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
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Documented microsatellite stable (MSS) status and BRAF V600E mutation 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
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate organ function based on lab values within 7 days before treatment start, including hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 80,000/mm3, serum total bilirubin ≤ 1.5 × upper limit of normal, AST and ALT ≤ 2.5 × upper limit of normal, and serum creatinine ≤ 1.5 × upper limit of normal or creatinine clearance ≥ 50 mL/min
- Willing and able to comply with study procedures and visit schedule
You will not qualify if you...
- 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 start (except venous catheter placement and paracentesis/drainage)
- Multiple primary malignancies except certain completely resected or in remission cancers
- Presence of severe comorbidities or serious medical conditions
- Pregnant or breastfeeding females
- Investigator considers the patient unsuitable for participation in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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