Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3)
Completed · Phase 2
Conditions studied: Vulvar High Grade Squamous Intraepithelial Lesion (HSIL), Vulvar Dysplasia, Vulvar Intraepithelial Neoplasia (VIN), VIN2, VIN3, Pre-cancerous Lesions of the Vulva, Human Papillomavirus (HPV)
In brief
The purpose of this study is to test the safety and efficacy of an investigational immunotherapy VGX-3100, in combination with a study device, to treat women with vulvar high-grade squamous intraepithelial lesion (HSIL) \[vulval intraepithelial neoplasia 2 or 3 (VIN 2 or VIN 3)\] associated with human papilloma virus (HPV) types 16 and/or 18. VGX-3100 is being assessed as an alternative to surgery with the potential to clear the underlying HPV infection. For more information visit our study website at: www.VINresearchstudy.com
Key facts
- Study ID
- NCT03180684
- Run by
- Inovio Pharmaceuticals
- People needed
- 33
- Starts
- 2017-08-31
- Expected to finish
- 2020-12-18
- Last updated by the study team
- 2023-08-25
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women aged 18 and above;
- Have high grade squamous intraepithelial lesion (HSIL) of the vulva (VIN2 or VIN3) caused by infection with HPV types 16 and/or 18 confirmed at screening visit;
You may not qualify if…
- Biopsy-proven differentiated VIN;
- Any previous treatment for vulvar HSIL within 4 weeks prior to screening;
- Allergy to imiquimod 5% cream or to an inactive ingredient in imiquimod 5% cream;
- Pregnant, breastfeeding or considering becoming pregnant within 6 months following the last dose of investigational product;
- Immunosuppression as a result of underlying illness or treatment;
- Significant acute or chronic medical illness.
Where it is running
- Christiana Care Health Systems — Newark, Delaware, United States
- Augusta University — Augusta, Georgia, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Maine Medical Center — Scarborough, Maine, United States
- University of Michigan — Ann Arbor, Michigan, United States
- St. Dominic Hospital — Jackson, Mississippi, United States
- Rutgers New Jersey — Newark, New Jersey, United States
- Columbia University Medical Center — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Lyndhurst Clinical Research — Winston-Salem, North Carolina, United States
- Complete HealthCare for Women, Inc. — Columbus, Ohio, United States
- University of Pittsburgh Medical Center - Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
- Chattanooga's Program in Women's Oncology — Chattanooga, Tennessee, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Froedtert and The Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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