Clinical Trial

iRECIST Evaluation's Relevance for DCR in MMR/MSI Metastatic Colorectal Cancer Patients on Nivolumab and Ipilimumab

Study acronym: NIPICOL
Active, Not Recruiting Phase 2
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Summary
This is a non-randomized study, open label phase II study. The purpose of this study is to evaluate disease control rate (DCR) by RECIST and iRECIST at 12 weeks. Evaluation of RECIST and iRECIST will be done in each center in order to choose the optimal therapy (Assessment by Investigators). A centralized evaluation of RECIST and iRECIST, will be organized in Saint-Antoine.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2017-11-20; most recent amendment 2025-07-22.
Status change: Recruiting → Active, Not Recruiting 2019-02-26
Status change: Not Yet Recruiting → Recruiting 2017-12-22
Trial Details
NCT Number NCT03350126
Lead Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators: Bristol-Myers Squibb
Conditions Metastatic Cancer Colorectal
Enrollment 57 participants
Start Date 2017-12-04
Primary Completion 2020-01-10 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-07-23