Encorafenib/Binimetinib/Nivolumab vs Ipilimumab/Nivolumab for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores treatments for melanoma that has spread to the brain. It compares two approaches: one combines encorafenib (a BRAF inhibitor), binimetinib (a MEK inhibitor), and nivolumab (an immunotherapy drug), while the other uses nivolumab and ipilimumab (both immunotherapy drugs). The goal is to determine which treatment better shrinks and controls brain tumors. It suits individuals with BRAF-V600 mutant melanoma that has metastasized to the brain and who have not received prior systemic therapy for their metastatic disease. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have a serious active infection requiring treatment, and you must not be planning to use hormonal contraceptives. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of encorafenib, binimetinib, and nivolumab is generally well-tolerated. In previous studies with patients who have BRAF-mutant melanoma, many continued treatment without major issues, though some experienced side effects. These studies highlighted that while the treatment improved survival rates, monitoring side effects was important.
In contrast, the combination of nivolumab and ipilimumab has been studied for a longer period. A large study found that about half of the patients experienced severe side effects, such as tiredness or skin problems. Despite this, many patients continued with the treatment due to its good long-term results.
Both treatments have shown benefits, but side effects can occur. Participants in a trial will have their health closely monitored by doctors to manage any side effects that might arise.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments in this trial for melanoma because they offer potential new combinations and approaches that differ from standard therapies. The combination of encorafenib, binimetinib, and nivolumab is novel because it integrates targeted therapy with immunotherapy. Encorafenib and binimetinib specifically target the BRAF/MEK pathway, which is often mutated in melanoma, while nivolumab enhances the immune response against cancer cells. Meanwhile, the nivolumab and ipilimumab combination, already a standard practice, is being re-evaluated to see if it can be optimized further. These approaches could lead to more effective and personalized treatment options for melanoma patients.
What evidence suggests that this trial's treatments could be effective for melanoma with brain metastases?
In this trial, participants will receive one of two treatment combinations. Research has shown that the combination of encorafenib, binimetinib, and nivolumab, one of the treatment arms in this trial, can benefit patients with a specific type of melanoma (BRAF V600-mutant) that has spread to the brain. In one study, 36% of patients treated with these drugs were still alive after 18 months. Previous studies also found positive results for patients with melanoma that spread to the brain when treated with encorafenib and binimetinib.
The other treatment arm involves the combination of ipilimumab and nivolumab, which has demonstrated impressive long-term results. Specifically, after 10 years, 96% of patients who were free of disease progression at 3 years were still alive. Both treatment combinations in this trial show promise for managing melanoma that has spread to the brain.24567Who Is on the Research Team?
Zeynep Eroglu
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
This trial is for adults with BRAF-V600 mutant melanoma that has spread to the brain. They must be able to take pills, have a certain level of physical fitness (Zubrod status <=2), and their major organs need to function within specific limits. People with HIV can join if they're on effective therapy. Those who've had other cancers may qualify if it doesn't affect this study's safety or results.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either encorafenib, binimetinib, and nivolumab or nivolumab and ipilimumab. Treatment cycles repeat every 21-28 days depending on the arm, in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 6 months for 2 years, then annually until 3 years after randomization.
What Are the Treatments Tested in This Trial?
Interventions
- Encorafenib, Binimetinib
- Ipilimumab, Nivolumab
Encorafenib, Binimetinib is already approved in United States, European Union for the following indications:
- Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
- Metastatic non-small cell lung cancer with a BRAF V600E mutation
- Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
- Metastatic colorectal cancer with a BRAF V600E mutation
Find a Clinic Near You
Who Is Running the Clinical Trial?
SWOG Cancer Research Network
Lead Sponsor
Southwest Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator