REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

Last updated: July 24, 2023
Sponsor: Inovio Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Cervical Intraepithelial Neoplasia

Cervical Dysplasia

Lung Cancer

Treatment

VGX-3100

Placebo

Electroporation (EP)

Clinical Study ID

NCT03185013
HPV-301
2016-002761-63
  • Ages > 18
  • Female

Study Summary

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.

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 Committee fordiagnosis scheduled to be collected within 10 weeks prior to anticipated date of firstdose 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% peryear 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 or conditionwhich, in the judgment of the investigator, would jeopardize the safety of theparticipant, interfere with study assessments or endpoint evaluation, or otherwiseimpact 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: 201
Treatment Group(s): 3
Primary Treatment: VGX-3100
Phase: 3
Study Start date:
June 28, 2017
Estimated Completion Date:
April 06, 2021

Connect with a study center

  • Centro de Diagnostico Urologico SRL

    Buenos Aires, Ciudad Autónoma De BuenosAires C1120AAT
    Argentina

    Site Not Available

  • 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 Clínica Privada

    Ramos Mejía, B1704ETD
    Argentina

    Site Not Available

  • UZ Antwerpen

    Edegem, Antwerpen 2650
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire Ambroise Paré

    Mons, Hainaut 7000
    Belgium

    Site Not Available

  • Ziekenhuis Oost-Limburg

    Genk, Limburg 3600
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Clinique RSF

    Quebec City, Quebec G1S 2L6
    Canada

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Praha 2, Praha, Hlavní Mesto 128 08
    Czechia

    Site Not Available

  • Nemocnice Jihlava, prispevkova organizace

    Jihlava, 586 33
    Czechia

    Site Not Available

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20
    Czechia

    Site Not Available

  • Pärnu Hospital

    Pärnu, Pärnumaa EE-80010
    Estonia

    Site Not Available

  • East Tallinn Central Hospital Womens Clinic

    Tallin, 10119
    Estonia

    Site Not Available

  • Tartu University Hospital

    Tartu, 51014
    Estonia

    Site Not Available

  • Kätilöopiston sairaala

    Helsinki, 290
    Finland

    Site Not Available

  • HUS Naistentaudit ja synnytykset

    Husu, 290
    Finland

    Site Not Available

  • Lääkäriasema Cantti Oy

    Kuopio, FI-70110
    Finland

    Site Not Available

  • Elisabeth Krankenhaus Essen GmbH

    Essen, 45138
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Fondazione Policlinico Universitario A Gemelli

    Roma, Lazio 00168
    Italy

    Site Not Available

  • Istituto Europeo Di Oncologia

    Milan, 20141
    Italy

    Site Not Available

  • Istituto Nazionale Dei Tumori

    Milano, 20133
    Italy

    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

  • Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca

    Guadalajara, Jalisco 44340
    Mexico

    Site Not Available

  • Centro Integral Medico SJR S.C

    San Juan Del Río, Querétaro 76800
    Mexico

    Site Not Available

  • Liga Peruana De Lucha Contra El Cancer

    Lima, 15084
    Peru

    Site Not Available

  • Unidad de Ensayos Clinicos (UNIDEC) del Policlinico Universidad Nacional Mayor de San Marcos

    Lima, 15083
    Peru

    Site Not Available

  • Davao Doctors Hospital

    Davao City, Davao Del Sur
    Philippines

    Site Not Available

  • Perpetual Succour Hospital

    Cebu, 6000
    Philippines

    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

  • Ginekologiczno-Polozniczy Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu

    Poznań, Wielkopolskie 60-535
    Poland

    Site Not Available

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611
    Poland

    Site Not Available

  • Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro

    Aveiro, 3814-501
    Portugal

    Site Not Available

  • Hospital de Braga

    Braga, 4710-243
    Portugal

    Site Not Available

  • Centro Hospitalar E Universitário de Coimbra EPE

    Coimbra, 3000-075
    Portugal

    Site Not Available

  • Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Puerto Rico Translational Research Center (PRTRC)

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • MCM GYNPED, s.r.o.

    Dubnica Nad Váhom, 018 41
    Slovakia

    Site Not Available

  • Univerzitna nemocnica Martin

    Martin, 036 59
    Slovakia

    Site Not Available

  • Lynette Reynders Private Practice

    Centurion, Gauteng 157
    South Africa

    Site Not Available

  • University of Cape Town

    Cape Town, 7925
    South Africa

    Site Not Available

  • Hospital Universitario de Bellvitge

    Hospitalet de Llobregat, Barcelona 8907
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Regional Universitario de Malaga - Hospital Materno Infantil

    Málaga, 29011
    Spain

    Site Not Available

  • Chulalongkorn University

    Bangkok, 10700
    Thailand

    Site Not Available

  • Siriraj Hospital Mahidol University

    Bangkok, 10700
    Thailand

    Site Not Available

  • Aberdeen Royal Infirmary - PPDS

    Aberdeen, AB25 7ZD
    United Kingdom

    Site Not Available

  • St Marys Hospital

    London, W2 1NY
    United Kingdom

    Site Not Available

  • Coastal Clinical Research Inc

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Mesa Obstetricians and Gynecologist

    Mesa, Arizona 85209
    United States

    Site Not Available

  • Women's Health Research

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • Women's Health Research

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Visions Clinical Research-Tucson

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Mommy and Me Medical Group

    Colton, California 92324
    United States

    Site Not Available

  • Women's Medical Research Group

    Clearwater, Florida 33759
    United States

    Site Not Available

  • Unified Women's Clinical Research Gainesville

    Gainesville, Florida 32605
    United States

    Site Not Available

  • Hope Clinical Research LLC

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Altus Research

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • Salom and Tangir LLC

    Miramar, Florida 33461
    United States

    Site Not Available

  • Comprehensive Clinical Trials LLC

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • WR-Mount Vernon Clinical Research

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Hutchinson Clinic

    Hutchinson, Kansas 67502-1131
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Praetorian Pharmaceutical Research, LLC

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • MedPharmics

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Continental Clinical Research Solutions LLC

    Towson, Maryland 21204
    United States

    Site Not Available

  • Beyer Research

    Kalamazoo, Michigan 49009
    United States

    Site Not Available

  • Saginaw Valley Medical Research Group LLC

    Saginaw, Michigan 48604
    United States

    Site Not Available

  • Montana Medical Research

    Missoula, Montana 59808
    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

  • 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

  • Carolina Women's Research and Wellness Center

    Durham, North Carolina 27713
    United States

    Site Not Available

  • Unified Women's Clinical Research Hickory

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • Unified Women's Clinical Research Raleigh

    Raleigh, North Carolina 27607-7514
    United States

    Site Not Available

  • Lyndhurst Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Greenville Pharmaceutical Research, Inc.

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Magnolia Ob/Gyn Research Center, LLC

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Chattanooga Medical Research Inc

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Women's Physician Group

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • UAG Innovation Women Research, LLC

    Houston, Texas 77074
    United States

    Site Not Available

  • MacArthur Obstetrics and Gynecology

    Irving, Texas 75062
    United States

    Site Not Available

  • Eastern Virginia Medical School

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Group For Women

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Multicare Health System

    Covington, Washington 98042
    United States

    Site Not Available

  • Valley Womens Clinic

    Renton, Washington 98055
    United States

    Site Not Available

  • North Spokane Women's Clinic

    Spokane, Washington 99207
    United States

    Site Not Available

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