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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mirdametinib — DRUG
    Mirdametinib 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: Mirdametinib
    Patients 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

Locations (1)

FacilityCityStateZIPSite coordinators
California Pacific Medical Center - Sutter HealthSan FranciscoCalifornia94115
California Pacific Medical Center Research Institute
Andrea Davila
Kevin Kim, MD (PRINCIPAL_INVESTIGATOR)

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