BRAF V600EPhase 2NCT07506109
A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer
A Phase 2 study testing Ipilimumab N01, Sintilimab and Cetuximab in people with BRAF V600E and Colorectal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BRAF V600E, Colorectal Cancer, Sintilimab
- What is being tested?
- Ipilimumab N01, Sintilimab and Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 4 sitesChina
- Study dates
- 1 Mar 2026to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Not yet recruiting
Peking union medical college hospital
Beijing, Beijing Municipality
Xicheng Wang, Prof., 010-69158370, xicheng_wang@hotmail.com
- Not yet recruiting
West China Hospital Sichuan University
Chengdu, Sichuan
Meng Qiu, MD, 028-85423203, qiumeng33@hotmail.com
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Ting Deng, PhD, +86 18526812877, 18526812877@163.com
- Not yet recruiting
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Zhenyu Lin, 027-85871982, whxhlzy@hust.edu.cn
About this study
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.
- Conditions
- BRAF V600E, Colorectal Cancer, Sintilimab, MSS (Microsatellite Stable), Cetuximab, Dabrafenib
- Being tested
- Ipilimumab N01, Sintilimab, Cetuximab, Dabrafenib
- Medical subject headings
- Colorectal Neoplasms, Spinocerebellar Degenerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipilimumab N01Drug
Also called IBI-310
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.
SintilimabDrug
Also called IBI-308
2mg/kg ivd, q3w
CetuximabDrug
500mg/m2 ivd，q2w
DabrafenibDrug
150mg po bid
| Study group | Role | What they receive |
|---|---|---|
| First-line cohort | Experimental | Ipilimumab N01+Sintilimab+Cetuximab+Dabrafetinib Receives: Drug: Ipilimumab N01; Drug: Sintilimab; Drug: Cetuximab; Drug: Dabrafenib |
| Second-line cohort | Experimental | Ipilimumab N01+Sintilimab+Cetuximab+Dabrafetinib Receives: Drug: Ipilimumab N01; Drug: Sintilimab; Drug: Cetuximab; Drug: Dabrafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from study entry until the first occurrence of disease progression or death from any cause, whichever comes first. If a subject does not experience disease progression during the trial, PFS is defined as the date of the last confirmed progression-free survival assessment for that subject.
Measured: up to 2 years
Secondary outcomes (4)
Disease Control Rate (DCR)
DCR: The percentage of patients with a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) that is maintained for at least 4 weeks, among all patients evaluable for efficacy.
Measured: up to 1 year
Objective Response Rate (ORR)
ORR: The proportion of patients who achieve a reduction in tumor size of a predefined magnitude that is maintained for a specified duration, including cases of CR and PR.
Tumor objective response will be assessed in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. All subjects must have measurable tumor lesions at baseline. Efficacy assessments will be categorized as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) based on RECIST v1.1 criteria.
Measured: up to 1 year
Overall Survival (OS)
OS is defined as the time from study entry to death from any cause. For subjects who are still alive at the final follow-up, OS will be censored at the time of the final follow-up. For lost-to-follow-up subjects, OS will be censored at the time of the last confirmed alive assessment prior to loss to follow-up. OS for censored subjects is defined as the time from study entry to the censoring date.
Measured: up to 3 years
Treatment-Related Adverse Events (TRAE)
Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAEs)
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRAF V600EStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506109
- Sponsor's protocol ID
- SICD-BRAF
- Status last verified
- Dec 2025
- First submitted
- 9 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07506109
- Acronym / sponsor ID
- SICD-BRAF
- Conditions
- BRAF V600E, Colorectal Cancer, Sintilimab, MSS (Microsatellite Stable), Cetuximab, Dabrafenib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First-line cohort | Experimental | Drug: Ipilimumab N01, Drug: Sintilimab, Drug: Cetuximab, Drug: DabrafenibIpilimumab N01+Sintilimab+Cetuximab+Dabrafetinib |
| Second-line cohort | Experimental | Drug: Ipilimumab N01, Drug: Sintilimab, Drug: Cetuximab, Drug: DabrafenibIpilimumab N01+Sintilimab+Cetuximab+Dabrafetinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ipilimumab N01Also: IBI-3101mg/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 | First-line cohort, Second-line cohort |
| SintilimabAlso: IBI-3082mg/kg ivd, q3w | Drug | First-line cohort, Second-line cohort |
| Cetuximab500mg/m2 ivd，q2w | Drug | First-line cohort, Second-line cohort |
| Dabrafenib150mg po bid | Drug | First-line cohort, Second-line cohort |
Primary outcome
Progression-Free Survival (PFS)
Time frame: up to 2 years
PFS is defined as the time from study entry until the first occurrence of disease progression or death from any cause, whichever comes first. If a subject does not experience disease progression during the trial, PFS is defined as the date of the last confirmed progression-free survival assessment for that subject.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab N01, Sintilimab and Cetuximab in people with BRAF V600E and Colorectal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.