Prospective National Cohort Evaluating Predictive Biomarkers of Resistance to Immunotherapy in Patients With MSI/dMMR Metastatic Colorectal Cancer (CORESIM)
CORESIM
National French Cohort Evaluating Predictive Factors of Resistance to Immunotherapy in Patients With MSI Metastatic Colorectal Cancer
1 other identifier
observational
600
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2024
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 12, 2024
CompletedFirst Submitted
Initial submission to the registry
March 28, 2024
CompletedFirst Posted
Study publicly available on registry
April 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 12, 2030
October 6, 2025
October 1, 2025
5 years
March 28, 2024
October 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identification of predictive factors of resistance to pembrolizumab in first-line treatment of MSI and/or dMMR metastatic colorectal cancer
Primary resistance will be defined as immediate progression of the disease (at the time of the first assessment, excluding pseudoprogression) Secondary resistance will be defined as progression occurring after control of the disease.
2 years
Study Arms (2)
Retrospective group
Registration of patients treated with pembrolizumab since February 2021. Collection of tumour sample archives will be associated
Prospective group
Recruitment of metastatic colorectal cancer patients with microsatellite instability prior to the first administration of pembrolizumab immunotherapy. Blood and tumour sampling will be combined.
Eligibility Criteria
Prospective inclusion of patients receiving first-line immunotherapy with pembrolizumab (as defined in the MA) for unresectable mCRC. Patients who have received pembrolizumab in the same indication on a compassionate basis since February 2021 may also be retrospectively included in the cohort.
You may qualify if:
- 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)
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Ch - Centre Hospitalier de La Côte Basque
Bayonne, 64100, France
Ch - Ch Beauvais
Beauvais, France
CH Jean Minjoz
Besançon, 25030, France
Polyclinique Saint Privat
Boujan-sur-Libron, 34760, France
Ch - Duchenne
Boulogne-sur-Mer, France
Ch - Centre Hospitalier Metropole Savoie
Chambéry, 73011, France
Ch - Centre Hospitalier de Cholet
Cholet, 49300, France
CH - Compiegne
Compiègne, France
Ch - Chd Vendée
La Roche-sur-Yon, 85925, France
CH - Louis Pasteur
Le Coudray, France
Centre Hospitalier Regional et Universitaire de Lille
Lille, 59037, France
CH Saint Joseph - Saint Luc
Lyon, 69365, France
Caluire et Cuire - Infirmerie Protestante de Lyon
Lyon, France
Ch - Hôpital Saint Joseph
Marseille, 13285, France
CH Saint Joseph
Marseille, France
Centre Hospitalier
Mulhouse, 68070, France
CHR D'Orleans - Hopital de la Source
Orléans, 45100, France
Prive - Institut Montsouris
Paris, France
Ch - Centre Hospitalier de Soisson
Soissons, 02209, France
CH - Gustave Dron
Tourcoing, France
Biospecimen
Tumor samples archived for retrospective cohort Tumour samples archived and blood samples at 3 time points for prospective cohort
Study Officials
- PRINCIPAL INVESTIGATOR
Aziz ZAANAN, MD, PhD
Hôpital Européen Georges Pompidou APHP
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2024
First Posted
April 9, 2024
Study Start
February 12, 2024
Primary Completion (Estimated)
February 12, 2029
Study Completion (Estimated)
February 12, 2030
Last Updated
October 6, 2025
Record last verified: 2025-10