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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-08-25

Study results available
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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

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)

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Skolnik, MD · Inovio Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2020-07-23
Completion
2020-12-18
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03180684 on ClinicalTrials.gov