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

NCT ID: NCT03499795

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2021-05-26

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.

Conditions

Anal Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VGX-3100

Adult participants who were HIV negative with histologically confirmed anal or anal/peri-anal HSIL associated with HPV-16 and/or 18, received four 6 mg doses of VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 40 followed immediately by EP using the CELLECTRA™ 5PSP device.

Group Type: EXPERIMENTAL

VGX-3100

Intervention Type: BIOLOGICAL

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.

CELLECTRA™ 5PSP

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: BIOLOGICAL

CELLECTRA™ 5PSP

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inovio Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Skolnik, MD

Role: STUDY_DIRECTOR

Inovio Pharmaceuticals

Locations

Howard Brown Health (HBH)-Sheridan

Chicago, Illinois, United States

Laser Surgery Care

New York, New York, United States

Clinique de Recherche en Sante

Québec, Quebec, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

HPV-203

Identifier Type: -

Identifier Source: org_study_id