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Recruiting 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

Phase II Interventional BRAF V600E Colorectal Cancer Sintilimab MSS (Microsatellite Stable)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ipilimumab N01, Sintilimab, Cetuximab, Dabrafenib.
Who it may be relevant to
Registry conditions: BRAF V600E, Colorectal Cancer, Sintilimab, MSS (Microsatellite Stable). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Ipilimumab N01
    1mg/kg ivd，q6w or 3mg/kg ivd，q12w followed by maintenance therapy with Ipilimumab N01 1 mg/kg ivd, q6w. The specific dosage and administration schedule should be referred to the relevant study design.
  • Drug Sintilimab
    2mg/kg ivd, q3w
  • Drug Cetuximab
    500mg/m2 ivd，q2w
  • Drug Dabrafenib
    150mg po bid

Primary outcome measures

  • Progression-Free Survival (PFS) [Time frame: up to 2 years]
Secondary outcome measures (4)
  • Disease Control Rate (DCR) [Time frame: up to 1 year]
  • Objective Response Rate (ORR) [Time frame: up to 1 year]
  • Overall Survival (OS) [Time frame: up to 3 years]
  • Treatment-Related Adverse Events (TRAE) [Time frame: up to 3 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).
  • 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.
  • Pregnant or breastfeeding females.
  • The investigator deems the patient unsuitable for participation in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 4 centers
  • Peking union medical college hospital — Beijing
  • Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and — Wuhan
  • West China Hospital Sichuan University — Chengdu
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT07506109 · SICD-BRAF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