NCT04598009 Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma
| NCT ID | NCT04598009 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, San Francisco |
| Condition | Melanoma Stage III |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2021-03-03 |
| Primary Completion | 2026-05-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This phase II trial studies how well binimetinib and imatinib work in treating patients with stage III-IV KIT-mutant melanoma that cannot be removed by surgery (unresectable). Binimetinib and imatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and imatinib may help treat patients with KIT-mutant melanoma.
Eligibility Criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Have histologically or cytologically confirmed melanoma * Have unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines, not amenable to local therapy * Have measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria * Have documentation of KIT-mutant melanoma by Clinical Laboratory Improvement Act (CLIA)-certified testing platform * Participants have progressed on prior standard-of-care therapy, or would be ineligible for or unable to tolerate standard-of-care therapy, in the opinion of the treating Investigator * For participants who have received prior ICI, the following is permitted: * Prior adjuvant or neoadjuvant ICI, if last dose administered at least 4 weeks prior to study drug start * Prior ICI for the treatment of unresectable/metastatic disease, if last dose administered
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