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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)

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ClinicalTrials.gov Identifier: NCT03180684
Recruitment Status : Completed
First Posted : June 8, 2017
Last Update Posted : December 8, 2021
Sponsor:
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 6, 2017
First Posted Date  ICMJE June 8, 2017
Last Update Posted Date December 8, 2021
Actual Study Start Date  ICMJE June 26, 2017
Actual Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2017)
Percentage of Participants with No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples at Week 48 [ Time Frame: At Week 48 ]
Participants will be evaluated for evidence of vulvar HSIL on histology as well as evidence of HPV-16 and/or HPV-18 in vulvar tissue samples by type-specific HPV testing at the Week 48 visit.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • Safety: Percentage of Participants with Adverse Events [ Time Frame: From baseline to Week 100 ]
  • Percentage of Participants with No Histologic Evidence of Vulvar HSIL [ Time Frame: At Week 48 ]
  • Percentage of Participants with No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples [ Time Frame: At Week 48 ]
  • 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 ]
  • Percentage of Participants with No Progression of Vulvar HSIL to Vulvar Cancer [ Time Frame: From baseline to Week 48 ]
  • 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 ]
  • 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 ]
  • Change from Baseline in Interferon-Gamma Response Magnitude [ Time Frame: From baseline to Weeks 15, 27, 48, 74 and 96 ]
  • Change from Baseline in Flow Cytometry Response Magnitude [ Time Frame: At baseline and Week 27 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2017)
  • Safety: Percentage of Participants with Adverse Events [ Time Frame: From baseline to Week 100 ]
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
  • Percentage of Participants with No Histologic Evidence of Vulvar HSIL at Week 48 [ Time Frame: At Week 48 ]
    Participants will be evaluated for evidence of vulvar HSIL within the boundaries of the original lesion or excisional treatment for histopathologic evaluation on histology at Week 48.
  • Percentage of Participants with No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples at Week 48 [ Time Frame: At Week 48 ]
    Participants will be evaluated for evidence of HPV-16 and/or HPV-18 in vulvar tissue samples by type-specific HPV testing at the Week 48 visit.
  • Percentage of Participants with No Evidence of Vulvar HSIL and No Evidence of Condyloma on Histology at Week 48 [ Time Frame: At Week 48 ]
    Participants will be evaluated for evidence of vulvar HSIL and as well as evidence of condyloma (external genital and perianal warts) on histology at the Week 48 visit.
  • Percentage of Participants with No Progression of Vulvar HSIL to Vulvar Cancer from Baseline to Week 48 [ Time Frame: From baseline to Week 48 ]
    Participants will be evaluated for evidence of vulvar cancer on histology at the Week 48 visit.
  • Percent Reduction from Baseline in the Cumulative Surface Area of the Acetowhite Vulvar Lesion(s) at Weeks 48, 74 and 96 [ Time Frame: From baseline to Weeks 48, 74 and 96 ]
    Participants will be evaluated for percent reduction in the cumulative surface area of the acetowhite vulvar lesion(s) as determined by the quantitative analysis of standardized photographic imaging at Weeks 48, 74 and 96 compared to baseline.
  • 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 ]
    Levels of anti-HPV-16 and anti-HPV-18 antibody concentrations will be measured in serum samples of participants using standardized binding enzyme-linked immunosorbent assay (ELISA) at baseline, Weeks 15, 27, 48, 74, and 96.
  • Change from Baseline in Interferon-Gamma Response Magnitude [ Time Frame: From baseline to Weeks 15, 27, 48, 74 and 96 ]
    Peripheral blood mononuclear cells (PBMCs) will be isolated from whole blood samples collected at baseline, Weeks 15, 27, 48, 74 and 96 to assess cellular immunity.
  • Change from Baseline in Flow Cytometry Response Magnitude [ Time Frame: At baseline and Week 27 ]
    Assessment of cellular immune activity will be evaluated via the application Flow Cytometry for the purposes of performing a Lytic Granule Loading Assay.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vulvar High Grade Squamous Intraepithelial Lesion (HSIL)
  • Vulvar Dysplasia
  • Vulvar Intraepithelial Neoplasia (VIN)
  • VIN2
  • VIN3
  • Pre-cancerous Lesions of the Vulva
  • Human Papillomavirus (HPV)
Intervention  ICMJE
  • Biological: VGX-3100
    One milliliter (1 mL) VGX-3100 will be injected IM and delivered by EP using CELLECTRA™ 2000 on Day 0, Week 4, Week 12 and Week 24. A fifth dose and sixth dose of six mg VGX-3100 may be administered IM with EP per the judgment of the Investigator.
  • Drug: Imiquimod 5% cream
    Participants will apply imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.
  • Device: CELLECTRA™ 2000
    IM injection of VGX-3100 is followed by EP with the CELLECTRA™ 2000 device.
Study Arms  ICMJE
  • Experimental: VGX-3100 + EP
    Intramuscular (IM) injections with VGX-3100 followed by EP using the CELLECTRA™ 2000 device on Day 0, Week 4, Week 12 and Week 24.
    Interventions:
    • Biological: VGX-3100
    • Device: CELLECTRA™ 2000
  • Experimental: VGX-3100 + EP + Imiquimod
    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.
    Interventions:
    • Biological: VGX-3100
    • Drug: Imiquimod 5% cream
    • Device: CELLECTRA™ 2000
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2020)
33
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2017)
36
Actual Study Completion Date  ICMJE December 18, 2020
Actual Primary Completion Date July 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT03180684
Other Study ID Numbers  ICMJE HPV-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Inovio Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Inovio Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jeffrey Skolnik, MD Inovio Pharmaceuticals
PRS Account Inovio Pharmaceuticals
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP