Spots Global Cancer Trial Database for REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
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Trial Identification
Brief Title: REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™-5PSP for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix
Study ID: NCT03185013
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Mesa Obstetricians and Gynecologist, Mesa, Arizona, United States
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, Argentina
Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aires, , Argentina
DIM Clínica Privada, Ramos Mejía, , Argentina
Centre Hospitalier Universitaire Ambroise Paré, Mons, Hainaut, Belgium
Ziekenhuis Oost-Limburg, Genk, Limburg, Belgium
Pärnu Hospital, Pärnu, Pärnumaa, Estonia
East Tallinn Central Hospital Womens Clinic, Tallin, , Estonia
Tartu University Hospital, Tartu, , Estonia
Kätilöopiston sairaala, Helsinki, , Finland
Lääkäriasema Cantti Oy, Kuopio, , Finland
Elisabeth Krankenhaus Essen GmbH, Essen, , Germany
Universitätsklinikum Hamburg Eppendorf, Hamburg, , Germany
Fondazione Policlinico Universitario A Gemelli, Roma, Lazio, Italy
Istituto Nazionale Dei Tumori, Milano, , Italy
Istituto Europeo Di Oncologia, Milan, , Italy
Vilnius University Hospital Santaros Klinikos, Vilnius, , Lithuania
Vilnius District Central Outpatient Clinic, Vilnius, , Lithuania
Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca, Guadalajara, Jalisco, Mexico
Unidad de Ensayos Clinicos (UNIDEC) del Policlinico Universidad Nacional Mayor de San Marcos, Lima, , Peru
Liga Peruana De Lucha Contra El Cancer, Lima, , Peru
Perpetual Succour Hospital, Cebu, , Philippines
Niepubliczny Zakład Opieki Zdrowotnej Profimed, Lublin, Lubelskie, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin, Lubelskie, Poland
Centrum Medyczne Angelius Provita, Katowice, , Poland
Centro Hospitalar E Universitário de Coimbra EPE, Coimbra, , Portugal
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria, Lisboa, , Portugal
Puerto Rico Translational Research Center (PRTRC), Rio Piedras, , Puerto Rico
MCM GYNPED, s.r.o., Dubnica Nad Váhom, , Slovakia
Univerzitna nemocnica Martin, Martin, , Slovakia
Lynette Reynders Private Practice, Centurion, Gauteng, South Africa
University of Cape Town, Cape Town, , South Africa
Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Chulalongkorn University, Bangkok, , Thailand
Siriraj Hospital Mahidol University, Bangkok, , Thailand
Aberdeen Royal Infirmary - PPDS, Aberdeen, , United Kingdom
St Marys Hospital, London, , United Kingdom
Contact Details
Name: Jeffrey Skolnik, MD
Affiliation: Inovio Pharmaceuticals
Role: STUDY_DIRECTOR
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