Back to resultsREVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (REVEAL 1)
Primary Purpose
Cervical Dysplasia, Cervical High Grade Squamous Intraepithelial Lesion, HSIL
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
VGX-3100
Placebo
Electroporation (EP)
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dysplasia focused on measuring Cervical intraepithelial neoplasia (CIN), Human papillomavirus (HPV), High grade squamous intraepithelial lesion (HSIL), CIN 2, CIN 3, papillomavirus
Eligibility Criteria
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 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)
Exclusion Criteria:
- 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
Sites / Locations
- Mesa Obstetricians and Gynecologist
- Women's Health Research
- Visions Clinical Research-Tucson
- Women's Medical Research Group
- Altus Research
- Salom and Tangir LLC
- Comprehensive Clinical Trials LLC
- Augusta University
- Praetorian Pharmaceutical Research, LLC
- Saginaw Valley Medical Research Group LLC
- Meridian Clinical Research Norfolk
- New Jersey Medical School
- Columbia University Medical Center
- Suffolk Obstetrics and Gynecology
- Lyndhurst Clinical Research
- Greenville Pharmaceutical Research, Inc.
- Magnolia Ob/Gyn Research Center, LLC
- Chattanooga Medical Research Inc
- Women's Physician Group
- UAG Innovation Women Research, LLC
- Group For Women
- Eastern Virginia Medical School
- Instituto de Ginecología
- Hospital Italiano de Buenos Aires
- DIM Clínica Privada
- Centre Hospitalier Universitaire Ambroise Paré
- Ziekenhuis Oost-Limburg
- Pärnu Hospital
- East Tallinn Central Hospital Womens Clinic
- Tartu University Hospital
- Kätilöopiston sairaala
- Lääkäriasema Cantti Oy
- Elisabeth Krankenhaus Essen GmbH
- Universitätsklinikum Hamburg Eppendorf
- Fondazione Policlinico Universitario A Gemelli
- Istituto Nazionale Dei Tumori
- Istituto Europeo Di Oncologia
- Vilnius University Hospital Santaros Klinikos
- Vilnius District Central Outpatient Clinic
- Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca
- Unidad de Ensayos Clinicos (UNIDEC) del Policlinico Universidad Nacional Mayor de San Marcos
- Liga Peruana De Lucha Contra El Cancer
- Perpetual Succour Hospital
- Niepubliczny Zakład Opieki Zdrowotnej Profimed
- Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
- Centrum Medyczne Angelius Provita
- Centro Hospitalar E Universitário de Coimbra EPE
- Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
- Puerto Rico Translational Research Center (PRTRC)
- MCM GYNPED, s.r.o.
- Univerzitna nemocnica Martin
- Lynette Reynders Private Practice
- University of Cape Town
- Hospital Universitario de Bellvitge
- Hospital Clinico San Carlos
- Hospital Universitario 12 de Octubre
- Chulalongkorn University
- Siriraj Hospital Mahidol University
- Aberdeen Royal Infirmary - PPDS
- St Marys Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
VGX-3100 + EP
Placebo + EP
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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®.
Secondary Outcome Measures
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment for the Duration of the Study
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. An SAE is any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
Percentage of Participants With No Evidence of Cervical HSIL on Histology
Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL at Week 36 and participants in which an 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 LSIL.
Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Cervical Samples by Type Specific HPV Testing
Participants with no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.
Percentage of Participants With No Evidence of LSIL or HSIL on Histology
Participants with no histologic evidence of cervical HSIL, squamous atypia, or LSIL at the Week 36 time frame and participants in which an 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 as no evidence of cervical squamous intraepithelial neoplasia 1 (CIN1), CIN2, or CIN3 on biopsies or excisional treatment.
Percentage of Participants With No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18
Participants with no histologic evidence of cervical HSIL, squamous atypia, and LSIL, no evidence of HPV-16 and/or HPV-18 by type specific HPV testing at the Week 36 time, and participants in which an excision or biopsy sample was not obtained between initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined as no evidence of CIN1, CIN2, or CIN3 on biopsies or excisional treatment.
