OncoMatch/Clinical Trials/NCT04598009
Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma
Is NCT04598009 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Binimetinib and Imatinib for melanoma stage iii.
Treatment: Binimetinib · Imatinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Required: KIT mutation
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard-of-care therapy
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
Cannot have received: systemic anti-cancer therapies
Has received systemic anti-cancer therapies within 3 weeks of study drug start
Cannot have received: radiation therapy
radiation within 2 weeks
Cannot have received: antibody therapy
antibody therapy within 4 weeks
Cannot have received: investigational agent
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
Lab requirements
Blood counts
Absolute neutrophil count >= 1,500/mcL; Platelets >= 100,000/mcL
Kidney function
Creatinine <= 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) >= 50 mL/min calculated using the Cockcroft-Gault formula
Liver function
Total bilirubin below normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits; AST (SGOT) <= 3 x institutional upper limit of normal; ALT (SGPT) <= 3 x institutional upper limit of normal
Cardiac function
Left ventricular ejection fraction (LVEF) < 50% as determined by MUGA or ECHO [excluded]; Uncontrolled hypertension defined as persistent systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg despite current therapy [excluded]; History of presence of clinically significant cardiac arrhythmias (including resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia) [excluded]; Triplicate average baseline corrected QT (QTc) interval >= 480 msec [excluded]
Absolute neutrophil count >= 1,500/microliter (mcL); Platelets >= 100,000/mcL; Total bilirubin below normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits; AST (SGOT) <= 3 x institutional upper limit of normal; ALT (SGPT) <= 3 x institutional upper limit of normal; Creatinine <= 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) >= 50 mL/min calculated using the Cockcroft-Gault formula; Impaired cardiovascular function or clinically significant cardiovascular disease including, but not limited to, any of the following: ... (see exclusion criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UC San Diego Moores Cancer Center · La Jolla, California
- University of California, San Francisco · San Francisco, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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