A Phase II Study of Binimetinib in Combination With Imatinib in Patients With Advanced KIT-Mutant Melanoma
University of California, San Francisco
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.
Description
PRIMARY OBJECTIVE: I. To evaluate the overall response rate (ORR) of binimetinib plus imatinib in participants with advanced KIT-mutant melanoma. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of binimetinib plus imatinib in participants with advanced KIT-mutant melanoma. II. To estimate efficacy and survival parameters in participants with advanced KIT-mutant melanoma treated with binimetinib plus imatinib. III. To estimate efficacy in participants with advanced KIT-mutant melanoma treated with binimetinib plus imatinib. EXPLORATORY OBJECTIVES: I. To investigate asso…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 t…
Interventions
- DrugBinimetinib
Taken orally (PO) twice a day (BID)
- DrugImatinib
Taken orally (PO) once a day (QD)
Locations (2)
- UC San Diego Moores Cancer CenterLa Jolla, California
- University of California, San FranciscoSan Francisco, California