Percentage of Participants With No Progression of Cervical HSIL to Cervical Carcinoma
Participants with no histologic evidence of cervical Adenocarcinoma in situ or cervical carcinoma at the Week 36 timeframe relative to baseline and participants in which an excision or biopsy sample was not obtained between initial dose up to Week 36 were considered as responders.
Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations
Participants with no evidence of HPV-16 and/or HPV-18 on specimens from noncervical anatomic locations (oropharynx, vagina and intra-anal) at the Week 36 time frame were considered as responder.
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
A standardized binding enzyme-linked immunosorbent assay (ELISA) was performed to measure the anti-HPV-16/18 antibody response induced by VGX-3100.
Change From Baseline in Interferon-Gamma Response Magnitude
Assessment of cellular immune activity occurred via the application of the Interferon-γ enzyme-linked immunosorbent spot (IFN-γ ELISpot). Peripheral blood mononuclear cells (PBMCs) isolated from whole blood sample were used for analysis.
Change From Baseline in Flow Cytometry Response Magnitude
Assessment of cellular immune activity was measured using the application flow cytometry for the purposes of performing a Lytic Granule Loading Assay. The Lytic Granule Loading assay examines the following external cellular markers: CD3, CD4, CD8 (T cell identification), CD137, CD38 and CD69 (T cell activation markers) as well as PD-1 (exhaustion/activation marker). Here change from baseline in CD8+CD137+Perforin+, CD8+CD38+Perforin+ and CD8+CD69+Perforin+ are reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03185013
Brief Title
REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
Acronym
REVEAL 1
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 Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
July 8, 2020 (Actual)
Study Completion Date
April 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inovio Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VGX-3100 + EP
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo + EP
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
VGX-3100
Intervention Description
1 mL VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
Intervention Type
Device
Intervention Name(s)
Electroporation (EP)
Intervention Description
Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device.
Primary Outcome Measure Information:
Title
Percentage of Participants With No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples
Description
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®.
Time Frame
Week 36
Secondary Outcome Measure Information:
Title
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment for the Duration of the Study
Description
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. An SAE is any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
Time Frame
From baseline up to Week 88
Title
Percentage of Participants With No Evidence of Cervical HSIL on Histology
Description
Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL at Week 36 and participants in which an 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 LSIL.
Time Frame
Week 36
Title
Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Cervical Samples by Type Specific HPV Testing
Description
Participants with no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.
Time Frame
Week 36
Title
Percentage of Participants With No Evidence of LSIL or HSIL on Histology
Description
Participants with no histologic evidence of cervical HSIL, squamous atypia, or LSIL at the Week 36 time frame and participants in which an 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 as no evidence of cervical squamous intraepithelial neoplasia 1 (CIN1), CIN2, or CIN3 on biopsies or excisional treatment.
Time Frame
Week 36
Title
Percentage of Participants With No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18
Description
Participants with no histologic evidence of cervical HSIL, squamous atypia, and LSIL, no evidence of HPV-16 and/or HPV-18 by type specific HPV testing at the Week 36 time, and participants in which an excision or biopsy sample was not obtained between initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined as no evidence of CIN1, CIN2, or CIN3 on biopsies or excisional treatment.
Time Frame
Week 36
Title
Percentage of Participants With No Progression of Cervical HSIL to Cervical Carcinoma
Description
Participants with no histologic evidence of cervical Adenocarcinoma in situ or cervical carcinoma at the Week 36 timeframe relative to baseline and participants in which an excision or biopsy sample was not obtained between initial dose up to Week 36 were considered as responders.
Time Frame
Week 36
Title
Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations
Description
Participants with no evidence of HPV-16 and/or HPV-18 on specimens from noncervical anatomic locations (oropharynx, vagina and intra-anal) at the Week 36 time frame were considered as responder.
Time Frame
Week 36
Title
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
Description
A standardized binding enzyme-linked immunosorbent assay (ELISA) was performed to measure the anti-HPV-16/18 antibody response induced by VGX-3100.
