drugset / Trial / NCT03180684

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)

NCT03180684

Phase 2 Completed 33 enrolled Inovio Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2017-08-31
Primary completion
2020-07-23
Completion
2020-12-18

Drugs

EvaluationDrugModalityDoseRoute
Subject BIZALIMOGENE RALAPLASMID Vaccine 6 mg Intramuscular
Subject Imiquimod Other / unclassified 5 % Topical