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NCT06353854Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 6 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
600 (estimated)
First submitted
28 Mar 2024
Start date
12 Feb 2024
Primary completion date
12 Feb 2029
Lead sponsor
Federation Francophone de Cancerologie Digestive
NCT number
NCT06353854

What you commit to

  • Study type: Observational
  • Planned participants: 600
  • From 12 Feb 2024 to the primary completion date, 12 Feb 2029
  • 20 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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).

Other

  • Pregnant women
  • persons under court protection or under protective supervision (guardianship or curatorship)
  • Opposition to participation in the study.

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ch - Centre Hospitalier de La Côte Basque
Coordinator of this site? Confirm its status
BayonneFranceNot yet recruiting
Ch - Ch Beauvais
Coordinator of this site? Confirm its status
BeauvaisFranceNot yet recruiting
CH Jean Minjoz
Coordinator of this site? Confirm its status
BesançonFranceNot yet recruiting
Polyclinique Saint Privat
Coordinator of this site? Confirm its status
Boujan-sur-LibronFranceRecruiting
CH Duchenne
Coordinator of this site? Confirm its status
Boulogne-sur-MerFranceNot yet recruiting
Ch - Centre Hospitalier Metropole Savoie
Coordinator of this site? Confirm its status
ChambéryFranceNot yet recruiting
Ch - Centre Hospitalier de Cholet
Coordinator of this site? Confirm its status
CholetFranceNot yet recruiting
CH - Compiegne
Coordinator of this site? Confirm its status
CompiègneFranceNot yet recruiting
Ch - Chd Vendée
Coordinator of this site? Confirm its status
La Roche-sur-YonFranceNot yet recruiting
CH Louis Pasteur
Coordinator of this site? Confirm its status
Le CoudrayFranceNot yet recruiting
Centre Hospitalier Regional et Universitaire de Lille
Coordinator of this site? Confirm its status
LilleFranceRecruiting
Caluire et Cuire - Infirmerie Protestante de Lyon
Coordinator of this site? Confirm its status
LyonFranceNot yet recruiting
CH Saint Joseph - Saint Luc
Coordinator of this site? Confirm its status
LyonFranceNot yet recruiting
CH Saint Joseph
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MarseilleFranceNot yet recruiting
Ch - Hôpital Saint Joseph
Coordinator of this site? Confirm its status
MarseilleFranceNot yet recruiting
Centre Hospitalier
Coordinator of this site? Confirm its status
MulhouseFranceNot yet recruiting
CHR D'Orleans - Hopital de la Source
Coordinator of this site? Confirm its status
OrléansFranceNot yet recruiting
Prive - Institut Montsouris
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Ch - Centre Hospitalier de Soisson
Coordinator of this site? Confirm its status
SoissonsFranceNot yet recruiting
CH - Gustave Dron
Coordinator of this site? Confirm its status
TourcoingFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.