Prospective National Cohort Evaluating Predictive Biomarkers of Resistance to Immunotherapy in Patients With MSI/dMMR Metastatic Colorectal Cancer (CORESIM)
Recruiting · NCT06353854 · Observational (researchers observe without assigning treatment) · Lead sponsor: Federation Francophone de Cancerologie Digestive
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
20 locations listed.
- 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
- Ch - Chd Vendée - La Roche-sur-Yon, France
- CH - Louis Pasteur - Le Coudray, France
- Centre Hospitalier Regional et Universitaire de Lille - Lille, France
- CH Saint Joseph - Saint Luc - Lyon, France
- Caluire et Cuire - Infirmerie Protestante de Lyon - Lyon, France
- Ch - Hôpital Saint Joseph - Marseille, France
- CH Saint Joseph - Marseille, France
- Centre Hospitalier - Mulhouse, France
- CHR D'Orleans - Hopital de la Source - Orléans, France
- Prive - Institut Montsouris - Paris, France
- Ch - Centre Hospitalier de Soisson - Soissons, France
- CH - Gustave Dron - Tourcoing, France