RecruitingPhase 2

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

China49 participantsStarted 2026-03-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion 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.
✓. Locally advanced unresectable disease or distant metastasis.
✓. No prior treatment with BRAF/MEK/ERK inhibitors, EGFR inhibitors, or immune checkpoint inhibitors (ICI).
✓. Presence of measurable target lesions per RECIST 1.1.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.

Exclusion criteria

✕. Received any approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment.
✕. Underwent any surgery or invasive procedure within 4 weeks prior to study initiation (exceptions include venous catheter placement and paracentesis/drainage).

What they're measuring

Progression-Free Survival (PFS)

Timeframe: up to 2 years

Trial details

NCT IDNCT07506109

SponsorTianjin Medical University Cancer Institute and Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

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