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

Melanoma Stage IV Clinical Trial

Official title:
A Phase II Study of Binimetinib in Combination With Imatinib in Patients With Advanced KIT-Mutant Melanoma

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate the overall response rate (ORR) of binimetinib plus imatinib in patients with advanced KIT-mutant melanoma. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of binimetinib plus imatinib in patients with advanced KIT-mutant melanoma. II. To estimate efficacy and survival parameters in patients with advanced KIT-mutant melanoma treated with binimetinib plus imatinib. III. To estimate efficacy in patients with advanced KIT-mutant melanoma treated with binimetinib plus imatinib. EXPLORATORY OBJECTIVES: I. To investigate association between changes in drug phosphorylated end products (p-KIT, p-MEK, p-ERK) and clinical response. II. To investigate association between clinical response and baseline Neurofibromatosis 1 (NF1) and SPRED1 status. III. To investigate pathologic correlates of acquired resistance. IV. To investigate whether NF1 and SPRED1 loss contribute to acquired resistance. V. To generate patient-derived xenograft models. VI. To determine the relationship between clinical outcomes and clinicopathologic features including KIT exon mutated, melanoma subtype, melanoma primary site, race/ethnicity, prior treatment history including immune checkpoint inhibitor (ICI)-experienced versus (vs) - naive. OUTLINE: Patients receive binimetinib orally (PO) twice daily (BID) on days 1-28 and imatinib PO once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at day 30 and 100, and then every 3 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04598009
Study type Interventional
Source University of California, San Francisco
Contact Sonia Contreras Martinez
Phone (415) 514-6427
Email sonia.contrerasmartinez@ucsf.edu
Status Recruiting
Phase Phase 2
Start date March 3, 2021
Completion date March 31, 2026
View Details
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