Clinical trial 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)
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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)
Keywords: HPV-16
HPV-18
Lead sponsor: Inovio Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-06-08
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Percentage of Participants With No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Participants With at Least One Local and Systemic Treatment-emergent Adverse Event (TEAE) During 7 Days Following Each Dose
timeFrame: 7 days following each dose: Day 0 (Days 0 to 7), Week 4 (Days 22 to 28), Week 12 (Days 78 to 84), Week 24 (Days 162 to 168), and Week 52 (Days 358 to 364)
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: From baseline up to Week 100
measure: Percentage of Participants With No Histologic Evidence of Vulvar HSIL
timeFrame: Week 48
measure: Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples
timeFrame: Week 48
measure: Percentage of Participants With No Histologic Evidence of Vulvar HSIL or No Evidence of HPV-16/18 in Vulvar Tissue
timeFrame: Week 48
measure: Percentage of Participants With No Evidence of Vulvar HSIL, No Evidence of Vulvar LSIL (VIN1), and No Evidence of Condyloma on Histology
timeFrame: Week 48
measure: Percentage of Participants With No Progression of Vulvar HSIL to Vulvar Cancer
timeFrame: From baseline up to Week 48
measure: Percent Change From Baseline in the Cumulative Surface Area of the Acetowhite Vulvar Lesion(s)
timeFrame: From baseline to Week 48
measure: Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
timeFrame: Baseline; Weeks 15, 27, 48, 74, and 96
measure: Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
timeFrame: Weeks 15, 27, 48, 74, and 96
measure: Change From Baseline in Flow Cytometry Response Magnitude
timeFrame: Baseline; Week 27
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Systems
state: Delaware
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Scarborough
country: United States
facility: Maine Medical Center
state: Maine
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Jackson
country: United States
facility: St. Dominic Hospital
state: Mississippi
city: Newark
country: United States
facility: Rutgers New Jersey
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Columbus
country: United States
facility: Complete HealthCare for Women, Inc.
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Magee Womens Hospital
state: Pennsylvania
city: Chattanooga
country: United States
facility: Chattanooga's Program in Women's Oncology
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Milwaukee
country: United States
facility: Froedtert and The Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Inovio Pharmaceuticals
name: Jeffrey Skolnik, MD
role: STUDY_DIRECTOR
References: