NCT04730544

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

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: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Colorectal Cancer Metastatic
• MSI-H Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab 480mg + Ipilimumab	Nivolumab 480 mg q4w + Ipilimumab 1 mg/kg q6w
DRUG	Nivolumab 240 mg + Ipilimumab	induction phase : Nivolumab 240 mg q3w + Ipilimumab 1 mg/kg q3w and then maintenance : Nivolumab 480 mg q4w

Timeline

• Start date: 2021-05-21
• Primary completion: 2027-04-01
• Completion: 2028-04-01
• First posted: 2021-01-29
• Last updated: 2025-06-13

Locations

19 sites across 1 country: France