Mirdametinib in Patients With Advanced NF1-mutant Melanoma
NCT07237100 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-11-19
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
Conditions
- Advanced Unresectable Melanoma
- Metastatic Melanoma
Interventions
- DRUG
-
Mirdametinib
Mirdametinib is a kinase inhibitor. It is taken by mouth twice a day
Sponsors & Collaborators
-
Kevin Kim, MD
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-13
- Primary Completion
- 2027-10-13
- Completion
- 2030-10-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
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