Actively Recruiting
Mirdametinib in Patients With Advanced NF1-mutant Melanoma
Led by Kevin Kim, MD · Updated on 2025-11-19
10
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Mirdametinib in Patients With Advanced NF1-mutant Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with unresectable or metastatic melanoma with an NF1 mutation confirmed by CLIA-certified lab testing
- Patients previously treated with anti PD-1/PD-L1 antibody and anti CTLA-4 and/or anti LAG3 antibody unless contraindicated
- Tumors must be progressing at enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- 18 years of age or older
- Measurable metastatic disease by RECIST 1.1 criteria
- Adequate organ function including neutrophils, platelets, hemoglobin, kidney, liver, coagulation, and cardiac function within defined limits
- Female patients must be non-childbearing or use effective contraception; male patients or partners must use contraception
- Ability to understand and provide written informed consent
You will not qualify if you...
- Prior treatment with MEK, ERK, or RAF inhibitors
- Symptomatic brain metastases or active brain lesions 6 mm or larger or requiring steroids
- No systemic cancer therapy within 28 days before study drug
- Concurrent enrollment in another therapeutic trial
- Investigational therapy within 4 weeks or less than 5 half-lives before dosing
- History or evidence of retinal pathology posing risk for central serous retinopathy, retinal vein occlusion, or neovascular macular degeneration
- History of glaucoma or significant eye abnormalities
- Clinically significant cardiac disease within 6 months
- Pregnant or breastfeeding
- Active infection requiring antibiotics, antifungals, or antivirals at screening
- Medical conditions or lab abnormalities that may interfere with treatment or study compliance
- Severe acute or chronic medical or psychiatric conditions including recent or active suicidal behavior
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
California Pacific Medical Center - Sutter Health
San Francisco, California, United States, 94115
Actively Recruiting
Research Team
C
Clinical Research at Sutter Health
CONTACT
A
Andrea Davila
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here