A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer

Colorectal cancer (CRC) is the second leading cause of cancer-related death globally. BRAF V600E mutations occur in approximately 12% of metastatic CRC (mCRC) patients, conferring an extremely poor prognosis with a median overall survival (OS) of only 11 months for standard chemotherapy. Most BRAF V600E-mutant mCRC are microsatellite stable (MSS) and do not benefit from single-agent PD-1/PD-L1 inhibition. Preclinical and clinical evidence indicates that BRAF inhibition in combination with EGFR blockade can induce DNA damage, trigger a deficient mismatch repair (dMMR) phenotype, and increase t

Trial Details

NCT ID
NCT07506109
Phase
PHASE2
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Ipilimumab N01
  • Sintilimab
  • Cetuximab
  • Dabrafenib
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Wuhan, Hubei, China|30.58333,114.26667
  • Chengdu, Sichuan, China|30.66667,104.06667
  • Tianjin, Tianjin Municipality, China|39.14222,117.17667

Key Eligibility Criteria

  • Provided written informed consent.
  • Age ≥ 18 years.
  • Histologically or pathologically confirmed colorectal adenocarcinoma.
  • Documented microsatellite stable (MSS) and BRAF V600E mutation by prior genomic testing.

For full eligibility, visit ClinicalTrials.gov.

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