REVEAL 1 (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-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) associated with human papillomavirus (HPV) 16 and/or HPV-18.

Key facts

Study ID

NCT03185013

Run by

Inovio Pharmaceuticals

People needed

201

Starts

2017-06-28

Expected to finish

2021-04-06

Last updated by the study team

2023-07-27

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

• Women's Health Research — Scottsdale, Arizona, United States
• Visions Clinical Research-Tucson — Tucson, Arizona, United States
• Women's Medical Research Group — Clearwater, Florida, United States
• Altus Research — Lake Worth, Florida, United States
• Salom and Tangir LLC — Miramar, Florida, United States
• Comprehensive Clinical Trials LLC — West Palm Beach, Florida, United States
• Augusta University — Augusta, Georgia, United States
• Praetorian Pharmaceutical Research, LLC — Marrero, Louisiana, 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
• Lyndhurst Clinical Research — Winston-Salem, North Carolina, United States
• Greenville Pharmaceutical Research, Inc. — Greenville, South Carolina, United States
• Magnolia Ob/Gyn Research Center, LLC — Myrtle Beach, South Carolina, United States
• Chattanooga Medical Research Inc — Chattanooga, Tennessee, United States
• Women's Physician Group — Memphis, Tennessee, United States
• UAG Innovation Women Research, LLC — Houston, Texas, United States
• Group For Women — Norfolk, Virginia, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States
• Instituto de Ginecología — Rosario, Santa Fe Province, Argentina
• Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
• DIM Clínica Privada — Ramos Mejía, Argentina
• Mesa Obstetricians and Gynecologist — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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