Encorafenib + Cetuximab + Nivolumab for Colorectal Cancer
Trial Summary
What is the purpose of this trial?
This phase I/II trial studies the best dose and side effects of encorafenib, cetuximab, and nivolumab and how well they work together in treating patients with microsatellite stable, BRAFV600E gene mutated colorectal cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Encorafenib and cetuximab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.Giving encorafenib, cetuximab, and nivolumab may work better in treating patients with colorectal cancer compared to cetuximab alone.
Research Team
Van K. Morris
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
Adults with microsatellite stable, BRAFV600E mutated colorectal cancer that's inoperable or has spread can join. They must be able to take pills, have certain blood and organ function levels, not be pregnant or fathering a child, and agree to use contraception. Exclusions include HIV, hepatitis B/C infection, uncontrolled hypertension, recent live vaccines, certain heart conditions, brain metastases symptoms.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive encorafenib orally once daily, cetuximab intravenously on days 1 and 15, and nivolumab intravenously on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion at 30 and 100 days, at 3 months, and then every 3 months thereafter.
Treatment Details
Interventions
- Cetuximab
- Encorafenib
- Nivolumab
Cetuximab is already approved in United States, European Union for the following indications:
- Locally or regionally advanced squamous cell carcinoma of the head and neck
- Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
- K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
- BRAF V600E mutation-positive metastatic colorectal cancer
- Squamous cell carcinoma of the head and neck
- K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator