RecruitingNCT06353854

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

National French Cohort Evaluating Predictive Factors of Resistance to Immunotherapy in Patients With MSI Metastatic Colorectal Cancer


Sponsor

Federation Francophone de Cancerologie Digestive

Enrollment

600 participants

Start Date

Feb 12, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study follows patients with a specific type of colorectal cancer — one that has a genetic marker called MSI/dMMR — who are receiving immunotherapy (pembrolizumab) as their first treatment. Researchers want to identify biological markers in the blood and tumor that predict who will or won't respond well to this immunotherapy. **You may be eligible if...** - You are 18 or older with confirmed colorectal cancer that has spread and cannot be surgically removed - Your tumor has been tested and shows the MSI-H (microsatellite instability-high) marker - You are starting pembrolizumab as your first-line treatment **You may NOT be eligible if...** - You have another active cancer requiring treatment at the same time - You have previously received anti-PD-1 or anti-PD-L1 immunotherapy - You have previously received chemotherapy or targeted therapy for your metastatic colorectal cancer - You are pregnant - You have cognitive or psychological conditions that would prevent you from giving consent or following up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(20)

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

View Full Details on ClinicalTrials.gov

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NCT06353854


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