NCT07237100

Mirdametinib in Patients With Advanced NF1-mutant Melanoma

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Kevin Kim, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The purpose of this study is to test if mirdametinib is safe and effective in improving disease status and/or delaying progression of disease. Mirdametinib is being studied to see if it can help slow down or stop the growth of certain types of cancer. Mirdametinib is a "MEK inhibitor," which targets specific pathways inside cancer cells. In some cancers, these pathways are overly active, causing the cells to grow and divide quickly. Mirdametinib is designed to block this activity, potentially slowing or stopping cancer growth. Because mirdametinib is a targeted therapy, it focuses on the cancer cells more directly rather than attacking healthy cells throughout the body. This means it may work differently from traditional chemotherapy.

Conditions

• Advanced Unresectable Melanoma
• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Mirdametinib	Mirdametinib is a kinase inhibitor. It is taken by mouth twice a day

Timeline

• Start date: 2025-10-13
• Primary completion: 2027-10-13
• Completion: 2030-10-13
• First posted: 2025-11-19
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study