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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 : Active, not recruiting
First Posted : June 8, 2017
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Inovio Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Vulvar High Grade Squamous Intraepithelial Lesion (HSIL) Vulvar Dysplasia Vulvar Intraepithelial Neoplasia (VIN) VIN2 VIN3 Pre-cancerous Lesions of the Vulva Human Papillomavirus (HPV) Biological: VGX-3100 Drug: Imiquimod 5% cream Device: CELLECTRA™ 2000 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arm Intervention/treatment
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.
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.

Device: CELLECTRA™ 2000
IM injection of VGX-3100 is followed by EP with the CELLECTRA™ 2000 device.

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.
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Safety: Percentage of Participants with Adverse Events [ Time Frame: From baseline to Week 100 ]
  2. Percentage of Participants with No Histologic Evidence of Vulvar HSIL [ Time Frame: At Week 48 ]
  3. Percentage of Participants with No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples [ Time Frame: At Week 48 ]
  4. 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 ]
  5. Percentage of Participants with No Progression of Vulvar HSIL to Vulvar Cancer [ Time Frame: From baseline to Week 48 ]
  6. 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 ]
  7. 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 ]
  8. Change from Baseline in Interferon-Gamma Response Magnitude [ Time Frame: From baseline to Weeks 15, 27, 48, 74 and 96 ]
  9. Change from Baseline in Flow Cytometry Response Magnitude [ Time Frame: At baseline and Week 27 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180684


Locations
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United States, Delaware
Christiana Care Health Systems
Newark, Delaware, United States, 19713
United States, Georgia
Augusta University
Augusta, Georgia, United States, 30912
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maine
Maine Medical Center
Scarborough, Maine, United States, 04074
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Mississippi
St. Dominic Hospital
Jackson, Mississippi, United States, 39216
United States, New Jersey
Rutgers New Jersey
Newark, New Jersey, United States, 07103
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Complete HealthCare for Women, Inc.
Columbus, Ohio, United States, 43231
United States, Pennsylvania
University of Pittsburgh Medical Center - Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, United States, 37403
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2519
United States, Wisconsin
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Inovio Pharmaceuticals
Investigators
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Study Director: Prakash Bhuyan, MD Inovio Pharmaceuticals

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Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03180684     History of Changes
Other Study ID Numbers: HPV-201
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inovio Pharmaceuticals:
HPV-16
HPV-18
Additional relevant MeSH terms:
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Squamous Intraepithelial Lesions of the Cervix
Neoplasms
Uterine Cervical Dysplasia
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers