REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

Completed · Phase 3 · Has a placebo group

Conditions studied: Cervical Dysplasia, Cervical High Grade Squamous Intraepithelial Lesion, HSIL

In brief

HPV-303 is a prospective, randomized, double-blind, placebo-controlled study of VGX-3100 delivered intramuscularly (IM) followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed high-grade squamous intraepithelial lesions (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) of the cervix, associated with human papillomavirus (HPV-16) and/or HPV-18.

Key facts

Study ID

NCT03721978

Run by

Inovio Pharmaceuticals

People needed

203

Starts

2019-02-28

Expected to finish

2022-09-15

Last updated by the study team

2024-10-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women aged 18 years and above
• Confirmed cervical infection with HPV types 16 and/or 18 at screening
• Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for diagnosis scheduled to be collected within 10 weeks prior to anticipated date of first dose of study drug
• Confirmed histologic evidence of cervical HSIL at screening
• Must be judged by Investigator to be an appropriate candidate for the protocol-specified procedure required at Week 36
• With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with failure rate of less than 1% per year when used consistently and correctly from screening until Week 36
• Normal screening electrocardiogram (ECG)

You may not qualify if…

• Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar, vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologic specimen at screening
• Cervical lesion(s) that cannot be fully visualized on colposcopy
• History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, or insufficient for diagnosis
• Treatment for cervical HSIL within 4 weeks prior to screening
• Pregnant, breastfeeding or considering becoming pregnant during the study
• History of previous therapeutic HPV vaccination
• Immunosuppression as a result of underlying illness or treatment
• Receipt of any non-study, non-live vaccine within 2 weeks of Day 0
• Receipt of any non-study, live vaccine within 4 weeks of Day 0
• Current or history of clinically significant, medically unstable disease or condition which, in the judgment of the investigator, would jeopardize the safety of the participant, interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results
• Presence of acute or chronic bleeding or clotting disorder that would contraindicate IM injections, or use of blood thinners within 2 weeks of Day 0
• Participation in an interventional study with an investigational compound or device within 30 days of signing informed consent
• Less than two acceptable sites available for IM injection

Where it is running

• Nuvance Health — Danbury, Connecticut, United States
• Christiana Care Health System — Newark, Delaware, United States
• Altus Research — Lake Worth, Florida, United States
• Salom and Tangir LLC — Miramar, Florida, United States
• Precision Clinical Research, LLC — Sunrise, Florida, United States
• Augusta University — Augusta, Georgia, United States
• Affinity Clinical Research Institute — Oak Brook, Illinois, United States
• Praetorian Pharmaceutical Research, LLC — Marrero, Louisiana, United States
• Unified Women's Clinical Research - Hagerstown — Hagerstown, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Saginaw Valley Medical Research Group LLC — Saginaw, Michigan, United States
• Meridian Clinical Research Norfolk — Norfolk, Nebraska, United States
• New Jersey Medical School — Newark, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Suffolk Obstetrics and Gynecology — Port Jefferson, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Unified Women's Clinical Research - Greensboro — Greensboro, North Carolina, United States
• Unified Women's Clinical Research - Morehead City — Morehead City, North Carolina, United States
• Lyndhurst Clinical Research — Winston-Salem, North Carolina, United States
• ClinOhio Research Services — Columbus, Ohio, United States
• Obstetrics & Gynecology Associates, Inc. — Fairfield, Ohio, United States
• Frontier Clinical Research-Smithfield — Smithfield, Pennsylvania, United States
• Venus Gynecology, LLC — Myrtle Beach, South Carolina, United States
• Women's Physician Group Suite 203 — Memphis, Tennessee, United States
• Visions Clinical Research- Tucson — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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