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)

Overview

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

Full Title of Study: “A Phase 2, Randomized, Open Label, Efficacy Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™ 2000 Alone or in Combination With Imiquimod, for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Vulva”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2020

Interventions

  • Biological: VGX-3100
    • One milliliter (1 mL) VGX-3100 will be injected IM and delivered by EP using CELLECTRA™ 2000 on Day 0, Week 4, Week 12 and Week 24. A fifth dose and sixth dose of six mg VGX-3100 may be administered IM with EP per the judgment of the Investigator.
  • Drug: Imiquimod 5% cream
    • Participants will apply imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.
  • Device: CELLECTRA™ 2000
    • IM injection of VGX-3100 is followed by EP with the CELLECTRA™ 2000 device.

Arms, Groups and Cohorts

  • Experimental: VGX-3100 + EP
    • Intramuscular (IM) injections with VGX-3100 followed by EP using the CELLECTRA™ 2000 device on Day 0, Week 4, Week 12 and Week 24.
  • Experimental: VGX-3100 + EP + Imiquimod
    • IM injections with VGX-3100 followed by EP using the CELLECTRA™ 2000 device on Day 0, Week 4, Week 12 and Week 24. In addition, participants will apply imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants with No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples
    • Time Frame: At Week 48

Secondary Measures

  • Safety: Percentage of Participants with Adverse Events
    • Time Frame: From baseline to Week 100
  • Percentage of Participants with No Histologic Evidence of Vulvar HSIL
    • Time Frame: At Week 48
  • Percentage of Participants with No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples
    • Time Frame: At Week 48
  • Percentage of Participants with No Evidence of Vulvar HSIL, No Evidence of Vulvar Low Grade Squamous Intraepithelial Lesions (LSIL) (Vulvar Intraepithelial Neoplasia 1 [VIN1]), and No Evidence of Condyloma on Histology
    • Time Frame: At Week 48
  • Percentage of Participants with No Progression of Vulvar HSIL to Vulvar Cancer
    • Time Frame: From baseline to Week 48
  • Percent Reduction from Baseline in the Cumulative Surface Area of the Acetowhite Vulvar Lesion(s)
    • Time Frame: From baseline to Weeks 48, 74 and 96
  • Change from Baseline in Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
    • Time Frame: From baseline to Weeks 15, 27, 48, 74 and 96
  • Change from Baseline in Interferon-Gamma Response Magnitude
    • Time Frame: From baseline to Weeks 15, 27, 48, 74 and 96
  • Change from Baseline in Flow Cytometry Response Magnitude
    • Time Frame: At baseline and Week 27

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Inovio Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Prakash Bhuyan, MD, Study Director, Inovio Pharmaceuticals

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