Evaluating biomarkers for immunotherapy resistance in metastatic colorectal cancer
National French Cohort Evaluating Predictive Factors of Resistance to Immunotherapy in Patients With MSI Metastatic Colorectal Cancer
Federation Francophone de Cancerologie Digestive · NCT06353854
This study is trying to find out which patients with advanced colorectal cancer might not respond to a specific immunotherapy treatment called pembrolizumab, to help doctors choose the best options for their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Federation Francophone de Cancerologie Digestive (other) |
| Drugs / interventions | pembrolizumab, chemotherapy, immunotherapy |
| Locations | 20 sites (Bayonne and 19 other locations) |
| Trial ID | NCT06353854 on ClinicalTrials.gov |
What this trial studies
This study aims to identify predictive biomarkers of resistance to pembrolizumab in patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) metastatic colorectal cancer. It will involve a national cohort of patients in France, including both retrospective and prospective data collection from over 150 centers. The study will follow patients treated with pembrolizumab, assessing their outcomes and identifying factors that may predict resistance to this immunotherapy. The goal is to enhance patient selection for immunotherapy and improve treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with histologically confirmed unresectable metastatic colorectal adenocarcinoma receiving pembrolizumab as first-line treatment.
Not a fit: Patients with other concurrent cancers requiring systemic treatment or those who have previously received anti-PD1 or anti-PDL1 therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better patient selection for immunotherapy, improving outcomes for those with metastatic colorectal cancer.
How similar studies have performed: Other studies have shown success in identifying biomarkers for immunotherapy resistance, but this specific approach is novel in the context of MSI/dMMR metastatic colorectal cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bayonne and 19 other locations
- 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)
Study contacts
- Principal investigator: Aziz ZAANAN, MD, PhD — Hôpital Européen Georges Pompidou APHP
- Study coordinator: Aziz ZAANAN, MD, PhD
- Email: aziz.zaanan@aphp.fr
- Phone: 03 80 66 80 13
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Cancer Metastatic, Microsatellite Instability-High Colorectal Cancer, immunotherapy resistance