Clinical Trial

Prospective National Cohort Evaluating Predictive Biomarkers of Resistance to Immunotherapy in Patients With MSI/dMMR Metastatic Colorectal Cancer (CORESIM)

Study acronym: CORESIM
Recruiting
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Summary
The Keynote 117 phase III trial demonstrated the superiority of pembrolizumab (anti-PD1 monoclonal antibody) versus chemotherapy +/- targeted therapy in first-line treatment of dMMR/MSI metastatic colorectal cancer (mCRC). However, primary resistance to pembrolizumab was observed in approximately 20-30% of patients treated in the Keynote 177 study. Therefore, the identification of biomarkers predictive of resistance to immunotherapy for dMMR/MSI mCRC is necessary to better select patients who benefit the most from immunotherapy, and those for whom other therapeutic approaches should be favored.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-04-04; most recent amendment 2025-10-01.
Trial Details
NCT Number NCT06353854
Lead Sponsor Federation Francophone de Cancerologie Digestive
Conditions Colorectal Cancer Metastatic, Microsatellite Instability-High Colorectal Cancer
Enrollment 600 participants
Start Date 2024-02-12
Primary Completion 2029-02-12 (estimated)
Study Completion 2030-02-12 (estimated)
Updated on ClinicalTrials.gov 2025-10-06