[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-neurofibroma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-neurofibroma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100600815","phase-1-feasibility-and-tolerability-of-imlygic-for-the-treatment-of-cutaneous-neurofibromas-in-adults-with-nf1-100600815",false,"NCT07102394","Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1","Inclusion Criteria:\n\n* Males or females age ≥ 18 years who meet the NIH clinical criteria for the diagnosis of NF1\n* 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:\n* Singular lesion surrounded by uninvolved skin measuring ≥ 5 mm in the longest diameter but not larger than 5 cm\n\n  1. Not covered by hair\n  2. There is no skin breakdown in the tumor or the skin around it\n  3. Not located in an area that is prone to irritation or trauma.\n  4. A tumor that has not received other therapies such as electrodessication, laser treatment, or prior resection or biopsy.\n  5. 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.\n  6. Participants must have 6 cNFs that are amenable for excision.\n  7. Participants must be willing to undergo pre- and post-treatment tumor excisions providing fresh tumor tissue; there should be no contraindication for serial biopsies.\n* Karnofsky performance level of ≥ 80%.\n* Adequate organ and bone marrow and other organ function as defined by the following Screening laboratory values:\n\n  1. Absolute neutrophil count ≥ 1,500 cells\u002FµL;\n  2. Platelets ≥ 100 x 103\u002FµL;\n  3. Hemoglobin ≥ 9.5 g\u002FdL;\n  4. Serum albumin ≥ 2.8 g\u002FdL;\n  5. Calculated creatinine clearance at Screening ≥ 60 mL\u002Fmin (by Cockcroft-Gault formula) OR a normal serum creatinine.\n  6. Alanine aminotransferase (ALT) ≤ 2x upper limit of institutional norm\n  7. Total bilirubin value of ≤1.5 x Upper Limit of Normal (ULN) (isolated bilirubin ≥1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%)\n* Participant is willing and able to comply with all aspects of the protocol\n* Ability to understand and willingness to sign written informed consent document(s).\n* 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).\n* 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.\n* 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.\n* 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:\n\n  \\-- Refrain from donating sperm\n* PLUS, either:\n\n  * Be abstinent from heterosexual intercourse and agree to remain abstinent until 90 days after the last study drug treatment; OR\n  * 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:\n* Approved Methods of birth control for this study are:\n\n  * Total abstinence\n  * Male or female sterilization (vasectomy in males or surgical removal of ovaries or uterus in females)\n  * Unsterilized male study participants must use a male condom, and their female partner must use one of the methods below:\n  * Unsterilized female study participants must use one of the following highly effective methods listed below:\n* 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:\n* Combined (estrogen and progestogen containing) hormonal contraceptive that stops the release of eggs from the ovary (oral, intravaginal, or transdermal)\n* Progestogen-only hormonal contraception that stops the release of eggs from the ovary (oral, injectable, implantable)\n* Intrauterine device (IUD)\n* Intrauterine hormone-releasing system (IUS)\n* Bilateral tubal occlusion or bilateral tubal ligation\n\nExclusion Criteria:\n\n* 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.\n* Evidence of immunosuppression for any reason:\n\n  1. Known HIV infection or AIDS\n  2. Acute or chronic active hepatitis B or hepatitis C infection\n  3. Chronic oral or systemic steroid medication use at a dose of \\>10 mg\u002Fday of prednisone or equivalent (steroids with low systemic absorption \\[e.g., triamcinolone hexacetonide\\] is allowed)\n  4. Other signs or symptoms of clinical immune system suppression\n* Open herpetic skin lesions\n* Any anti-herpetic treatment within the last 4 weeks prior to trial participation\n* Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir, valacyclovir, famciclovir, any other antiviral medications), other than intermittent topical use\n* 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.\n* 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.\n* Active optic glioma or other low-grade glioma or plexiform neurofibroma requiring treatment. a. Participants not requiring treatment are eligible.\n* 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\n* Patients with marked baseline prolongation of QT\u002FQTc interval (QTc interval \\>470 msec) must be excluded.\n* Previous treatment with IMLYGIC or treatment with Granulocyte-macrophage colony-stimulating factor (GM-CSF)\n* 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.\n* Pregnant or breastfeeding women may not take study drug.\n* Current enrollment or past participation in any other clinical study (excluding observational studies) within 30 days of the first dose of study treatment.