Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults Wi… (NCT07102394) | Clinical Trial Compass
RecruitingPhase 1
Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1
United States10 participantsStarted 2026-02-01
Plain-language summary
This study is designed to establish the foundation for a new therapy for neurofibromatosis Type I (NF1)-related cutaneous neurofibromas (cNFs) by assessing the feasibility and efficacy of IMLYGIC in adults with NF1 and cNFs who desire local treatment of their cNF due to disfigurement, progression, pain, itching or other concerns. This is a single institutional Phase 1 study with a safety run-in to assess the feasibility and efficacy of IMLYGIC monotherapy in NF1 patients with cNFs. Each 28-day treatment cycle will be defined as intralesional administration of IMLYGIC administered on day 1 and 21 of Cycle 1 and days 7 and 21 for Cycles 2-4 for up to 4 cycles.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Not covered by hair
✓. There is no skin breakdown in the tumor or the skin around it
✓. Not located in an area that is prone to irritation or trauma.
✓. A tumor that has not received other therapies such as electrodessication, laser treatment, or prior resection or biopsy.
✓. Diffusely infiltrating cutaneous neurofibromas, subcutaneous neurofibromas, and plexiform neurofibromas are NOT eligible for treatment as photographic assessments and measurements with calipers or ruler are not possible or reliable.
✓. Participants must have 6 cNFs that are amenable for excision.
✓. Participants must be willing to undergo pre- and post-treatment tumor excisions providing fresh tumor tissue; there should be no contraindication for serial biopsies.
✕. Acute or chronic active hepatitis B or hepatitis C infection
✕. Chronic oral or systemic steroid medication use at a dose of \>10 mg/day of prednisone or equivalent (steroids with low systemic absorption \[e.g., triamcinolone hexacetonide\] is allowed)
✕. Other signs or symptoms of clinical immune system suppression