RecruitingPhase 2NCT07237100

Mirdametinib in Patients With Advanced NF1-mutant Melanoma

A Pilot Study of Mirdametinib in Patients With Advanced Melanoma With an NF1 Mutation


Sponsor

Kevin Kim, MD

Enrollment

10 participants

Start Date

Oct 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called mirdametinib — which targets a specific mutation (NF1) in tumor cells — for people with advanced melanoma (skin cancer that has spread or cannot be removed) that carries an NF1 gene mutation. **You may be eligible if...** - You have unresectable or metastatic melanoma with a confirmed NF1 mutation (tested in a certified lab) - You have previously been treated with standard immunotherapy drugs (anti-PD-1 and anti-CTLA-4), unless they were not appropriate for you - Your cancer is currently growing **You may NOT be eligible if...** - Your NF1 gene change is of unknown significance - You have not received prior immunotherapy (unless it was not clinically suitable) - You are in poor overall health Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

DRUGMirdametinib

Mirdametinib is a kinase inhibitor. It is taken by mouth twice a day


Locations(1)

California Pacific Medical Center - Sutter Health

San Francisco, California, United States

View Full Details on ClinicalTrials.gov

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NCT07237100


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