RecruitingMelanoma Stage IIIMelanoma Stage IV
Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: University of California, San Francisco
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ Has received systemic anti-cancer therapies within 3 weeks of study drug start, radiation within 2 weeks, antibody therapy within 4 weeks
- ✕ Has not recovered from adverse events due to prior anti-cancer therapy to =\< grade 1 or baseline. Note: Stable chronic conditions (grade =\< 2) that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies) are exceptions and may enroll
- ✕ Is currently receiving any other investigational agents or has received an investigational agent within 14 days or within 5 half-lives of investigational agent (whichever is shorter), prior to start of study drugs
- ✕ Inability to swallow and retain study drugs
- ✕ Impairment of gastrointestinal function or disease which may significantly alter the absorption of study drugs (e.g., active ulcerative disease, uncontrolled vomiting or diarrhea, malabsorption syndrome, complete small bowel resection), or recent (=\< 3 months) history of a partial or complete bowel obstruction, or other conditions that will interfere significantly with the absorption of oral drugs
- ✕ Hypersensitivity to binimetinib or any of its excipients
- ✕ Hypersensitivity to imatinib or any of its excipients
- ✕ Concurrent neuromuscular disorder that is associated with elevated creatinine-kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Where it's recruiting
California
La Jolla · San Francisco
Source: ClinicalTrials.gov · NCT04598009 · last updated 2026-06-04