NCT06353854 Prospective National Cohort Evaluating Predictive Biomarkers of Resistance to Immunotherapy in Patients With MSI/dMMR Metastatic Colorectal Cancer (CORESIM)
| NCT ID | NCT06353854 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federation Francophone de Cancerologie Digestive |
| Condition | Colorectal Cancer Metastatic |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-02-12 |
| Primary Completion | 2029-02-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2024-02-12 with a primary completion date of 2029-02-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Aziz ZAANAN, MD, PhD
PRINCIPAL INVESTIGATOR
Hôpital Européen Georges Pompidou APHP
Frequently Asked Questions
Who can join the NCT06353854 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06353854 currently recruiting?
Yes, NCT06353854 is actively recruiting participants. Contact the research team at aziz.zaanan@aphp.fr for enrollment information.
Where is the NCT06353854 trial being conducted?
This trial is being conducted at Bayonne, France, Beauvais, France, Besançon, France, Boujan-sur-Libron, France and 11 additional locations.
Who is sponsoring the NCT06353854 clinical trial?
NCT06353854 is sponsored by Federation Francophone de Cancerologie Digestive. The principal investigator is Aziz ZAANAN, MD, PhD at Hôpital Européen Georges Pompidou APHP. The trial plans to enroll 600 participants.
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