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

NCT03185013 | Completed Phase 3 Results DMC FDA Drug FDA Device

• 2 other identifiers: HPV-3012016-002761-63
• Study Type: interventional
• Target: 201
• Locations: 18 countries
• Sites: 57

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.

Conditions

Cervical Dysplasia; Cervical High Grade Squamous Intraepithelial Lesion; HSIL

Keywords

Cervical intraepithelial neoplasia (CIN); Human papillomavirus (HPV); High grade squamous intraepithelial lesion (HSIL); CIN 2; CIN 3; papillomavirus

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples

  Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame, and participants in which excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or low-grade intraepithelial lesion (LSIL). Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.

  Week 36

Secondary Outcomes (10)

• Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment for the Duration of the Study

  From baseline up to Week 88

• Percentage of Participants With No Evidence of Cervical HSIL on Histology

  Week 36

• Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Cervical Samples by Type Specific HPV Testing

  Week 36

• Percentage of Participants With No Evidence of LSIL or HSIL on Histology

  Week 36

• Percentage of Participants With No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18

  Week 36

Study Arms (2)

VGX-3100 + EP

EXPERIMENTAL

Participants received three IM injections of 6 milligram (mg) (in 1 milliliter \[mL\]) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

Biological: VGX-3100; Device: Electroporation (EP)

Placebo + EP

PLACEBO COMPARATOR

Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.

Biological: Placebo; Device: Electroporation (EP)

Interventions

VGX-3100 BIOLOGICAL

1 mL VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.

VGX-3100 + EP

Placebo BIOLOGICAL

1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.

Placebo + EP

Electroporation (EP) DEVICE

Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device.

Placebo + EP; VGX-3100 + EP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Inovio Pharmaceuticals: lead

Study Sites (60)

Mesa Obstetricians and Gynecologist

Mesa, Arizona, 85209, United States

Location

Women's Health Research

Scottsdale, Arizona, 85251, United States

Location

Visions Clinical Research-Tucson

Tucson, Arizona, 85712, United States

Location

Women's Medical Research Group

Clearwater, Florida, 33759, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Salom and Tangir LLC

Miramar, Florida, 33461, United States

Location

Comprehensive Clinical Trials LLC

West Palm Beach, Florida, 33409, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Praetorian Pharmaceutical Research, LLC

Marrero, Louisiana, 70072, United States

Location

Saginaw Valley Medical Research Group LLC

Saginaw, Michigan, 48604, United States

Location

Meridian Clinical Research Norfolk

Norfolk, Nebraska, 68701, United States

Location

New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Suffolk Obstetrics and Gynecology

Port Jefferson, New York, 11777, United States

Location

Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Greenville Pharmaceutical Research, Inc.

Greenville, South Carolina, 29615, United States

Location

Magnolia Ob/Gyn Research Center, LLC

Myrtle Beach, South Carolina, 29572, United States

Location

Chattanooga Medical Research Inc

Chattanooga, Tennessee, 37404, United States

Location

Women's Physician Group

Memphis, Tennessee, 38104, United States

Location

UAG Innovation Women Research, LLC

Houston, Texas, 77074, United States

Location

Group For Women

Norfolk, Virginia, 23502, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Instituto de Ginecología

Rosario, Santa Fe Province, S2000PBB, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

DIM Clínica Privada

Ramos Mejía, B1704ETD, Argentina

Location

Centre Hospitalier Universitaire Ambroise Paré

Mons, Hainaut, 7000, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Pärnu Hospital

Pärnu, Pärnumaa, EE-80010, Estonia

Location

East Tallinn Central Hospital Womens Clinic

Tallinn, 10119, Estonia

Location

Tartu University Hospital

Tartu, 51014, Estonia

Location

Kätilöopiston sairaala

Helsinki, 290, Finland

Location

Lääkäriasema Cantti Oy

Kuopio, FI-70110, Finland

Location

Elisabeth Krankenhaus Essen GmbH

Essen, 45138, Germany

Location

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Fondazione Policlinico Universitario A Gemelli

Rome, Lazio, 00168, Italy

Location

Istituto Europeo Di Oncologia

Milan, 20141, Italy

Location

Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, LT- 08661, Lithuania

Location

Vilnius District Central Outpatient Clinic

Vilnius, LT-01117, Lithuania

Location

Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca

Guadalajara, Jalisco, 44340, Mexico

Location

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

Lima, 15083, Peru

Location

Liga Peruana De Lucha Contra El Cancer

Lima, 15084, Peru

Location

Perpetual Succour Hospital

Cebu, 6000, Philippines

Location

Niepubliczny Zakład Opieki Zdrowotnej Profimed

Lublin, Lublin Voivodeship, 20-880, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

Lublin, Lublin Voivodeship, 20-880, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

Location

Centro Hospitalar E Universitário de Coimbra EPE

Coimbra, 3000-075, Portugal

Location

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

Lisbon, 1649-035, Portugal

Location

Puerto Rico Translational Research Center (PRTRC)

Rio Piedras, 00935, Puerto Rico

Location

MCM GYNPED, s.r.o.

Dubnica nad Váhom, 018 41, Slovakia

Location

Univerzitna nemocnica Martin

Martin, 036 59, Slovakia

Location

Lynette Reynders Private Practice

Centurion, Gauteng, 157, South Africa

Location

University of Cape Town

Cape Town, 7925, South Africa

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 8907, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Chulalongkorn University

Bangkok, 10700, Thailand

Location

Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

Location

Aberdeen Royal Infirmary - PPDS

Aberdeen, AB25 7ZD, United Kingdom

Location

St Marys Hospital

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Squamous Intraepithelial Lesions

Interventions

VGX-3100; Electroporation

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Results Point of Contact

• Title: Study Director
• Organization: Inovio Pharmaceuticals

clinical.trials@inovio.com

267-440-4237

Study Officials

• Jeffrey Skolnik, MD

  Inovio Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 14, 2017
• Study Start: June 28, 2017
• Primary Completion: July 8, 2020
• Study Completion: April 6, 2021
• Last Updated: July 27, 2023
• Results First Posted: July 25, 2023

Record last verified: 2023-07

Locations

ES (3); BE (2); IT (3); ZA (2); PT (2); FI (2); PR (1); TH (2); AR (3); PL (3); ME (1); DE (2); PE (2); SL (2); GB (2); PH (1); LI (2); US (22)