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This international multi-center study uses a combined targeted therapy for advanced melanoma in adolescents. Specifically, researchers will study the efficacy, side effects and how the body processes a regimen of binimetinib and encorafenib, known respectively by the trade names MEKTOVI® and BRAFTOVI™, at different dosages. Previously, this regimen was approved for adults with unresectable or metastatic melanoma with a BRAF V600 mutation, and this research aims to determine if it can also be effective for younger patients.
Subject to certain exclusion criteria, this study is enrolling participants, ages 12 through 17, who have been diagnosed with skin cancer, defined as locally advanced, unresectable or metastatic melanoma or unknown primary melanoma with the presence of BRAF V600E or V600K mutation.
Males and Females: Ages 12 through 17
In 28-day cycles, participants will take the study drugs orally – twice a day for binimetinib and once a day for encorafenib. Drug dosages may be adjusted during the trial period, based on participant reaction to the drugs. At selected intervals, participants will visit with the study doctors for examinations, testing and imaging. After the medication has stopped, participants will complete follow-up visits every 8 weeks for a year.
Visits: 2 clinical visits for the first month and monthly thereafter
Duration: Participants can remain in the study for as long as there are no adverse side effects.
Study Description at National Institutes of Health
Cancer and Blood Disorder Research
Brittani Seynnaeve, MD, MS
For more information about the study or enrollment, please contact:
Ping DeBlasio, MBA, BSN, RN
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