\n* Known sensitivity to the study treatment, or components thereof, or drug or other allergy that, could compromise safety of the subject\n* Participants are excluded if they have severe and\u002For 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.).","ALL","18 Years",{"count":18,"type":19},10,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","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.",[25,26,27,28,29,30],"NF1","Neurofibromatosis","Cutaneous Neurofibroma","Neurofibroma","Von Recklinghausen Disease","Neurofibromas",[25,32,33,34,35,36,37],"neurofibromatosis","cutaneous neurofibroma","IMLYGIC","T-VEC","Neurofibromatosis type 1","neurofibroma","RECRUITING","2026-05-07",{"date":41,"type":42},"2026-05-08","ACTUAL",{"date":44,"type":42},"2026-02-01",{"date":46,"type":19},"2027-12-31",{"name":48,"class":49},"Johns Hopkins University","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":20,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":50},"100528315","phase-1-mirdametinib-monotherapy-in-adults-with-neurofibromatosis-1-nf1-and-cutaneous-neurofibromas-cnf-100528315","NCT06159166","Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF).","A Phase 1\u002F2a Open-label, Multicenter Dose Finding Study to Evaluate the Safety and Anti-tumor Activity of Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF).","Mirda","Inclusion Criteria:\n\n1. Meet the diagnostic criteria for NF12\n2. ≥ 18 years of age\n3. Have a minimum of 24 measurable cNF (2 target areas of ≥6 measurable cNF)\n\n   a. Measurable is defined as: i. non-pedunculated (no stalk) ii. surrounded by uninvolved skin and not adjacent to another cNF lesion iii. measuring ≥ 0.5 cm in the longest diameter and ≥ 0.5 cm in height iv. the 24 cNF must be located in two Target Areas. One target area must be located on the back and must have at least 6 measurable cNF. The second target area can be in any of the following body regions with at least 6 cNF: head and neck; upper extremities; anterior chest wall, anterior abdominal wall; pelvic region\u002Fgluteal region; lower extremities.\n4. Participants must have cNF that meet eligibility criteria located within the two study designated target areas or outside of the target areas amenable to biopsy. If biopsy is taken within the target area there must be a minimum of 6 cNF remaining for long term surveillance after biopsy. Participants must be willing to undergo pre-, and on-treatment tumor biopsies providing fresh tumor tissue; there should be no contraindication for serial biopsy\n5. Karnofsky performance level of ≥ 80%.\n6. Adequate organ and bone marrow function as defined by the following Screening laboratory values:\n\n   1. Absolute neutrophil count ≥ 1500 cells\u002FµL;\n   2. Platelets ≥ 100 x 103\u002FµL;\n   3. Hemoglobin ≥ 9.5 g\u002FdL;\n   4. Serum albumin ≥ 2.8 g\u002FdL;\n   5. Calculated creatinine clearance at Screening ≥ 60 mL\u002Fmin (by Cockcroft-Gault formula) OR a normal serum creatinine.\n7. Participant is willing and able to comply with all aspects of the protocol\n8. Ability to understand and the willingness to sign written informed consent document(s).\n9. Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding during any portion of the study and must use an adequate method to avoid pregnancy during the study period and for 6 months after treatment conclusion and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of 6 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).\n\n   * In order 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.\n   * 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.\n\n     * The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n10. Male participants are eligible to participate if they agree to the following during the treatment period and for at least 90 days after the last dose of study treatment:\n\n    * Refrain from donating sperm\n\nPLUS either:\n\n* Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent until 90 days after the last study drug treatment; OR\n* 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:\n\nApproved Methods of birth control for this study are:\n\n* Total abstinence\n* Male or female sterilization (vasectomy in males or surgical removal of ovaries or uterus in females)\n* Unsterilized male study participants must use a male condom and their female partner must use one of the methods below:\n* Unsterilized female study participants must use one of the following highly effective methods listed below:\n\nAcceptable birth control methods which are considered highly effective if they result in a failure rate of less than 1% per year when used consistently and correctly:\n\n* Combined (estrogen and progestogen containing) hormonal contraceptive that stops the release of eggs from the ovary (oral, intravaginal, or transdermal)\n* Progestogen-only hormonal contraception that stops the release of eggs from the ovary (oral, injectable, implantable)\n* Intrauterine device (IUD)\n* Intrauterine hormone-releasing system (IUS)\n* Bilateral tubal occlusion or bilateral tubal ligation\n\nExclusion Criteria:\n\n1. Participant has a altered screening values:\n\n   