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)

Purpose

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

Conditions

  • Vulvar High Grade Squamous Intraepithelial Lesion (HSIL)
  • Vulvar Dysplasia
  • Vulvar Intraepithelial Neoplasia (VIN)
  • VIN2
  • VIN3
  • Pre-cancerous Lesions of the Vulva
  • Human Papillomavirus (HPV)

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VGX-3100 + EP 		Participants with histologically confirmed vulvar high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV) 16 and/or 18, received four doses of 6 mg VGX-3100 as an intramuscular (IM) injection on Day 0, Week 4, Week 12, and Week 24 followed by electroporation (EP) using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52.
  • Biological: VGX-3100
    One milliliter (1 mL) VGX-3100 injected IM and delivered by EP using CELLECTRA™ 2000 on Day 0, Week 4, Week 12 and Week 24.
  • Drug: Imiquimod 5% Cream
    Participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.
  • Device: CELLECTRA™ 2000
    IM injection of VGX-3100 was followed by EP with the CELLECTRA™ 2000 device.
Experimental
VGX-3100 + EP + Imiquimod 		Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52. In addition, participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.
  • Biological: VGX-3100
    One milliliter (1 mL) VGX-3100 injected IM and delivered by EP using CELLECTRA™ 2000 on Day 0, Week 4, Week 12 and Week 24.
  • Drug: Imiquimod 5% Cream
    Participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.
  • Device: CELLECTRA™ 2000
    IM injection of VGX-3100 was followed by EP with the CELLECTRA™ 2000 device.

More Details

Status
Completed
Sponsor
Inovio Pharmaceuticals

Study Contact