Time Frame
Week 15 and Week 36
Title
Change From Baseline in Interferon-Gamma Response Magnitude
Description
Assessment of cellular immune activity occurred via the application of the Interferon-γ enzyme-linked immunosorbent spot (IFN-γ ELISpot). Peripheral blood mononuclear cells (PBMCs) isolated from whole blood sample were used for analysis.
Time Frame
Baseline; Week 15 and Week 36
Title
Change From Baseline in Flow Cytometry Response Magnitude
Description
Assessment of cellular immune activity was measured using the application flow cytometry for the purposes of performing a Lytic Granule Loading Assay. The Lytic Granule Loading assay examines the following external cellular markers: CD3, CD4, CD8 (T cell identification), CD137, CD38 and CD69 (T cell activation markers) as well as PD-1 (exhaustion/activation marker). Here change from baseline in CD8+CD137+Perforin+, CD8+CD38+Perforin+ and CD8+CD69+Perforin+ are reported.
Time Frame
Baseline, Week 15
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Skolnik, MD
Organizational Affiliation
Inovio Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Mesa Obstetricians and Gynecologist
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85209
Country
United States
Facility Name
Women's Health Research
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Visions Clinical Research-Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Women's Medical Research Group
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Salom and Tangir LLC
City
Miramar
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Comprehensive Clinical Trials LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Praetorian Pharmaceutical Research, LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Saginaw Valley Medical Research Group LLC
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Meridian Clinical Research Norfolk
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Suffolk Obstetrics and Gynecology
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11777
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Greenville Pharmaceutical Research, Inc.
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Magnolia Ob/Gyn Research Center, LLC
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Chattanooga Medical Research Inc
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Women's Physician Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
UAG Innovation Women Research, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Group For Women
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Instituto de Ginecología
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000PBB
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
DIM Clínica Privada
City
Ramos Mejía
ZIP/Postal Code
B1704ETD
Country
Argentina
Facility Name
Centre Hospitalier Universitaire Ambroise Paré
City
Mons
State/Province
Hainaut
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Pärnu Hospital
City
Pärnu
State/Province
Pärnumaa
ZIP/Postal Code
EE-80010
Country
Estonia
Facility Name
East Tallinn Central Hospital Womens Clinic
City
Tallin
ZIP/Postal Code
10119
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Kätilöopiston sairaala
City
Helsinki
ZIP/Postal Code
290
Country
Finland
Facility Name
Lääkäriasema Cantti Oy
City
Kuopio
ZIP/Postal Code
FI-70110
Country
Finland
Facility Name
Elisabeth Krankenhaus Essen GmbH
City
Essen
ZIP/Postal Code
45138
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Fondazione Policlinico Universitario A Gemelli
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Istituto Nazionale Dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Europeo Di Oncologia
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
LT- 08661
Country
Lithuania
Facility Name
Vilnius District Central Outpatient Clinic
City
Vilnius
ZIP/Postal Code
LT-01117
Country
Lithuania
Facility Name
Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Unidad de Ensayos Clinicos (UNIDEC) del Policlinico Universidad Nacional Mayor de San Marcos
City
Lima
ZIP/Postal Code
15083
Country
Peru
Facility Name
Liga Peruana De Lucha Contra El Cancer
City
Lima
ZIP/Postal Code
15084
Country
Peru
Facility Name
Perpetual Succour Hospital
City
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Niepubliczny Zakład Opieki Zdrowotnej Profimed
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-880
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-880
Country
Poland
Facility Name
Centrum Medyczne Angelius Provita
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Centro Hospitalar E Universitário de Coimbra EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Puerto Rico Translational Research Center (PRTRC)
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
MCM GYNPED, s.r.o.
City
Dubnica Nad Váhom
ZIP/Postal Code
018 41
Country
Slovakia
Facility Name
Univerzitna nemocnica Martin
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Lynette Reynders Private Practice
City
Centurion
State/Province
Gauteng
ZIP/Postal Code
157
Country
South Africa
Facility Name
University of Cape Town
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Hospital Universitario de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Siriraj Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Aberdeen Royal Infirmary - PPDS
City
Aberdeen
ZIP/Postal Code
AB25 7ZD
Country
United Kingdom
Facility Name
St Marys Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
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