1. alanine transaminase (ALT) value of \\> 2.0 x upper limit of normal (ULN);\n   2. total bilirubin value of \\> 1.5 x ULN (isolated bilirubin \\> 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C 35%);\n2. Participant has a history of malignancy associated hypercalcemia;\n3. Participant has an active parathyroid disorder, hyperphosphatemia at Screening (serum phosphorus \\> 1 x ULN), or serum calcium (mg\u002FdL) x serum phosphorus (mg\u002FdL) product \\> 70 at Screening;\n4. Any clinically significant active or known history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones);\n5. Hepatitis serology will be tested at Screening. Participants who are hepatitis B surface antigen (HBsAg) positive or hepatitis C virus (HCV) antibody positive at Screening must not be enrolled until further definite testing with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) titers is \\\u003C 500 IU\u002FmL or HCV ribonucleic acid (RNA) polymerase chain reaction test is negative;\n6. Lymphoma, leukemia, or any malignancy (including malignant glioma or MPNST) within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years;\n7. Breast cancer within the past 3 years;\n8. Active optic glioma or other low-grade glioma requiring treatment with chemotherapy or radiation therapy.\n\n   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 PN (such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study;\n9. Abnormal QT interval corrected by Fridericia's formula (\\> 450 msec for male participants, \\> 470 msec for female participants, or \\> 480 msec for participants with known bundle branch block), calculated from triplicate ECG readings taken approximately 2 to 3 minutes apart and averaged at Screening;\n10. Participant has experienced any of the following within 6 months (24 weeks) of signing informed consent\u002Fassent: clinically significant cardiac disease, myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism;\n11. A recorded LVEF \\\u003C 55% at screening or within 3 years of signing informed consent\u002Fassent, OR has a history of congestive heart failure;\n12. Participants with a history of, or evidence of, retinal pathology on ophthalmologic examination that is considered a risk factor for central serous retinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration. Participants will be excluded from study participation if they have any of the following risk factors for RVO at Screening:\n\n    * Intraocular pressure \\> 21 mmHg;\n    * Serum cholesterol \\> 300 mg\u002FdL;\n    * Serum triglycerides \\> 300 mg\u002FdL;\n    * Hyperglycemia (fasting blood glucose \\> 125 mg\u002FdL or random blood glucose \\> 200 mg\u002FdL);\n    * Hypertension (BP ≥ 140\u002F90 mm Hg)\n13. History of glaucoma;\n14. Known history of a positive human immunodeficiency virus (HIV) antibody test;\n15. Known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of mirdametinib (e.g., gastric bypass, lap band, or other gastric procedures). Delivery of mirdametinib via nasogastric tube or gastrostomy tube is not allowed.\n16. Previously treated with MEK inhibitor including mirdametinib (PD-0325901) and had to stop treatment due to adverse event.\n17. Currently receiving therapy with a MEK inhibitor including mirdametinib (PD-0325901) or treated with a MEK inhibitor in the 12 months prior to prior to first dose of study treatment.\n18. Received radiation therapy within the 6 months prior to prior to first dose of study treatment. Participants who have received radiation to the orbit at any time are excluded.\n19. Pregnant or breastfeeding women may not take study drug.\n20. Current enrollment or past participation in any other clinical study (excluding observational studies) within 28 days of first dose of study treatment.\n21. Known sensitivity to the study treatment, or components thereof, or drug or other allergy that, could compromise safety of the subject\n22. Participant is receiving systemic (oral, inhaled, of IV\u002FSC) or ocular glucocorticoid therapy (with the exception of participants with endocrine deficiencies who are allowed to receive physiologic or stress doses of steroids, if necessary) within 14 days prior to first dose of study treatment;\n23. Participants are excluded if they have severe and\u002For 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.).\n24. Participants is receiving systemic treatment of a pan-cytochrom 450 (CYP) inducers such as rifampin or ritonavir within 14-days prior to first dose of study treatment Drug Development and Drug Interactions",{"count":60,"type":19},24,[22,62],"PHASE2","This is a Phase 1\u002F2a, open-label, non-randomized, multi-dose study of mirdametinib monotherapy in adults with NF1 and cNF.\n\nIn both Phases of the study, participation in the study will comprise three periods: screening, treatment and post-study safety follow-up to be performed at the NF1 and cNF specialty center: Johns Hopkins University.",[25,27,65],"Monotherapy",[67],"Mirdametinib","2026-04-09",{"date":70,"type":42},"2026-04-13",{"date":72,"type":42},"2024-02-12",{"date":74,"type":19},"2028-11-15",{"name":48,"class":49}]