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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)

NCT03180684

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

Related Conditions:
  • Vulvar Neoplasm
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
VGX-3100VGX-3100 + EP
Imiquimod 5% creamVGX-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

NameTypeDescriptionInterventions
VGX-3100 + EPExperimentalIntramuscular (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
VGX-3100 + EP + ImiquimodExperimentalIM 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:Recruiting
Lead Sponsor:Inovio Pharmaceuticals

Trial Keywords

  • HPV-16
  • HPV-18

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