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)

NCT ID: NCT03180684

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2020-12-18

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

VGX-3100

Intervention Type: BIOLOGICAL

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.

CELLECTRA™ 2000

Intervention Type: DEVICE

IM injection of VGX-3100 was followed by EP with the CELLECTRA™ 2000 device.

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.

Group Type: EXPERIMENTAL

VGX-3100

Intervention Type: BIOLOGICAL

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.

Imiquimod 5% Cream

Intervention Type: DRUG

Participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.

CELLECTRA™ 2000

Intervention Type: DEVICE

IM injection of VGX-3100 was followed by EP with the CELLECTRA™ 2000 device.

Interventions

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.

Intervention Type: BIOLOGICAL

Imiquimod 5% Cream

Participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.

Intervention Type: DRUG

CELLECTRA™ 2000

IM injection of VGX-3100 was followed by EP with the CELLECTRA™ 2000 device.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Inovio Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Skolnik, MD

Role: STUDY_DIRECTOR

Inovio Pharmaceuticals

Locations

Christiana Care Health Systems

Newark, Delaware, United States

Augusta University

Augusta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Maine Medical Center

Scarborough, Maine, United States

University of Michigan

Ann Arbor, Michigan, United States

St. Dominic Hospital

Jackson, Mississippi, United States

Rutgers New Jersey

Newark, New Jersey, United States

Columbia University Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Lyndhurst Clinical Research

Winston-Salem, North Carolina, United States

Complete HealthCare for Women, Inc.

Columbus, Ohio, United States

University of Pittsburgh Medical Center - Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Chattanooga's Program in Women's Oncology

Chattanooga, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

HPV-201

Identifier Type: -

Identifier Source: org_study_id