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

Last updated: October 15, 2024
Sponsor: Inovio Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Cervical Dysplasia

Precancerous Condition

Lung Cancer

Treatment

CELLECTRA™-5PSP

VGX-3100

Matched Placebo

Clinical Study ID

NCT03721978
HPV-303
2018-004114-17
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 Committeefor diagnosis scheduled to be collected within 10 weeks prior to anticipated date offirst dose of study drug

  • Confirmed histologic evidence of cervical HSIL at screening

  • Must be judged by Investigator to be an appropriate candidate for theprotocol-specified procedure required at Week 36

  • With respect to their reproductive capacity must be post-menopausal or surgicallysterile 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)

Exclusion

Exclusion Criteria:

  • Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar,vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologicspecimen at screening

  • Cervical lesion(s) that cannot be fully visualized on colposcopy

  • History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, orinsufficient 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 orcondition which, in the judgment of the investigator, would jeopardize the safety ofthe participant, interfere with study assessments or endpoint evaluation, orotherwise impact the validity of the study results

  • Presence of acute or chronic bleeding or clotting disorder that would contraindicateIM injections, or use of blood thinners within 2 weeks of Day 0

  • Participation in an interventional study with an investigational compound or devicewithin 30 days of signing informed consent

  • Less than two acceptable sites available for IM injection

Study Design

Total Participants: 203
Treatment Group(s): 3
Primary Treatment: CELLECTRA™-5PSP
Phase: 3
Study Start date:
February 28, 2019
Estimated Completion Date:
September 15, 2022

Connect with a study center

  • Instituto de Ginecología

    Rosario, Santa Fe S2000PBB
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de Buenos Aires, C1181ACH
    Argentina

    Site Not Available

  • DIM Clinica Privada

    Ramos Mejía, B1704ETD
    Argentina

    Site Not Available

  • Associação Obras Sociais Irmã Dulce Hospital Santo Antônio

    Salvador, Bahia 40420-000
    Brazil

    Site Not Available

  • Hospital das Clinicas de Goiânia

    Goiânia, Goiás 74605-050
    Brazil

    Site Not Available

  • Hospital Erasto Gaertner

    Curitiba, Paraná 80530-010
    Brazil

    Site Not Available

  • Hospital Amaral Carvalho

    Jaú, São Paulo 17210-120
    Brazil

    Site Not Available

  • Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP

    Ribeirao Preto, São Paulo 14048-900
    Brazil

    Site Not Available

  • Pärnu Hospital

    Pärnu, Pärnumaa EE-80010
    Estonia

    Site Not Available

  • East Tallinn Central Hospital Womens Clinic

    Tallinn, 10119
    Estonia

    Site Not Available

  • Tartu University Hospital

    Tartu, 51014
    Estonia

    Site Not Available

  • HUS Naistentaudit ja synnytykset

    Helsinki, Uusimaa FI-00290
    Finland

    Site Not Available

  • Northern Savo Hospital District Muncipal Federation

    Kuopio, FI-70210
    Finland

    Site Not Available

  • Vilnius District Central Outpatient Clinic

    Vilnius, LT-01117
    Lithuania

    Site Not Available

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT-08661
    Lithuania

    Site Not Available

  • Niepubliczny Zakład Opieki Zdrowotnej Profimed

    Lublin, Lubelskie 20-880
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

    Lublin, Lubelskie 20-880
    Poland

    Site Not Available

  • Centrum Medyczne Angelius Provita

    Śląskie, 40-611
    Poland

    Site Not Available

  • Puerto Rico Translational Research Center (PRTRC)

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • Puerto Rico Translational Research Center (PRTRC)

    San Juan, 00935
    Puerto Rico

    Site Not Available

  • Lynette Reynders Private Practice

    Centurion, Gauteng 0157
    South Africa

    Site Not Available

  • University of Cape Town

    Cape Town, Western Cape 7925
    South Africa

    Site Not Available

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026
    Spain

    Site Not Available

  • Mesa Obstetricians and Gynecologist

    Phoenix, Arizona 85014
    United States

    Site Not Available

  • Visions Clinical Research- Tucson

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Nuvance Health

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Christiana Care Health System

    Newark, Delaware 19713
    United States

    Site Not Available

  • Women's Medical Research Group

    Clearwater, Florida 33759
    United States

    Site Not Available

  • Altus Research

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • Salom and Tangir LLC

    Miramar, Florida 33027
    United States

    Site Not Available

  • Precision Clinical Research, LLC

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Affinity Clinical Research Institute

    Oak Brook, Illinois 60523
    United States

    Site Not Available

  • Praetorian Pharmaceutical Research, LLC

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Unified Women's Clinical Research - Hagerstown

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Saginaw Valley Medical Research Group LLC

    Saginaw, Michigan 48604
    United States

    Site Not Available

  • Meridian Clinical Research Norfolk

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • New Jersey Medical School

    Newark, New Jersey 07103
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10583
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Suffolk Obstetrics and Gynecology

    Port Jefferson, New York 11777
    United States

    Site Not Available

  • Unified Women's Clinical Research - Greensboro

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Unified Women's Clinical Research - Morehead City

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Lyndhurst Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • ClinOhio Research Services

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Obstetrics & Gynecology Associates, Inc.

    Fairfield, Ohio 45014
    United States

    Site Not Available

  • Frontier Clinical Research-Smithfield

    Smithfield, Pennsylvania 15478
    United States

    Site Not Available

  • Venus Gynecology, LLC

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Women's Physician Group Suite 203

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Storks Research

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Group For Women - Tidewater Clinical Research Inc.

    Virginia Beach, Virginia 23456
    United States

    Site Not Available

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