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VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL) in Individuals Seronegative for Human Immunodeficiency Virus (HIV)-1/2

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ClinicalTrials.gov Identifier: NCT03499795
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Brief Summary:
This is a phase 2, open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are human immunodeficiency virus (HIV) negative with histologically confirmed anal or anal/peri-anal high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV)-16 and/or HPV-18. Approximately 24 participants will receive at least 3 doses of VGX-3100.

Condition or disease Intervention/treatment Phase
Anal Neoplasm Biological: VGX-3100 Device: CELLECTRA™ 5PSP Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open Label, Study of VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL), (AIN2, AIN3, PAIN2, PAIN3) in Individuals That Are Seronegative for Human Immunodeficiency Virus (HIV)-1/2
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: VGX-3100
Adult participants, who are HIV negative with histologically confirmed anal or anal/peri-anal HSIL associated with HPV-16 and/or 18, will receive VGX-3100 administered by IM injection followed immediately by EP using the CELLECTRA™ 5PSP device. Participants will receive at least 3 doses of VGX-3100 at Day 0, Week 4 and Week 12. For partial responders at Week 36, a fourth dose may be administered at Week 40. All participants are scheduled to be followed to Week 88.
Biological: VGX-3100
One milliliter (1 mL) VGX-3100 (deoxyribonucleic acid [DNA] plasmids encoding E6 and E7 proteins of HPV types 16 and 18) will be injected IM and delivered by EP using CELLECTRA™ 5PSP on Day 0, Week 4 and Week 12, and potentially Week 40.

Device: CELLECTRA™ 5PSP
IM injection of VGX-3100 is followed by EP with the CELLECTRA™ 5PSP device.




Primary Outcome Measures :
  1. Percentage of Participants with No Histologic Evidence of Anal or Anal/Peri-Anal HSIL and No Evidence of HPV-16/18 at Week 36 [ Time Frame: At Week 36 ]

Secondary Outcome Measures :
  1. Number of Local and Systemic Safety Events During 7 Days Following Each Dose [ Time Frame: Days 0-7 (7 days following Day 0 dose), Days 22-29 (7 days following Week 4 dose) and Days 78-85 (7 days following Week 12 dose) ]
  2. Number of Adverse Events [ Time Frame: From baseline to the Week 88 visit ]
  3. Percentage of Participants with No Evidence of Anal or Anal/Peri-Anal HSIL on Histology at the Week 36 visit [ Time Frame: At Week 36 ]
  4. Percentage of Participants with No Evidence of HPV-16/18 from Intra-Anal and/or Peri-Anal Tissue by Type-Specific HPV Testing at the Week 36 Visit [ Time Frame: At Week 36 ]
  5. Percentage of Participants with No Evidence of HPV-16/18 from Intra-Anal Swab by Specific HPV Testing at the Weeks 36, 64, and 88 Visits [ Time Frame: At Weeks 36, 64 and 88 ]
  6. Percentage of Participants with No Evidence of Anal or Anal/Peri-Anal Low-Grade Squamous Intraepithelial Lesion (LSIL) or HSIL on Histology at the Week 36 Visit [ Time Frame: At Week 36 ]
  7. Percentage of Participants with No Progression of Anal or Anal/Peri-Anal HSIL to Carcinoma from Baseline on Histology at the Week 36 Visit [ Time Frame: From baseline to Week 36 ]
  8. Percentage Reduction from Baseline in the Number of Intra-Anal and/or Peri-Anal Lesion(s) as Determined by the Investigator at the Weeks 36, 64 and 88 Visits [ Time Frame: From baseline to Weeks 36, 64 and 88 ]
  9. Percentage Reduction from Baseline in the Size of Peri-Anal Lesion(s) as Determined by the Investigator at the Weeks 36, 64 and 88 Visits [ Time Frame: From baseline to Weeks 36, 64 and 88 ]
  10. Serum Anti-HPV-16 Antibody (Ab) Concentrations [ Time Frame: At baseline and Weeks 15, 36, 64 and 88 ]
  11. Serum Anti-HPV-18 Ab Concentrations [ Time Frame: At baseline and Weeks 15, 36, 64 and 88 ]
  12. Interferon-gamma ELISpot Response Magnitudes [ Time Frame: At baseline and Weeks 15, 36, 64, and 88 ]
  13. Flow Cytometry Response Magnitudes [ Time Frame: At baseline and Week 15 ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Negative screening test for HIV-1/2 within 30 days of Dose 1;
  • Confirmed anal or anal/peri-anal HPV-16/18 infection at Screening by polymerase chain reaction (PCR) from HSIL specimen;
  • Anal tissue specimen/slides for diagnosis must be collected within 10 weeks of first dose of VGX-3100;
  • At least one anal or anal/peri-anal (AIN2/3 and/or PAIN2/PAIN3) lesion that is histologically-confirmed as HSIL at Screening;
  • Appropriate candidate for histology collection procedures (i.e. excision or biopsy) as judged by the Investigator;
  • Female subjects must be post-menopausal, surgically sterile or agree to avoid pregnancy by continued abstinence or use of a contraceptive method with failure rate of less than 1% per year from Screening to one month after last dose of study medication (Week 12 or Week 40)
  • Men who could father a child must agree to use at least one form of birth control during or continued abstinence from heterosexual intercourse prior to the study, for the duration of study participation and one month after last dose of study medication.
  • Normal Screening electrocardiogram (ECG).

