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NCT06353854: CORESIM
Prospective National Cohort Evaluating Predictive Biomarkers of Resistance to Immunotherapy in Patients With MSI/dMMR Metastatic Colorectal Cancer (CORESIM)
trial in Colorectal Cancer Metastatic in 600 participants. Currently enrolling.
12 February 2029
Quick facts
| Lead sponsor | Federation Francophone de Cancerologie Digestive |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 600 |
| Start date | 12 February 2024 |
| Primary completion | 12 February 2029 |
| Estimated completion | 12 February 2030 |
| Sites | 20 locations across France |
Conditions studied
- Colorectal Cancer Metastatic — all drugs for Colorectal Cancer Metastatic →
- Microsatellite Instability-High Colorectal Cancer — all drugs for Microsatellite Instability-High Colorectal Cancer →
Sponsor
Federation Francophone de Cancerologie Digestive — full company profile →
Who can join
18 and older, any sex, with Colorectal Cancer Metastatic or Microsatellite Instability-High Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06353854
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Federation Francophone de Cancerologie Digestive trials
Trials by the same sponsor.
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- NCT07128290 — PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma · Phase 2 · not yet recruiting
- NCT07124884 — 5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non- · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06353854 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federation Francophone de Cancerologie Digestive
- Last refreshed: 6 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06353854.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing