OncoMatch/Clinical Trials/NCT07237100
Mirdametinib in Patients With Advanced NF1-mutant Melanoma
Is NCT07237100 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Mirdametinib for advanced unresectable melanoma.
Treatment: Mirdametinib — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Melanoma
Biomarker criteria
Required: NF1 mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-PD-1 therapy
Must have been previously treated with anti PD-1/PD-L1 antibody
Must have received: anti-CTLA-4 therapy
AND anti CTLA-4 antibody and/or anti LAG3 antibody
Cannot have received: MEK inhibitor
Patients who were previously treated with MEK...inhibitor therapy
Cannot have received: ERK inhibitor
Patients who were previously treated with...ERK...inhibitor therapy
Cannot have received: RAF inhibitor
Patients who were previously treated with...RAF inhibitor therapy
Lab requirements
Blood counts
ANC ≥ 1,500/μL; Platelets ≥ 100,000/μL; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 1.5 x ULN or CrCl ≥ 30 mL/min (Cockcroft-Gault); eGFR ≥60 mL/min/1.73 m2 (CKD-EPI)
Liver function
Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL); AST/ALT ≤ 3.0 x ULN (≤ 5 x ULN if liver metastases present)
Cardiac function
Systolic BP < 160 mmHg and diastolic BP < 100 mmHg; LVEF ≥ 50% by MUGA or ECHO; No clinically significant ECG waveform abnormalities
Adequate organ function, defined as follows: ANC ≥ 1,500/μL; Platelets ≥ 100,000/μL; Hemoglobin ≥ 9 g/dL; Serum creatinine ≤ 1.5 x ULN or CrCl ≥ 30 mL/min (Cockcroft-Gault); eGFR ≥60 mL/min/1.73 m2 (CKD-EPI); Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL); AST/ALT ≤ 3.0 x ULN (≤ 5 x ULN if liver metastases present); INR ≤ 1.5 × ULN (if on anticoagulant therapy, INR > 1.5 × ULN permitted if stable ≥ 2 weeks); PTT ≤ 1.5 × ULN; Systolic BP < 160 mmHg and diastolic BP < 100 mmHg; LVEF ≥ 50% by MUGA or ECHO; No clinically significant ECG waveform abnormalities; normal serum calcium and phosphate
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- California Pacific Medical Center - Sutter Health · San Francisco, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07237100 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior MEK inhibitor, ERK inhibitor, RAF inhibitor disqualifies patients from enrollment.
Does this trial require NF1?
Yes, NF1 mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages