Phase II Study of Sintilimab, Ipilimumab N01, Cetuximab, and Dabrafenib for Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer

What this Trial Is About

Colorectal cancer with the BRAF V600E mutation is a serious condition linked to poor outcomes, especially in patients with metastatic disease that is microsatellite stable MSS. This trial explores a new combination of drugs targeting BRAF mutations, EGFR, and immune checkpoints to improve treatment options for these patients. It is an open-label Phase II study focusing on safety and effectiveness. The study evaluates a combination treatment including sintilimab an anti-PD-1 drug, ipilimumab N01 an anti-CTLA-4 drug, cetuximab an anti-EGFR drug, and dabrafenib a BRAF inhibitor. Participants receive these drugs following specific schedules ipilimumab N01 is given intravenously every 6 or 12 weeks with maintenance dosing, sintilimab every 3 weeks, cetuximab every 2 weeks, and dabrafenib orally twice daily. The trial includes both first-line and second-line treatment groups. Participants will be closely monitored throughout the study with assessments including tumor measurements and laboratory tests to evaluate progression-free survival over up to 2 years. Other outcomes include disease control rate, response rate, overall survival, and tracking of treatment-related side effects for up to 3 years. The study starts in March 2026 and continues through June 2028, with visits and evaluations scheduled regularly to track participants response and safety.

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