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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 : Active, not recruiting
First Posted : April 17, 2018
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 9, 2018
First Posted Date  ICMJE April 17, 2018
Last Update Posted Date April 21, 2020
Actual Study Start Date  ICMJE May 3, 2018
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2020)
  • 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) ]
  • Number of Adverse Events [ Time Frame: From baseline to the Week 88 visit ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Flow Cytometry Response Magnitudes [ Time Frame: At baseline and Week 15 ]
  • Percentage of Participants with No Histologic Evidence of Anal or Anal/Peri-Anal HSIL or No Evidence of HPV-16/18 at Week 36 [ Time Frame: At Week 36 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
  • 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) ]
  • Number of Adverse Events [ Time Frame: From baseline to the Week 88 visit ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Serum Anti-HPV-16 Antibody (Ab) Concentrations [ Time Frame: At baseline and Weeks 15, 36, 64 and 88 ]
  • Serum Anti-HPV-18 Ab Concentrations [ Time Frame: At baseline and Weeks 15, 36, 64 and 88 ]
  • Interferon-gamma ELISpot Response Magnitudes [ Time Frame: At baseline and Weeks 15, 36, 64, and 88 ]
  • Flow Cytometry Response Magnitudes [ Time Frame: At baseline and Week 15 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anal Neoplasm
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Biological: VGX-3100
  • Device: CELLECTRA™ 5PSP
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 1, 2019)
23
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2018)
24
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03499795
Other Study ID Numbers  ICMJE HPV-203
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Inovio Pharmaceuticals
Study Sponsor  ICMJE Inovio Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Prakash Bhuyan, MD, PhD Inovio Pharmaceuticals
PRS Account Inovio Pharmaceuticals
Verification Date April 2020

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