Phase 2
N=33
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)
Vulvar High Grade Squamous Intraepithelial Lesion (HSIL) · Vulvar Dysplasia · Vulvar Intraepithelial Neoplasia (VIN) · VIN2 · VIN3
Bottom Line
View on ClinicalTrials.gov: NCT03180684 ↗Enrolled (actual)
33
Serious AEs
9.1%
Results posted
Aug 2023
Primary outcome: Primary: Percentage of Participants With No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples — 15.0; 37.5 percentage of participants — p=0.0071
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VGX-3100 (Biological); Imiquimod 5% Cream (Drug); CELLECTRA™ 2000 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Inovio Pharmaceuticals
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples |
15.0; 37.5 | 0.0071 sig |
| SECONDARY Percentage of Participants With at Least One Local and Systemic Treatment-emergent Adverse Event (TEAE) During 7 Days Following Each Dose |
84.0; 75.0 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
92.0; 100 | — |
| SECONDARY Percentage of Participants With No Histologic Evidence of Vulvar HSIL |
15.0; 37.5 | — |
| SECONDARY Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples |
15.0; 50.0 | — |
| SECONDARY Percentage of Participants With No Histologic Evidence of Vulvar HSIL or No Evidence of HPV-16/18 in Vulvar Tissue |
15.0; 50.0 | — |
| SECONDARY Percentage of Participants With No Evidence of Vulvar HSIL, No Evidence of Vulvar LSIL (VIN1), and No Evidence of Condyloma on Histology |
10.0; 37.5 | — |
| SECONDARY Percentage of Participants With No Progression of Vulvar HSIL to Vulvar Cancer |
100.0; 100.0 | — |
| SECONDARY Percent Change From Baseline in the Cumulative Surface Area of the Acetowhite Vulvar Lesion(s) |
47.7; 10.5 | — |
| SECONDARY Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude |
1.667; 1.667; 0.833; 0.000; 0.833; 3.333 | — |
| SECONDARY Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations |
7.3; 13.1; 9.6; 15.0; 15.9; 17.2 | — |
| SECONDARY Change From Baseline in Flow Cytometry Response Magnitude |
0.150; 1.250; 0.000; 0.000 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03180684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.