Evaluating biomarkers for immunotherapy resistance in metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Polyclinique Saint Privat
  Boujan-sur-Libron, France Recruiting
• Centre Hospitalier Regional et Universitaire de Lille
  Lille, France Recruiting
• Prive - Institut Montsouris
  Paris, France Recruiting
• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.