Actively Recruiting
Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma
Led by University of California, San Francisco · Updated on 2025-09-03
25
Participants Needed
2
Research Sites
325 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
A
Array BioPharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky score at least 60%)
- Histologically or cytologically confirmed melanoma
- Unresectable Stage III or Stage IV melanoma not suitable for local therapy
- Measurable disease according to RECIST v1.1 criteria
- Confirmed KIT-mutant melanoma by CLIA-certified testing
- Progressed on or ineligible for standard-of-care therapy according to investigator
- Prior immune checkpoint inhibitor therapy allowed if last dose was at least 4 weeks before starting study drugs
- Absolute neutrophil count at least 1,500/mcL
- Platelet count at least 100,000/mcL
- Total bilirubin below institutional normal limits unless due to Gilbert's syndrome with normal direct bilirubin
- AST (SGOT) no more than 3 times the institutional upper limit of normal
- ALT (SGPT) no more than 3 times the institutional upper limit of normal
- Creatinine no more than 1.5 times institutional normal limit or creatinine clearance GFR at least 50 mL/min
- HIV-positive individuals on effective antiretroviral therapy with undetectable viral load within 3 months
- Chronic hepatitis B infection with undetectable viral load on suppressive therapy
- Treated and cured hepatitis C infection or undetectable viral load if currently on treatment
- Patients with new or progressive brain metastases eligible if no immediate CNS treatment needed
- Prior or concurrent malignancy allowed if it does not interfere with study treatment or results
- Women of child-bearing potential must use highly effective contraception and avoid egg donation during and 30 days after treatment
- Sexually active men must use condoms and avoid sperm donation during and 90 days after treatment
- Ability to understand and sign informed consent
- Willingness and ability to comply with study procedures and visits
You will not qualify if you...
- Received systemic anticancer therapy within 3 weeks before study drug start, radiation within 2 weeks, or antibody therapy within 4 weeks
- Not recovered from prior therapy side effects to grade 1 or baseline, except stable chronic conditions grade 2 or less
- Currently receiving or recently received investigational agents within 14 days or 5 half-lives
- Unable to swallow or retain study drugs
- Gastrointestinal conditions affecting drug absorption or recent bowel obstruction
- Allergic to binimetinib, imatinib, or their excipients
- Neuromuscular disorders with elevated creatinine kinase
- History or risk factors for retinal vein occlusion or retinal degenerative disease
- Significant cardiovascular disease or impaired heart function
- Use of prohibited medications not safely discontinued before study
- Patients on warfarin unable to switch to other anticoagulants safely
- Recent thromboembolic or cerebrovascular events within 12 weeks
- Pregnant or breastfeeding women
- Other severe medical or psychiatric conditions that increase risk or affect study results as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
S
Sonia Contreras Martinez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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