Actively Recruiting
A Phase II Study of Binimetinib in Combination With Imatinib in Patients With Advanced KIT-Mutant Melanoma
Led by University of California, San Francisco · Updated on 2026-06-04
25
Participants Needed
2
Research Sites
52 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
Researchers are evaluating how well binimetinib combined with imatinib works in treating patients with advanced KIT-mutant melanoma that cannot be removed by surgery, specifically those with stage III-IV disease. This phase II trial aims to assess the overall response rate and further understand the safety, tolerability, and survival outcomes of this drug combination. The study also explores associations between clinical responses and certain biomarkers or genetic factors that might affect treatment resistance. Participants take binimetinib orally twice daily and imatinib once daily in 28-day cycles. Treatment continues as long as the disease does not progress or unacceptable side effects occur. After finishing the treatment period, participants have follow-up visits at 30 and 100 days, then every three months for ongoing monitoring. During the study, participants undergo evaluations to monitor tumor response using standardized criteria up to week 16 and safety assessments for up to two years. Researchers measure treatment-related side effects, duration of response, progression-free survival, overall survival, and clinical benefit rates. Follow-ups continue after treatment to assess long-term outcomes and any late effects of the therapy. Total participation length depends on treatment response and follow-up schedule.
CONDITIONS
Brief 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 0 to 2 (Karnofsky 60% or higher)
- Histologically or cytologically confirmed melanoma
- Unresectable Stage III or Stage IV melanoma not suitable for local therapy
- Measurable disease by RECIST v1.1 criteria
- Documented KIT-mutant melanoma by certified testing
- Progression on prior standard therapy or ineligible/unable to tolerate standard therapy
- Prior immune checkpoint inhibitor therapy allowed if last dose at least 4 weeks before study start
- Absolute neutrophil count of 1,500/microliter or higher
- Platelets of 100,000/microliter or higher
- Total bilirubin below normal limits or within normal limits if Gilbert's syndrome
- AST and ALT levels no more than 3 times the institutional upper limit
- Creatinine ≤1.5 times upper limit or GFR ≥50 mL/min
- HIV-infected individuals on effective therapy with undetectable viral load within 3 months
- Controlled hepatitis B or treated and cured hepatitis C infection
- Patients with brain metastases if no immediate CNS treatment needed
- Prior or concurrent malignancy allowed if not interfering with study
- Women of child-bearing potential and sexually active men must agree to specified contraception measures
- Ability to understand and sign informed consent
- Willingness and ability to comply with study procedures and visits
You will not qualify if you...
- Systemic anti-cancer therapies within 3 weeks, radiation within 2 weeks, or antibody therapy within 4 weeks before study start
- Unresolved adverse events from prior therapy above grade 1 or baseline, except stable chronic conditions
- Current or recent use of other investigational agents within 14 days or 5 half-lives
- Inability to swallow or retain study drugs
- Gastrointestinal disorders affecting drug absorption or recent bowel obstruction
- Allergies to binimetinib, imatinib, or their components
- Neuromuscular disorders linked to elevated creatinine-kinase
- History or risk factors for retinal vein occlusion or retinal degenerative disease
- Significant cardiovascular disease or uncontrolled hypertension
- Use of prohibited medications that cannot be stopped safely
- Patients on warfarin who cannot switch to another anticoagulant
- Recent thromboembolic or cerebrovascular events within 12 weeks
- Pregnant or breastfeeding women
- Other serious medical or psychiatric conditions that increase risk or interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive binimetinib orally twice daily and imatinib orally once daily in repeated 28-day cycles until disease progression or unacceptable toxicity.
Visits occur every 28 days for treatment cycles
Duration - Up to 2 years
Participants are followed up after treatment completion to monitor safety and survival outcomes.
Visits at day 30, day 100, then every 3 months
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
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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