About this trial
This trial looks at two different treatment options for patients with a type of skin cancer called melanoma that has spread to the brain. One treatment combines three medicines, while the other uses two. The goal is to see which combination works better at shrinking tumors and controlling growth in the brain.
This is a Phase 2 trial, which means it is looking at how well the treatments work and how safe they are. The trial is regulated by the FDA and aims to include about 112 participants.
Who can join
The trial is for adults aged 18 and older, both men and women. Participants must have melanoma that has spread to the brain and have a specific mutation called BRAF-V600. Some other health conditions may affect eligibility, but the trial team will confirm who can join.
Conditions
Acral Lentiginous Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Malignant Neoplasm in the Brain, Metastatic Melanoma, Metastatic Mucosal Melanoma, Pathologic Stage IV Cutaneous Melanoma AJCC v8
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be placed into one of two groups by chance. One group will receive a combination of three medicines: encorafenib, binimetinib, and nivolumab. The other group will get nivolumab and ipilimumab. Treatments are given for several weeks, and everyone will be followed closely to see how well the treatments work.
Where
This trial is running at 331 locations in the United States. 303 of them are currently recruiting.
Abbott-Northwestern Hospital
Minneapolis, Minnesota
Adena Regional Medical Center
Chillicothe, Ohio
Alaska Breast Care and Surgery LLC
Anchorage, Alaska
Alaska Oncology and Hematology LLC
Anchorage, Alaska
Alaska Women's Cancer Care
Anchorage, Alaska
Anchorage Associates in Radiation Medicine
Anchorage, Alaska
Anchorage Oncology Centre
Anchorage, Alaska
Anchorage Radiation Therapy Center
Anchorage, Alaska
The first 8 of 331 sites are listed here. The registry record has the full list.