Encorafenib + Binimetinib Before Surgery for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of two drugs, encorafenib (Braftovi) and binimetinib (Mektovi), before surgery in treating melanoma that has spread to the lymph nodes and carries the BRAF V600 mutation. The researchers aim to determine if these drugs can halt tumor growth by blocking specific enzymes and to use specialized imaging scans to predict the melanoma's response to treatment. Individuals with stage IIIB to IIID melanoma, possessing the BRAF mutation and who have not received certain prior treatments, may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must not use any prohibited medications, including herbal supplements or foods, within one week before joining the trial. It's best to discuss your current medications with the trial team to ensure there are no interactions with the study drugs.
Is there any evidence suggesting that encorafenib and binimetinib are likely to be safe for humans?
Research has shown that using encorafenib and binimetinib together is generally safe and well-tolerated for people with certain types of melanoma. In studies, patients using this combination lived for about 14.9 months on average without their cancer worsening. Specifically, previous patients with BRAF-mutant melanoma, a specific genetic type of skin cancer, demonstrated that this treatment is both effective and safe.
Safety data from these studies indicate that while side effects can occur, they are usually manageable. Common side effects might include fatigue or rash. These findings mean the treatment has been tested in other patients, providing a clear idea of what to expect in terms of safety.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the combination of encorafenib and binimetinib for treating melanoma because it offers a novel approach to tackling the disease. Unlike traditional treatments like surgery alone or chemotherapy, this combo targets specific genetic mutations in melanoma cells, potentially leading to more effective results. Encorafenib and binimetinib work together by inhibiting proteins in the cancer cells that drive tumor growth, which might result in shrinking tumors before surgery and preventing recurrence after. This targeted action not only promises to be more effective but might also reduce some of the side effects associated with broader treatments.
What evidence suggests that encorafenib and binimetinib might be an effective treatment for melanoma?
Research has shown that using encorafenib and binimetinib together effectively treats advanced melanoma, particularly in patients with the BRAF V600 mutation. Studies have found that these drugs help patients live longer without their cancer worsening. For instance, one study found that the cancer did not progress for an average of 5.8 months. Another study showed that this treatment improved the chances of remaining cancer-free for a year in patients with high-risk melanoma. Overall, this treatment works well and usually causes fewer serious side effects compared to using the drugs separately. In this trial, participants will receive encorafenib and binimetinib before and after surgery to evaluate their effectiveness in both neoadjuvant and adjuvant settings.56789
Who Is on the Research Team?
Leslie A Fecher
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
This trial is for adults with stage IIIB-D melanoma that has spread to lymph nodes and have a BRAF V600 mutation. They must be able to take oral meds, lie still for PET/CT scans, use contraception if of childbearing potential, and not have distant metastases or other serious health issues. HIV-positive patients can join if their condition is stable.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Patients receive encorafenib and binimetinib for up to 2 cycles, with PET/CT scans to evaluate response
Surgical Resection
Patients undergo surgery to remove melanoma after neoadjuvant treatment
Adjuvant Treatment
Patients resume treatment with encorafenib and binimetinib for up to 11 cycles post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Binimetinib
- Computed Tomography
- Conventional Surgery
- Encorafenib
- Positron Emission Tomography
Binimetinib is already approved in United States, European Union, Canada, Japan for the following indications:
- Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
- Unresectable or metastatic melanoma with a BRAF V600 mutation
- Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
- Unresectable or metastatic melanoma with a BRAF V600 mutation
Find a Clinic Near You
Who Is Running the Clinical Trial?
ECOG-ACRIN Cancer Research Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator