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Pilot Study of Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma
This is a pilot study evaluating the feasibility of using adaptive intermittent dosing of vemurafenib and cobimetinib in BRAF mutant patients with elevated baseline lactate dehydrogenase (LDH). The purpose of this study is to determine whether an intermittent adaptive dosing of vemurafenib and cobimetinib may be superior to standard, continuous dosing with these study drugs.
Primary Objective: Determine feasibility of an adaptive intermittent treatment design, as defined by how many patients successfully reach 16 weeks with the prescribed on/off schedule without progression of disease. Secondary Objectives: Estimate time to treatment failure, defined as the time from the day of first dose of study drugs to the first day of treatment with another regimen or with the same regimen in a non-adaptive fashion. Estimate objective tumor response rate. Assess toxicity and dose delivery, both over the entire course of therapy and on a per day basis. Perform single cell analyses in tumor biopsies and measure BRAF cfDNA in serial plasma samples.