Status:

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

Lead Sponsor:

Tianjin Medical University Cancer Institute and Hospital

Conditions:

BRAF V600E

Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 pr...

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.

Key Trial Info

Start Date :

March 1 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2028

Estimated Enrollment :

49 Patients enrolled

Trial Details

Trial ID

NCT07506109

Start Date

March 1 2026

End Date

June 1 2028

Last Update

April 7 2026

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Peking union medical college hospital

Beijing, Beijing Municipality, China

2

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

3

West China Hospital Sichuan University

Chengdu, Sichuan, China

4

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China