Sintilimab + ipilimumab N01 with cetuximab and dabrafenib for MSS BRAF V600E metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label Phase II trial testing a four-drug combination of sintilimab (anti-PD-1), ipilimumab N01 (anti-CTLA-4), cetuximab (EGFR inhibitor) and dabrafenib (BRAF inhibitor) in patients with MSS, BRAF V600E-mutated metastatic colorectal cancer. The rationale is that BRAF and EGFR blockade can induce DNA damage and raise tumor mutational burden, potentially making MSS tumors more responsive to immune checkpoint blockade. Eligible patients are adults with unresectable or metastatic colorectal adenocarcinoma that is MSS and BRAF V600E-mutant, with ECOG 0–1 and measurable disease, and no prior BRAF/EGFR/immune checkpoint therapy. The primary goals are to measure anti-tumor activity and safety of this combination at participating centers in China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting
• Peking union medical college hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Not yet recruiting
• West China Hospital Sichuan University
  Chengdu, Sichuan, China Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.