IMLYGIC for Cutaneous Neurofibromas in Adults with NF1
This study is looking at a treatment called IMLYGIC for adults with Neurofibromatosis Type 1 (NF1) who have cutaneous neurofibromas (cNFs), which are skin tumors. The goal is to see if IMLYGIC is safe and practical to use for these cNFs, especially if they cause problems like disfigurement or pain. You would receive IMLYGIC injections directly into your cNFs over 4 cycles, for a total of 8 treatments. The study will check how many participants complete all treatments and if there are any serious side effects. To join, you must be at least 18 years old, have at least 8 measurable cNFs, and meet other health requirements. The current recruitment status is unclear.
- Study design
- This is a single-site study with a planned enrollment of 10 participants. It is an interventional study, meaning participants will receive a specific treatment.
- What's involved
- You would receive IMLYGIC injections on specific days over 4 cycles, for a total of 8 treatments. This treatment period lasts about 4 months, and you will have screening visits, physical exams, and blood tests.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess feasibility and tolerability of IMLYGIC for up to 1 year after treatment.
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NCT07102394
Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1
Recruiting
PHASE1Ages 18+InterventionalTreatmentJohns Hopkins UniversityInvestigator-initiated
~10 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Imlygic
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of IMLYGIC as assessed by percentage of participants receiving 4 treatments
Measured over 1 year
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Carlos Romo, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Males or females age ≥ 18 years who meet the NIH clinical criteria for the diagnosis of NF1
Must have ≥8 measureable cNFs. Histologic confirmation of tumor is not necessary in the presence of consistent clinical findings or confirmed genetic testing. A Measurable cNF is defined as a cutaneous lesion that meets these criteria:
Singular lesion surrounded by uninvolved skin measuring ≥ 5 mm in the longest diameter but not larger than 5 cm
Karnofsky performance level of ≥ 80%.
Adequate organ and bone marrow and other organ function as defined by the following Screening laboratory values:
Participant is willing and able to comply with all aspects of the protocol
Ability to understand and willingness to sign written informed consent document(s).
Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding during any portion of the study and must use an adequate method to prevent pregnancy during the study period and for 3 months after treatment conclusion and agree not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of 3 months after last dose of study treatment. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment (see the Approved Methods of birth control listed below).
For a woman to be determined not of childbearing potential, she must have ≥ 12 months of non-therapy-induced amenorrhea or be surgically or medically sterile.
WOCBP must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result at the Baseline visit prior to the first dose of study treatment if the Screening Day serum test was done more than 28 days prior.
Male participants are eligible to participate if agreed to the following during the treatment period and for at least 90 days after the last dose of study treatment:
PLUS, either:
Be abstinent from heterosexual intercourse and agree to remain abstinent until 90 days after the last study drug treatment; OR
Must agree to use a male condom when having sexual intercourse with a WOCBP and their female partner must utilize one the approved methods of birth control below:
Approved Methods of birth control for this study are:
Total abstinence
Male or female sterilization (vasectomy in males or surgical removal of ovaries or uterus in females)
Unsterilized male study participants must use a male condom, and their female partner must use one of the methods below:
Unsterilized female study participants must use one of the following highly effective methods listed below:
Acceptable birth control methods which are considered highly effective if methods result in a failure rate of less than 1% per year when used consistently and correctly:
Combined (estrogen and progestogen containing) hormonal contraceptive that stops the release of eggs from the ovary (oral, intravaginal, or transdermal)
Progestogen-only hormonal contraception that stops the release of eggs from the ovary (oral, injectable, implantable)
Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion or bilateral tubal ligation
Exclusion
Any underlying medical condition, which in the opinion of the investigator, would make administration of the study drug hazardous or make it difficult to monitor adverse effects.
Evidence of immunosuppression for any reason:
Open herpetic skin lesions
Any anti-herpetic treatment within the last 4 weeks prior to trial participation
Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir, valacyclovir, famciclovir, any other antiviral medications), other than intermittent topical use
One year since the last treatment for any cancer, and not requiring any ongoing secondary prevention, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
Patients who have had chemotherapy or radiation therapy must have recovered normal organ function as defined above; people who had excisions of basal cell or squamous cell carcinoma, must have healed and the scars must be at least 3 cm away from any cNF being monitored or treated.
Active optic glioma or other low-grade glioma or plexiform neurofibroma requiring treatment. a. Participants not requiring treatment are eligible.
Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor or strabismus) or long-standing orbito-temporal Plexiform Neurofibroma (PN) (such as visual loss, strabismus) are eligible
Patients with marked baseline prolongation of QT/QTc interval (QTc interval \>470 msec) must be excluded.
Previous treatment with IMLYGIC or treatment with Granulocyte-macrophage colony-stimulating factor (GM-CSF)
Currently receiving therapy with a Mitogen-Activated Protein Kinase (MEK) inhibitor or treated with a MEK inhibitor in the 6 months prior to the first dose of study treatment.
Pregnant or breastfeeding women may not take study drug.
Current enrollment or past participation in any other clinical study (excluding observational studies) within 30 days of the first dose of study treatment.
Known sensitivity to the study treatment, or components thereof, or drug or other allergy that, could compromise safety of the subject
Participants are excluded if they have severe and/or uncontrolled medical disease or social situation, which could compromise participation in the study (e.g., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper GI tract ulceration, congestive heart failure, drug or alcohol dependence, etc.).
What this trial measures
- Feasibility of IMLYGIC as assessed by percentage of participants receiving 4 treatments1 year
Feasibility is defined as ≥80% of participants receiving 4 treatments
- Tolerability of IMLYGIC as assessed by participants without Dose Limiting Toxicity (DLT) or Serious Adverse Event (SAE)1 year
Tolerability is defined as no participants have a DLT or SAE