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

Recruiting now · Phase 2

Conditions studied: BRAF V600E, Colorectal Cancer, Sintilimab, MSS (Microsatellite Stable), Cetuximab, Dabrafenib, Ipilimumab N01

In brief

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 facts

Study ID

NCT07506109

Run by

Tianjin Medical University Cancer Institute and Hospital

People needed

49

Starts

2026-03-01

Expected to finish

2028-06-01

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Adequate organ function, based on the following laboratory values obtained within 7 days prior to Cycle 1 Day 1:
• Hemoglobin ≥ 9.0 g/dL.
• Absolute neutrophil count ≥ 1,500/mm³ (≥ 1.5 × 109/L).
• Platelet count ≥ 80,000/mm³ (≥ 80 × 109/L).
• Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN).
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
• Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min.
• Willing and able to comply with study procedures and visit schedule.

You may not qualify if…

• 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).
• Multiple primary malignancies (exceptions include completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or any other cancer that has been in complete remission for at least 3 years).
• Presence of severe comorbidities or serious medical conditions.
• Pregnant or breastfeeding females.
• The investigator deems the patient unsuitable for participation in this study.

Where it is running

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• Peking union medical college hospital — Beijing, Beijing Municipality, China
• Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• West China Hospital Sichuan University — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

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