Trial intelligence / Profile preview

Mirdametinib in Large/Giant Congenital Melanocytic Nevi

NCT07891286Phase 2

Key facts

Status: Not yet recruiting
Start: Jan 2027
Primary completion: Jan 2029
Countries: 1
Sponsor: National Cancer Institute

Drugs: mirdametinib
Conditions: Congenital melanocytic nevus (CMN)

Overview

Phase 2, open-label, single-arm trial of mirdametinib in Congenital melanocytic nevus (CMN), sponsored by National Cancer Institute. Primary endpoint: Objective decreases in the largest diameter of LGCMN at 24 months. Planned start Jan 2027; status: not yet recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Arm 1
Mirdametinib orally twice daily on an intermittent dosing schedule (3 weeks on, 1 week off)

Who it enrols

Patients aged 3-40 with large/giant congenital melanocytic nevi (>20cm) and documented NRAS, BRAF, ALK, NTRK1, or RAF1 mutations/fusions, with adequate organ function and no prior MEK inhibitor therapy.

Endpoints

Primary

Objective decreases in the largest diameter of LGCMN24 months

Secondary

Feasibility of evaluating LGCMN thickness by MRI24 months
Reduction in the number of satellite nevi24 months
Safety of mirdametinib24 months
Improvement of itching QOL measures24 months
Feasibility of evaluating pERK as a pharmacodynamic markerend of treatment
Occurrence of cutaneous or extracutaneous melanoma5 years

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