NCT03180684 - 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) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2017

Primary Completion Date

July 23, 2020

Study Completion Date

December 18, 2020

Conditions

Vulvar High Grade Squamous Intraepithelial Lesion (HSIL)Vulvar DysplasiaVulvar Intraepithelial Neoplasia (VIN)VIN2VIN3Pre-cancerous Lesions of the VulvaHuman 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.

Trial Locations (15)

10032

Columbia University Medical Center, New York

10461

Montefiore Medical Center, The Bronx

15213

University of Pittsburgh Medical Center - Magee Womens Hospital, Pittsburgh

19713

Christiana Care Health Systems, Newark

27103

Lyndhurst Clinical Research, Winston-Salem

30912

Augusta University, Augusta

37403

Chattanooga's Program in Women's Oncology, Chattanooga

39216

St. Dominic Hospital, Jackson

43231

Complete HealthCare for Women, Inc., Columbus

48109

University of Michigan, Ann Arbor

53226

Froedtert and The Medical College of Wisconsin, Milwaukee

60612

Rush University Medical Center, Chicago

04074

Maine Medical Center, Scarborough

07103

Rutgers New Jersey, Newark

37232-2519

Vanderbilt University Medical Center, Nashville