Summary

NIPISAFE is open-label, phase II study to identify a combination scheme of nivolumab and ipilimumab with a high level of clinical activity, but with a lower toxicity in MSI/dMMR metastatic colorectal cancer patients.

Clinical Trial Description

This is a randomized non-comparative two-stage phase II study with a co-primary endpoint (toxicity and progression-free survival) to evaluate two different schemes of the nivolumab and ipilimumab combination in terms of the toxicity and efficacy in MSI/dMMR metastatic colorectal cancer patients in order to identify a combination scheme with a higher level of clinical activity and a lower toxicity.

Patients will be randomized in a 2:1 ratio to receive one of the following treatments:

Experimental ARM A: Nivolumab 480 mg every 4 weeks and ipilimumab 1 mg/kg every 6 weeks for a total of 24 months of treatment Control ARM B: Nivolumab 240 mg and ipilimumab 1 mg/kg every 3 weeks for 4 dosing cycles.

Maintenance of 96 weeks: Nivolumab 480 mg every 4 weeks for 24 dosing cycles for a total of 24 months of treatment (or less in case of RECIST PD or limiting toxicity, whichever occurs first). ;

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms
• MSI-H Colorectal Cancer

• NCT number: NCT04730544
• Study type: Interventional
• Source: GERCOR - Multidisciplinary Oncology Cooperative Group
• Contact: Romain COHEN, MD
• Phone: 01 40 29 85 00
• Email: romain.cohen@aphp.fr
• Status: Recruiting
• Phase: Phase 2
• Start date: April 13, 2021
• Completion date: April 2028