NCT07506109RecruitingPhase 2
A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (estimated)
- First submitted
- 9 Mar 2026
- Start date
- 1 Mar 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07506109
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 49
- From 1 Mar 2026 to the primary completion date, Dec 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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.
Other
- Pregnant or breastfeeding females.
- The investigator deems the patient unsuitable for participation in this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.