A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases

This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ipilimumab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. This trial aims to find out which approach is more effective in shrinking and controlling brain metastases from melanoma.

Trial Details

NCT ID

NCT04511013

Phase

PHASE2

Sponsor

SWOG Cancer Research Network

Status

RECRUITING

Cancer Type

Melanoma

Interventions

Binimetinib
Encorafenib
Ipilimumab
Nivolumab

Locations (sample)

Birmingham, Alabama, United States|33.52066,-86.80249
Fairhope, Alabama, United States|30.52297,-87.90333
Mobile, Alabama, United States|30.69436,-88.04305
Anchorage, Alaska, United States|61.21806,-149.90028
Anchorage, Alaska, United States|61.21806,-149.90028

Key Eligibility Criteria

Participants must have histologically and pathologically confirmed melanoma that has metastasized to the brain
Any primary (cutaneous, acral/mucosal, etc) or unknown origin are permitted, except that participants with uveal primary are not eligible
Participants must have BRAF-V600 mutant melanoma documented by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
All participants must have an magnetic resonance imaging (MRI) of the brain within 28 days prior to registration and must have central nervous syst…

For full eligibility, visit ClinicalTrials.gov.

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