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

October 1, 2025 updated by: Federation Francophone de Cancerologie Digestive

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The primary endpoint is the identification of predictive factors of resistance to pembrolizumab in first-line treatment of MSI and/or dMMR metastatic colorectal cancer

CORESIM is a retrospective and prospective multicenter national French cohort. National recruitment will be carried out in all French centers, including the FFCD, AGEO, GERCOR, and UNICANCER, representing more than 150 centers and most French sites, public and private hospitals.

In France, pembrolizumab for first-line treatment of patients with MSI mCRC was accessible via its compassionate use in February 2021, then its reimbursement was effective in June 2023 Patients treated with pembrolizumab will be included prospectively on the start date of the study, i.e. on February 2024; patients treated since February 2021 via compassionate use of pembrolizumab will be included retrospectively A total of 600 patients are expected. The theoretical duration of inclusion is set at 2 years. All patients will be followed up for 3 years.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bayonne, France, 64100
        • Not yet recruiting
        • Ch - Centre Hospitalier de La Côte Basque
        • Contact:
        • Contact:
        • Principal Investigator:
          • Franck AUDEMAR, Dr
      • Beauvais, France
      • Besançon, France, 25030
      • Boujan-sur-Libron, France, 34760
      • Boulogne-sur-Mer, France
        • Not yet recruiting
        • Ch - Duchenne
        • Contact:
        • Principal Investigator:
          • Vincent BOURGEOIS
      • Chambéry, France, 73011
      • Cholet, France, 49300
        • Not yet recruiting
        • Ch - Centre Hospitalier de Cholet
        • Contact:
        • Contact:
        • Principal Investigator:
          • You-Heng LAM, Dr
      • Compiègne, France
        • Not yet recruiting
        • CH - Compiegne
        • Principal Investigator:
          • Virginie SEBBAGH
        • Contact:
      • La Roche-sur-Yon, France, 85925
        • Not yet recruiting
        • Ch - Chd Vendée
        • Contact:
        • Contact:
        • Principal Investigator:
          • Margot LALY, Dr
      • Le Coudray, France
        • Not yet recruiting
        • CH - Louis Pasteur
        • Contact:
      • Lille, France, 59037
        • Recruiting
        • Centre Hospitalier Regional et Universitaire de Lille
        • Contact:
          • ANTONY TURPIN, MD
          • Phone Number: 0320445461
      • Lyon, France, 69365
      • Lyon, France
        • Not yet recruiting
        • Caluire et Cuire - Infirmerie Protestante de Lyon
        • Principal Investigator:
          • Johannes HARTWIG
        • Sub-Investigator:
          • David TAVAN
        • Contact:
      • Marseille, France, 13285
        • Not yet recruiting
        • Ch - Hôpital Saint Joseph
        • Principal Investigator:
          • Hervé PERRIER, Dr
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Christelle BASTHISTE-PELE, Dr
        • Sub-Investigator:
          • Patrick BEAURAIN, Dr
        • Sub-Investigator:
          • Hélène BRUNETEAU, Dr
        • Sub-Investigator:
          • Aurélie CAMOIN, Dr
        • Sub-Investigator:
          • Annick CHICOUENE-BRUNELLE, Dr
        • Sub-Investigator:
          • Christophe LAPLACE, Dr
        • Sub-Investigator:
          • Nadjet SAADALLAH-BOUCHEMOT, Dr
      • Marseille, France
      • Mulhouse, France, 68070
        • Not yet recruiting
        • Centre hospitalier
        • Contact:
          • D. B. Vedrenne, MD
          • Phone Number: 33-3-8964-7049
      • Orléans, France, 45100
        • Not yet recruiting
        • CHR D'Orleans - Hopital de la Source
        • Contact:
          • Jean-Paul Lagasse
          • Phone Number: 33-02-3651-4704
      • Paris, France
        • Recruiting
        • Prive - Institut Montsouris
        • Principal Investigator:
          • Christophe LOUVET
        • Contact:
        • Contact:
      • Soissons, France, 02209
      • Tourcoing, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of predictive factors of resistance to pembrolizumab in first-line treatment of MSI and/or dMMR metastatic colorectal cancer
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federation Francophone de Cancerologie Digestive

Investigators

  • Principal Investigator: Aziz ZAANAN, MD, PhD, Hôpital Européen Georges Pompidou APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2024

Primary Completion (Estimated)

February 12, 2029

Study Completion (Estimated)

February 12, 2030

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 6, 2025

Last Update Submitted That Met QC Criteria

October 1, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFCD 2112-CORESIM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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