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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 : Recruiting
First Posted : June 8, 2017
Last Update Posted : September 10, 2018
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

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 : August 2020
Estimated Study Completion Date : September 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


Contacts
Contact: Inovio Call Center (267) 440-4237 clinical.trials@inovio.com
Contact: Website: www.VINresearchstudy.com

  Hide Study Locations
Locations
United States, Florida
Jupiter Medical Center Recruiting
Jupiter, Florida, United States, 33458
Contact: Deia Wilkes    561-263-5768    Deia.Wilkes@jupitermed.com   
Principal Investigator: Donna Pinelli         
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Angela Goebel    706-721-2535    agoebel@augusta.edu   
Principal Investigator: Daron Ferris         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Judith Dybinski    312-942-7254    judithmdybinski@rush.edu   
Principal Investigator: Summer Dewdney         
United States, Kansas
Kansas University Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: John Moore    913-588-6287    jmoore20@kumc.edu   
Principal Investigator: Kevin Ault         
United States, Maine
Maine Medical Center Recruiting
Scarborough, Maine, United States, 04074
Contact    207-396-8670    clinicalresearch@mmc.org   
Principal Investigator: Christopher Darus         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jill Hayden    734-936-8349    jhayden@med.umich.edu   
Principal Investigator: Anthony Opipari         
Beyer Research Recruiting
Kalamazoo, Michigan, United States, 49009
Contact: Lucy Wright Pelletier    269-372-7800    lwpelletier@beyerresearch.com   
Principal Investigator: Roger Beyer         
United States, Mississippi
St. Dominic Gynecologic Oncology Recruiting
Jackson, Mississippi, United States, 39216
Contact: Regina Outlaw    601-200-4974    routlaw@stdom.com   
Principal Investigator: D. Paul Seago         
United States, Nebraska
Meridian Clinical Research Norfolk Recruiting
Norfolk, Nebraska, United States, 68701
Contact: Alison Pierce    605-232-9000    apierce@mcrmed.com   
Principal Investigator: Keith Vrbicky         
United States, New Jersey
Rutgers New Jersey Recruiting
Newark, New Jersey, United States, 07103
Contact: Randall Teeter    973-972-8367    randall.teeter@njms.rutgers.edu   
Principal Investigator: Mark Einstein         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Melissa Hudson    718-405-8214    MEHUDSON@montefiore.org   
Principal Investigator: Akiva Novetsky         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Reena Vattakalam    212-342-6895    rmv2110@cumc.columbia.edu   
Principal Investigator: Ana Tergas         
United States, North Carolina
Lyndhurst Clinical Research Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Robert Parker    336-354-1076    lauren.jones@unifiedhc.com   
Principal Investigator: Robert Parker         
United States, Ohio
Complete HealthCare for Women, Inc. Recruiting
Columbus, Ohio, United States, 43231
Contact: Sudha Suthanthira    614-682-5182    sutha@drsamuel.org   
Principal Investigator: Samuel Milroy         
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Gina Herbert    405-271-8001 ext 46205    Gina-Herbert@ouhsc.edu   
Principal Investigator: Katherine Smith         
United States, Pennsylvania
University of Pittsburgh Medical Center - Magee Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Carol Kageman    412-641-2588    kagemannca@upmc.edu   
Principal Investigator: Robert Edwards         
United States, Tennessee
Chattanooga's Program in Women's Oncology Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Kim Donelson    423-266-3636    Kimberly.Donelson@erlanger.org   
Principal Investigator: Stephen DePasquale         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-2519
Contact: The Eligibility Office    800-811-8480      
Principal Investigator: Ronald Alvarez         
United States, Wisconsin
Froedtert and The Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Qiana Christian    414-805-4763    qchristian@mcw.edu   
Principal Investigator: William Bradley         
Puerto Rico
Puerto Rico Clinical & Translational Research Consortium University District Hospital, First Floor Medical Center Recruiting
Rio Piedras, Puerto Rico, 00935
Contact: Josefina Romaguera    787-245-8082    josefina.romaguera@upr.edu   
Contact: Janice Diaz    787-759-0306    janice.diaz2@upr.edu   
Principal Investigator: Josefina Romaguera         
Sponsors and Collaborators
Inovio Pharmaceuticals
Investigators
Study Director: ShuPing Yang, MD Inovio Pharmaceuticals

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 10, 2018
Last Verified: September 2018

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:
Carcinoma in Situ
Squamous Intraepithelial Lesions of the Cervix
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
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