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Clinical Trials in France / NCT06353854
Recruiting Observational

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

NCT06353854 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-02-12
Last updated
2025-10-06

Condition(s) studied

Colorectal Cancer MetastaticMicrosatellite Instability-High Colorectal Cancer

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
Ch - Centre Hospitalier de La Côte Basque Bayonne France Not Yet Recruiting
Ch - Ch Beauvais Beauvais France Not Yet Recruiting
CH Jean Minjoz Besançon France Not Yet Recruiting
Polyclinique Saint Privat Boujan-sur-Libron France Recruiting
Ch - Duchenne Boulogne-sur-Mer France Not Yet Recruiting
Ch - Centre Hospitalier Metropole Savoie Chambéry France Not Yet Recruiting
Ch - Centre Hospitalier de Cholet Cholet France Not Yet Recruiting
CH - Compiegne Compiègne France Not Yet Recruiting
Ch - Chd Vendée La Roche-sur-Yon France Not Yet Recruiting
CH - Louis Pasteur Le Coudray France Not Yet Recruiting
Centre Hospitalier Regional et Universitaire de Lille Lille France Recruiting
CH Saint Joseph - Saint Luc Lyon France Not Yet Recruiting
Caluire et Cuire - Infirmerie Protestante de Lyon Lyon France Not Yet Recruiting
Ch - Hôpital Saint Joseph Marseille France Not Yet Recruiting
CH Saint Joseph Marseille France Not Yet Recruiting
Centre Hospitalier Mulhouse France Not Yet Recruiting
CHR D'Orleans - Hopital de la Source Orléans France Not Yet Recruiting
Prive - Institut Montsouris Paris France Recruiting
Ch - Centre Hospitalier de Soisson Soissons France Not Yet Recruiting
CH - Gustave Dron Tourcoing France Not Yet Recruiting

More Federation Francophone de Cancerologie Digestive trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06353854 on ClinicalTrials.gov ↗ ← All trials in France