Purpose

The purpose of this study is to investigate the efficacy and safety of VGX-3100 followed by electroporation (EP) with CELLECTRA™ 2000 alone or in combination with imiquimod in participants with human papillomavirus HPV-16 and/or HPV-18 related high grade squamous intraepithelial lesion (HSIL) of the vulva. In this study, all eligible participants will receive four to six doses of VGX-3100 or VGX-3100 administration in combination with imiquimod.

Conditions

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 caused by HPV types 16 or 18 confirmed at screening visit;

Exclusion Criteria

  • Untreated microinvasive or invasive cancer;
  • Biopsy-proven vaginal intraepithelial neoplasia (VAIN), anal intraepithelial neoplasia (AIN), or cervical intraepithelial neoplasia (CIN) and not undergoing medical care and/or treatment;
  • Biopsy-proven differentiated VIN;
  • Treatment for genital warts within 4 weeks prior to screening;
  • 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
Intramuscular (IM) injections with VGX-3100 followed by EP using the CELLECTRA™ 2000 device on Day 0, Week 4, Week 12 and Week 24.
  • 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.
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.
  • 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.

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10461
Contact:
Melissa Hudson
718-405-8214
MEHUDSON@montefiore.org

More Details

NCT ID
NCT03180684
Status
Recruiting
Sponsor
Inovio Pharmaceuticals

Study Contact

Inovio Call Center
(267) 440-4237
clinical.trials@inovio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.