Description:
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 HSIL
(VIN 2 or VIN 3) associated with 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
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
HPV-201
- NCT ID:
NCT03180684
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
Drug | Synonyms | Arms |
---|
VGX-3100 | | VGX-3100 + EP |
Imiquimod 5% cream | | VGX-3100 + EP + Imiquimod |
Purpose
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 HSIL
(VIN 2 or VIN 3) associated with 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
Trial Arms
Name | Type | Description | Interventions |
---|
VGX-3100 + EP | Experimental | Intramuscular (IM) injections with VGX-3100 followed by EP using the CELLECTRA™ 2000 device on Day 0, Week 4, Week 12 and Week 24. | |
VGX-3100 + EP + Imiquimod | Experimental | 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. | - VGX-3100
- Imiquimod 5% cream
|
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
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 |
Time Frame: | At Week 48 |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Safety: Percentage of Participants with Adverse Events |
Time Frame: | From baseline to Week 100 |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants with No Histologic Evidence of Vulvar HSIL |
Time Frame: | At Week 48 |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants with No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples |
Time Frame: | At Week 48 |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants with No Evidence of Vulvar HSIL, No Evidence of Vulvar Low Grade Squamous Intraepithelial Lesions (LSIL) (Vulvar Intraepithelial Neoplasia 1 [VIN1]), and No Evidence of Condyloma on Histology |
Time Frame: | At Week 48 |
Safety Issue: | |
Description: | |
Measure: | Percentage of Participants with No Progression of Vulvar HSIL to Vulvar Cancer |
Time Frame: | From baseline to Week 48 |
Safety Issue: | |
Description: | |
Measure: | Percent Reduction from Baseline in the Cumulative Surface Area of the Acetowhite Vulvar Lesion(s) |
Time Frame: | From baseline to Weeks 48, 74 and 96 |
Safety Issue: | |
Description: | |
Measure: | Change from Baseline in Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations |
Time Frame: | From baseline to Weeks 15, 27, 48, 74 and 96 |
Safety Issue: | |
Description: | |
Measure: | Change from Baseline in Interferon-Gamma Response Magnitude |
Time Frame: | From baseline to Weeks 15, 27, 48, 74 and 96 |
Safety Issue: | |
Description: | |
Measure: | Change from Baseline in Flow Cytometry Response Magnitude |
Time Frame: | At baseline and Week 27 |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Inovio Pharmaceuticals |
Trial Keywords
Last Updated
July 27, 2021