Phase II Study of Binimetinib and Imatinib Treatment for Unresectable Advanced KIT-Mutant Melanoma

What this Trial Is About

Researchers are evaluating how well binimetinib combined with imatinib works in treating patients with advanced KIT-mutant melanoma that cannot be removed by surgery, specifically those with stage III-IV disease. This phase II trial aims to assess the overall response rate and further understand the safety, tolerability, and survival outcomes of this drug combination. The study also explores associations between clinical responses and certain biomarkers or genetic factors that might affect treatment resistance. Participants take binimetinib orally twice daily and imatinib once daily in 28-day cycles. Treatment continues as long as the disease does not progress or unacceptable side effects occur. After finishing the treatment period, participants have follow-up visits at 30 and 100 days, then every three months for ongoing monitoring. During the study, participants undergo evaluations to monitor tumor response using standardized criteria up to week 16 and safety assessments for up to two years. Researchers measure treatment-related side effects, duration of response, progression-free survival, overall survival, and clinical benefit rates. Follow-ups continue after treatment to assess long-term outcomes and any late effects of the therapy. Total participation length depends on treatment response and follow-up schedule.

Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma