Phase II Trial of Targeted Kinase Fusion Inhibition in Unresectable Stage III/IV BRAF/NRAS Wild-Type Melanoma

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Sponsor: Bayer HealthCare Pharmaceuticals, Inc

Location(s): United States

Description

This is a phase II multi-center prospective basket trial designed to test the hypothesis that targeting specific kinase fusions in metastatic melanoma with pre-specified kinase inhibitors will result in objective tumor shrinkage and durable response. The study design is a 2 stage optimal design with a sample size of N=35, with n1=11 during stage I and n2=24 during stage II. If 1 or fewer responses are observed during stage I, the trial will be stopped. If 6 or fewer responses are observed by the end of stage II, the trial will be stopped.