Prospective National Cohort Evaluating Predictive Biomarkers of Resistance to Immunotherapy in Patients With MSI/dMMR Metastatic Colorectal Cancer (CORESIM)
About this study
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.
- Condition
- Colorectal Cancer Metastatic, Microsatellite Instability-High Colorectal Cancer
- Sponsor
- Federation Francophone de Cancerologie Digestive
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 5
- Minimum age: 18 years
- Study condition: Colorectal Cancer Metastatic, Microsatellite Instability-High Colorectal Cancer
- 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 7
- 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
20 sites, 20 recruiting
Polyclinique Saint Privat
Boujan-sur-Libron, France
Centre Hospitalier Regional et Universitaire de Lille
Lille, France
Prive - Institut Montsouris
Paris, France
Ch - Centre Hospitalier de La Côte Basque
Bayonne, France
Ch - Ch Beauvais
Beauvais, France
CH Jean Minjoz
Besançon, France
and 14 more sites on ClinicalTrials.gov
Contact
-
Aziz ZAANAN, MD, PhD
03 80 66 80 13 aziz.zaanan@aphp.fr
-
Leathicia NDONG, MD
0661804266 cohorte.coresim@ffcd.fr
Potential match only. Final eligibility is determined by the study team.