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

Recruiting Phase 2 Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
112 (estimated)
Sponsor
SWOG Cancer Research Network · Research network
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About This Trial
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 inte…
Trial Locations
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Eligibility Criteria
Inclusion 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 B…
Contacts

Catrina Mireles

2106148808

cmireles@swog.org

CONTACT

Dana Sparks

12106148808

dsparks@swog.org

CONTACT