Encorafenib + Cetuximab + Nivolumab for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of three drugs—encorafenib, cetuximab, and nivolumab—to determine their effectiveness in treating a specific type of colorectal cancer. The focus is on colorectal cancer that cannot be surgically removed or has metastasized, featuring a particular genetic mutation (BRAFV600E) and stable microsatellites (a type of genetic marker). The trial seeks to identify the optimal dose and understand side effects, while assessing whether this drug combination is more effective than current treatments. Suitable participants have previously undergone chemotherapy for colorectal cancer that did not respond well or worsened after treatment. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot take corticosteroids or other immunosuppressive medications while participating, except for low-dose steroid replacement therapy. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of encorafenib, cetuximab, and nivolumab has been tested in patients with a specific type of colorectal cancer. Studies have found this treatment to be quite effective, with patients living for a median of 22 months, which is encouraging for those with this condition.
Most patients have tolerated the treatment well, experiencing no severe side effects. As this trial is in its early stages, the researchers aim to find the best dose and understand possible side effects. These stages involve closely monitoring participants to ensure their safety.
All three drugs in this combination are already used in other treatments, providing some information about their safety. However, each person's experience can differ, so discussing possible side effects with the trial team could be helpful.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of encorafenib, cetuximab, and nivolumab for colorectal cancer because it targets the disease in a novel way. Unlike standard treatments like chemotherapy and radiation, this regimen combines targeted therapy with immunotherapy. Encorafenib inhibits a specific protein in cancer cells, potentially stopping their growth, while cetuximab blocks another protein on cancer cells, preventing them from receiving growth signals. Nivolumab, an immunotherapy, helps the immune system recognize and attack cancer cells. This multi-pronged approach has the potential to be more effective by disrupting cancer growth and boosting the body's natural defenses.
What evidence suggests that this trial's treatments could be effective for colorectal cancer?
Research has shown that using the drugs encorafenib and cetuximab together can slightly improve survival in patients with BRAF-mutated colorectal cancer. These drugs block proteins that cancer cells need to grow. In this trial, participants will receive a combination of encorafenib, cetuximab, and nivolumab. Although adding nivolumab, which boosts the immune system, has not yet proven effective in overcoming resistance in this cancer type, this combination appears promising. More studies are needed to understand how well these drugs work together for colorectal cancer.12467
Who Is on the Research Team?
Van K. Morris
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
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 for a Trial Participant
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.
What Are the Treatments Tested in This Trial?
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