Exclusion Criteria:

  • Untreated micro invasive or invasive cancer;
  • Biopsy-proven Vaginal Intraepithelial Neoplasia (VAIN) and not undergoing medical care and/or treatment for VAIN;
  • Biopsy-proven Vulvar Intraepithelial Neoplasia (VIN) and not undergoing medical care and/or treatment for VIN;
  • Biopsy-proven Cervical Intraepithelial Neoplasia (CIN) 2/3 and not undergoing medical care and/or treatment for CIN;
  • Biopsy-proven Penile Intraepithelial Neoplasia (PIN) and not undergoing medical care and/or treatment for PIN;
  • Anal or anal/peri-anal HSIL that is not accessible for sampling by biopsy instrument;
  • Intra-anal and/or peri-anal lesion(s) that cannot be fully visualized at Screening;
  • Inability to have complete and satisfactory high resolution anoscopic exams (HRAs)
  • Any treatment for anal or anal/peri-anal HSIL (e.g. surgery) within 4 weeks of Screening;
  • Pregnant, breast feeding or considering becoming pregnant within one month following the last dose of study medication;
  • Presence of any abnormal clinical laboratory values greater than Grade 1 per Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03 within 45 days prior to Day 0 or less than Grade 1 but deemed clinically significant by the Investigator;
  • Immunosuppression as a result of underlying illness or treatment;
  • History of previous therapeutic HPV vaccination;
  • Receipt of any non-study related non-live vaccine within 2 weeks of any VGX-3100 dose;
  • Receipt of any non-study related live vaccine (e.g. measles vaccine) within 4 weeks of any VGX-3100 dose;
  • Significant acute or chronic medical illness that could be negatively impacted by the electroporation treated as deemed by the Investigator;
  • Current or history of clinically significant, medically unstable disease which, in the judgment of the investigator, would jeopardize the safety of the subject, interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results;
  • Prior major surgery within 4 weeks of Day 0;
  • Participation in an interventional study with an investigational compound or device within 4 weeks of signing the ICF;
  • Any illness or condition that in the opinion of the Investigator may affect the safety of the subject or the evaluation of any study endpoint.

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): NCT03499795


Contacts
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Contact: Inovio Pharmaceuticals Call Center 267-440-4237 clinical.trials@inovio.com

Locations
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United States, Illinois
Howard Brown Health (HBH)-Sheridan Recruiting
Chicago, Illinois, United States, 60613
Contact: Gary Bucher, MD    773-572-5116    garybuchermd@adcmidwest.com   
Principal Investigator: Gary Bucher, MD         
United States, New York
Laser Surgery Care Recruiting
New York, New York, United States, 10011
Contact: Stephen Goldstone    212-242-6500    goldstone.stephen@gmail.com   
Principal Investigator: Stephen Goldstone, MD         
Canada, Quebec
Clinique de Recherche en Sante Recruiting
Québec, Quebec, Canada, G1S2L6
Contact: Celine Bouchard       celinebouchard2@gmail.com   
Principal Investigator: Celine Bouchard, MD         
Sponsors and Collaborators
Inovio Pharmaceuticals
Investigators
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Study Director: Prakash Bhuyan, MD, PhD Inovio Pharmaceuticals

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Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03499795     History of Changes
Other Study ID Numbers: HPV-203
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Inovio Pharmaceuticals:
High-grade squamous intraepithelial lesions (HSIL)
Human papillomavirus (HPV)
HPV-16
HPV-18
Anal intraepithelial neoplasia 2 (AIN2)
Anal intraepithelial neoplasia 3 (AIN3)
Peri-anal intraepithelial neoplasia 2 (PAIN2)
Peri-anal intraepithelial neoplasia 3 (PAIN3)

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Squamous Intraepithelial Lesions of the Cervix
Anus Neoplasms
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Uterine Cervical Dysplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases