A Pilot Study of Mirdametinib in Patients With Advanced Melanoma With an NF1 Mutation
Kevin Kim, MD
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
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 can…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with unresectable or metastatic melanoma with an NF1 mutation; Variance of NF1 of unknown/ uncertain significance will not be eligible; The genetic analysis for somatic mutations must be performed in a lab that has obtained CLIA certification. * Patients must have a report of NF1 sequencing analysis performed at CLIA-certified laboratory (by either tissue-based sequencing or liquid biopsy) * Must have been previously treated with * anti PD-1/PD-L1 antibody; AND anti CTLA-4 antibody and/or anti LAG3 antibody; * UNLESS these standard checkpoint inhibitors are…
Interventions
- DrugMirdametinib
Mirdametinib is a kinase inhibitor. It is taken by mouth twice a day
Location
- California Pacific Medical Center - Sutter HealthSan Francisco, California