Clinical Trial

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

Study acronym: NIPISAFE
Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-01-26; most recent amendment 2025-06-12.
Status change: Recruiting → Active, Not Recruiting 2025-03-24
Status change: Not Yet Recruiting → Recruiting 2021-04-06
Trial Details
NCT Number NCT04730544
Lead Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators: Bristol-Myers Squibb
Conditions Colorectal Cancer Metastatic, MSI-H Colorectal Cancer
Enrollment 96 participants
Start Date 2021-05-21
Primary Completion 2027-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2025-06-13