Actively Recruiting
A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-04-07
49
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Age 18 years or older
- Histologically or pathologically confirmed colorectal adenocarcinoma
- Microsatellite stable (MSS) and BRAF V600E mutation confirmed by genomic testing
- Locally advanced unresectable disease or distant metastasis
- No prior treatment with BRAF/MEK/ERK inhibitors, EGFR inhibitors, or immune checkpoint inhibitors
- Presence of measurable target lesions per RECIST 1.1
- ECOG performance status score of 0 or 1
- Adequate organ function with specified laboratory values within 7 days before treatment
- Willing and able to follow study procedures and visit schedule
You will not qualify if you...
- Received systemic anti-tumor therapy within 4 weeks before enrollment
- Underwent surgery or invasive procedure within 4 weeks before study start (exceptions for catheter placement and drainage)
- Multiple primary cancers except certain resected or remission cancers
- Severe comorbidities or serious medical conditions
- Pregnant or breastfeeding women
- Deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or discontinuation
Participants receive a combination of Sintilimab, Ipilimumab N01, Cetuximab, and Dabrafenib as study drugs according to specified dosing schedules.
Visits every 2 to 6 weeks according to drug administration schedules
Duration - Up to 3 years
Participants are monitored for survival and treatment-related adverse events after treatment ends.
Periodic visits during follow-up
Trial Site Locations
Total: 4 locations
1
Peking union medical college hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
3
West China Hospital Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
4
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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