CompletedPhase 2

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)

United States33 participantsStarted 2017-08-31

Plain-language summary

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

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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; Exclusion Criteria: * 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.

What they're measuring

Percentage of Participants With No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples

Timeframe: Week 48

Trial details

NCT IDNCT03180684

SponsorInovio Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-23

Results submitted2023-07-14

View on ClinicalTrials.gov More Vulvar High Grade Squamous Intraepithelial Lesion (HSIL) trials