NCT07506109

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Ipilimumab N01	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.
DRUG	Sintilimab	2mg/kg ivd, q3w
DRUG	Cetuximab	500mg/m2 ivd，q2w
DRUG	Dabrafenib	150mg po bid

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2026-04-01
• Last updated: 2026-04-07

Locations

4 sites across 1 country: China