Mirdametinib to Reduce the Size of Large/Giant Congenital Melanocytic Nevi in Children, Adolescents and Young Adults
Public ClinicalTrials.gov record NCT07891286. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Study to Evaluate the Use of the MEK Inhibitor Mirdametinib to Reduce the Size of Large/Giant Congenital Melanocytic Nevi in Children, Adolescents and Young Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: Large and giant congenital melanocytic nevi (LGCMN) are dark birthmarks (moles). They can grow to 8 inches or more across. People with LGCMN have an increased risk of getting skin cancer or problems with the nervous system. Researchers want to find out if a drug approved for a different use (mirdametinib) can shrink the size of LGCMN. Objective: To test mirdametinib in people with LGCMN. Eligibility: People aged 3 to 40 years with LGCMN. Design: Participants will be screened. Their LGCMN sites will be measured and photographed. They will have blood tests, an eye exam, and tests of their heart function. They will also have: * An exam of their nervous system: Their muscle strength, ability to feel and touch, balance, alertness, and other skills will be tested. * Magnetic resonance imaging (MRI) scan: They will lie on a bed that slides into a tube; the scan will use large magnets to create images of their brain and spinal cord. * Skin biopsy: A small sample of their skin may be taken. * VECTRA scan: This is a 3-dimensional imaging system that takes pictures of all of the skin all at once. Mirdametinib will be either pills or capsules that are taken by mouth. Participants will take the drug in 4-week cycles. They will take the pills 2 times a day for 3 weeks with 1 week off. Participants may continue taking the drug for 2 years. They will have clinic visits 12 times while taking the drug. Imaging scans and other tests will be repeated. Participants will continue to have checkups every 6 months for 3 more years.
Study identification
- NCT ID
- NCT07891286
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 15 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 3 Years to 40 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 4, 2027 (Estimated)
- Primary completion
- Jan 4, 2029 (Estimated)
- Completion
- Jan 4, 2032 (Estimated)
- Last update posted
- Oct 23, 2026
2027 – 2032
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07891286, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 23, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07891286 live on ClinicalTrials.gov.