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

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07506109
Phase
PHASE2
Status
Recruiting
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Conditions

  • BRAF V600E
  • Cetuximab
  • Colorectal Cancer
  • Dabrafenib
  • Ipilimumab N01
  • MSS (Microsatellite Stable)
  • Sintilimab

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab N01 — DRUG
    1mg/kg ivd，q6w or 3mg/kg ivd，q12w followed by maintenance therapy with Ipilimumab N01 1 mg/kg ivd, q6w. The specific dosage and administration schedule should be referred to the relevant study design.
  • Sintilimab — DRUG
    2mg/kg ivd, q3w
  • Cetuximab — DRUG
    500mg/m2 ivd，q2w
  • Dabrafenib — DRUG
    150mg po bid

Study Details

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 tumor mutational burden (TMB), thereby sensitizing MSS tumors to immune checkpoint inhibition. This provides a strong rationale for combining BRAF/EGFR inhibitors with anti-PD-1 and anti-CTLA-4 immunotherapy. This is a single-arm, open-label, Phase II clinical trial. The primary objective is to evaluate the efficacy and safety of the triplet combination of sintilimab (anti-PD-1), ipilimumab N01 (anti-CTLA-4), cetuximab (anti-EGFR), and dabrafenib (BRAF inhibitor) in patients with MSS, BRAF V600E-mutant mCRC.

Key Dates

First listed
Apr 1, 2026
Start date
Mar 1, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
49 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: First-line cohort
    Ipilimumab N01+Sintilimab+Cetuximab+Dabrafetinib
  • Experimental: Second-line cohort
    Ipilimumab N01+Sintilimab+Cetuximab+Dabrafetinib

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: up to 2 years ]

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