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
| NCT ID | NCT07506109 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | BRAF V600E |
| Study Type | INTERVENTIONAL |
| Enrollment | 49 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 49 participants in total. It began in 2026-03-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Provided written informed consent. 2. Age ≥ 18 years. 3. Histologically or pathologically confirmed colorectal adenocarcinoma. 4. Documented microsatellite stable (MSS) and BRAF V600E mutation by prior genomic testing. 5. Locally advanced unresectable disease or distant metastasis. 6. No prior treatment with BRAF/MEK/ERK inhibitors, EGFR inhibitors, or immune checkpoint inhibitors (ICI). 7. Presence of measurable target lesions per RECIST 1.1. 8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. 9. Adequate organ function, based on the following laboratory values obtained within 7 days prior to Cycle 1 Day 1: 1. Hemoglobin ≥ 9.0 g/dL. 2. Absolute neutrophil count ≥ 1,500/mm³ (≥ 1.5 × 109/L). 3. Platelet count ≥ 80,000/mm³ (≥ 80 × 109/L). 4. Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN). 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN. 6. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min. 10. Willing and able to comply with study procedures and visit schedule. Exclusion Criteria: 1. Received any approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment. 2. Underwent any surgery or invasive procedure within 4 weeks prior to study initiation (exceptions include venous catheter placement and paracentesis/drainage). 3. 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). 4. Presence of severe comorbidities or serious medical conditions. 5. Pregnant or breastfeeding females. 6. The investigator deems the patient unsuitable for participation in this study.
Frequently Asked Questions
Who can join the NCT07506109 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying BRAF V600E. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07506109 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07506109 currently recruiting?
Yes, NCT07506109 is actively recruiting participants. Visit ClinicalTrials.gov or contact Tianjin Medical University Cancer Institute and Hospital to inquire about joining.
Where is the NCT07506109 trial being conducted?
This trial is being conducted at Beijing, China, Wuhan, China, Chengdu, China, Tianjin, China.
Who is sponsoring the NCT07506109 clinical trial?
NCT07506109 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 49 participants.