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)

Status: Closed to Accrual

Description

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 HSIL (VIN 2 or VIN 3) associated with 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

Eligibility Criteria

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.

Locations & Contacts

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not Available

New York

Bronx
Montefiore Medical Center-Einstein Campus
Status: Active
Name Not Available
New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Inovio Pharmaceuticals

Trial IDs

Primary ID HPV-201
Secondary IDs NCI-2018-00106
Clinicaltrials.gov ID NCT03180684