protocolSection identificationModule nctId: NCT06353854, orgStudyIdInfo id: FFCD 2112-CORESIM, briefTitle: Prospective Cohort Study of Immunotherapy Resistance in Metastatic Colorectal Cancer Patients With MSI, acronym: CORESIM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2029-02-12, completionDateStruct date: 2030-02-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Federation Francophone de Cancerologie Digestive, class: OTHER, descriptionModule briefSummary: Over the last ten years, the discovery of the mechanisms by which tumours escape the control of the immune system, and in particular the T lymphocyte response, has led to the emergence of new therapeutic strategies against cancer, such as the use of "immune checkpoint inhibitors" (ICI). The immune system plays a crucial role in controlling tumour proliferation, and involves several players.Schematically, after recognition of the MHC-peptide complex by the TCR, the T lymphocyte response is modulated by several activating or inhibiting co-stimulatory signals (or "checkpoints"). The balance of these different signals determines whether the T lymphocyte (LT) is activated, resulting in the destruction of the target cell, or whether the T lymphocyte is inhibited (anergy), inducing immune tolerance. By hijacking this system through the expression of inhibitory checkpoints on its surface, the tumour cell is able to evade the effector immune response (1). Monoclonal antibodies (mAbs) directed against inhibitory co-stimulatory molecules such as Programmed-cell death 1 (PD-1) and cytotoxic T lymphocyte antigen 4 (CTLA-4) or their ligand Programmed-cell death ligand 1 (PD-L1) have been developed to restore effective anti-tumour immunity. These ICIs have led to a major improvement in the prognosis of certain cancers, notably melanoma and non-small cell lung cancer.However, the efficacy of ICIs varies from one cancer to another. In addition to the expression of PDL1 by the tumour and/or immune cells, and the mutational load, one of the primary factors predicting response to immunotherapy mentioned in several studies is microsatellite instability (MSI)., conditionsModule conditions: Colorectal Cancer Metastatic, conditions: Microsatellite Instability-High Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Identification of predictive factors of resistance to pembrolizumab immunotherapy in first-line treatment of unresectable mRCC, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ch - Centre Hospitalier de La Côte Basque, status: NOT_YET_RECRUITING, city: Bayonne CEDEX, zip: 64100, country: France, contacts name: Franck AUDEMAR, Dr, role: CONTACT, phone: +33 5 59 44 37 22, email: faudemar@ch-cotebasque.fr, contacts name: Anne GUILNGAR, Dr, role: CONTACT, phone: +33 5 59 44 37 22, email: aguilngar@ch-cotebasque.fr, contacts name: Franck AUDEMAR, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.48333, lon: -1.48333, locations facility: Ch - Ch Beauvais, status: NOT_YET_RECRUITING, city: Beauvais, country: France, contacts name: Fayçal HOCINE, role: CONTACT, phone: 03 44 11 23 09, email: f.hocine@ch-beauvais.fr ; 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