OncoMatch/Clinical Trials/NCT07237100
Mirdametinib in Patients With Advanced NF1-mutant Melanoma
Is NCT07237100 recruiting? Yes, currently enrolling (May 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
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 →
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