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

Recruitingn/aAges 18 Years - anyAllFederation Francophone de Cancerologie Digestive
NCT06353854 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients over 18 years old * Histologically confirmed colorectal adenocarcinoma with unresectable metastasis(s) receiving immunotherapy as first-line treatment with pembrolizumab * Tumor with microsatellite instability determined by immunohistochemistry (loss of expression of MLH1, MSH2, MSH6 and/or PMS2) and/or by molecular biology (MSI-H on microsatellite analysis from tumor DNA according to practice routine of the center) Exclusion Criteria: * Patients with another concomitant cancer at the time of diagnosis requiring systemic treatment or impacting prognosis according to the medical team. * Previous treatment with anti-PD1 or anti-PDL1. * Previous treatment with chemotherapy +/- targeted therapy for MSI/dMMR metastatic colorectal cancer. * Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining non-opposition or consent; inability to be followed in the same center throughout the follow-up period for geographical reasons). * Pregnant women * persons under court protection or under protective supervision (guardianship or curatorship) * Opposition to participation in the study.
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What it tests

  • Not listed
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Where

20 sites
Ch - Centre Hospitalier de La Côte Basque
Bayonne, France
Ch - Ch Beauvais
Beauvais, France
CH Jean Minjoz
Besançon, France
Polyclinique Saint Privat
Boujan-sur-Libron, France
Ch - Duchenne
Boulogne-sur-Mer, France
Ch - Centre Hospitalier Metropole Savoie
Chambéry, France
Ch - Centre Hospitalier de Cholet
Cholet, France
CH - Compiegne
Compiègne, France

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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