Mirdametinib in Patients With Advanced NF1-mutant Melanoma
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Kevin Kim, MD
- Study ID
- NCT07237100
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Advanced Unresectable Melanoma
- Metastatic Melanoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Mirdametinib — DRUGMirdametinib is a kinase inhibitor. It is taken by mouth twice a day
Study Details
The goal of this clinical trial is to evaluate clinical efficacy of mirdametinib in patients with advanced NF1-mutant melanoma whose disease has progressed while on or after previous immunotherapy. The main questions this study aims to answer are: * To evaluate the feasibility of conducting a prospective single-center clinical trial of mirdametinib in patients with advanced NF1-mutant melanoma whose disease progresses during or after PD-1 antibody-based checkpoint inhibitor therapy. * To evaluate preliminary clinical efficacy of mirdametinib in patients with advanced NF1-mutant melanoma whose disease has progressed while on or after previous immunotherapy * To evaluate the safety profile of mirdametinib in patients with advanced NF1-mutant melanoma
Key Dates
- Start date
- Oct 13, 2025
- Status verified
- Nov 2025
- Primary completion
- Oct 13, 2027
- Completion
- Oct 13, 2030
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: MirdametinibPatients receive mirdametinib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
To evaluate the feasibility of conducting a prospective single-center clinical trial of mirdametinib in patients with advanced NF1-mutant melanoma whose disease progresses during or after PD-1 antibody-based checkpoint inhibitor therapy. [ Time Frame: 12 months ]
Central Contacts
- Clinical Research at Sutter Health415-600-1544
- Andrea Davila
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| California Pacific Medical Center - Sutter Health | San Francisco | California | 94115 | California Pacific Medical Center Research Institute Andrea Davila Kevin Kim, MD (PRINCIPAL_INVESTIGATOR) |
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