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History of Changes for Study: NCT03721978
REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
Latest version (submitted September 28, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 25, 2018 None (earliest Version on record)
2 October 26, 2018 Study Status
3 January 28, 2019 Study Status
4 March 5, 2019 Study Status
5 April 9, 2019 Recruitment Status, Study Status and Contacts/Locations
6 June 7, 2019 Study Status
7 July 2, 2019 Contacts/Locations, Study Status and Study Identification
8 July 22, 2019 References, Contacts/Locations and Study Status
9 August 19, 2019 Contacts/Locations and Study Status
10 August 23, 2019 Contacts/Locations and Study Status
11 October 2, 2019 Contacts/Locations and Study Status
12 October 31, 2019 Contacts/Locations and Study Status
13 December 3, 2019 Study Status and Contacts/Locations
14 December 20, 2019 Contacts/Locations and Study Status
15 January 31, 2020 Study Status
16 February 5, 2020 Study Status
17 February 28, 2020 Contacts/Locations and Study Status
18 March 31, 2020 Study Status
19 April 20, 2020 Study Status
20 July 1, 2020 Contacts/Locations and Study Status
21 August 4, 2020 Contacts/Locations and Study Status
22 September 1, 2020 Study Status
23 October 5, 2020 Contacts/Locations and Study Status
24 November 3, 2020 Study Status and Contacts/Locations
25 December 2, 2020 Study Status
26 January 14, 2021 Contacts/Locations and Study Status
27 February 2, 2021 Study Status and Contacts/Locations
28 March 5, 2021 Contacts/Locations and Study Status
29 April 5, 2021 Study Status and Contacts/Locations
30 May 28, 2021 Study Status and Contacts/Locations
31 July 1, 2021 Study Status
32 September 29, 2021 Contacts/Locations and Study Status
33 November 18, 2021 Study Status and Contacts/Locations
34 January 7, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
35 March 2, 2022 Study Status, References and Eligibility
36 April 7, 2022 Study Status
37 July 14, 2022 Study Status and Outcome Measures
38 September 28, 2022 Recruitment Status and Study Status
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Study NCT03721978
Submitted Date:  October 25, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: HPV-303
Brief Title: REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
Official Title: Reveal 2: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2018
Overall Status: Not yet recruiting
Study Start: February 28, 2019
Primary Completion: March 1, 2021 [Anticipated]
Study Completion: March 1, 2021 [Anticipated]
First Submitted: October 25, 2018
First Submitted that
Met QC Criteria:
October 25, 2018
First Posted: October 26, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
October 25, 2018
Last Update Posted: October 26, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Inovio Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: HPV-303 is a prospective, randomized, double-blind, placebo-controlled phase 3 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 HPV-16 and/or HPV-18.
Detailed Description:
Open or close this module Conditions
Conditions: Cervical Dysplasia
Cervical High Grade Squamous Intraepithelial Lesion
HSIL
Keywords: Cervical intraepithelial neoplasia (CIN)
CIN 2
CIN 3
Human papillomavirus (HPV)
HPV-16
HPV-18
High Grade Squamous Intraepithelial Lesion (HSIL)
papillomavirus
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 198 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: VGX-3100 + EP
IM injections with VGX-3100 followed by electroporation (EP) using the CELLECTRA™-5PSP device on Day 0, Week 4 and Week 12.
Biological: VGX-3100
1 milliLiter (mL) VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
Device: CELLECTRA™-5PSP
CELLECTRA™-5PSP is used for EP following IM injection of VGX 3100 or placebo on Day 0, Week 4 and Week 12.
Placebo Comparator: Placebo + EP
IM injections with matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4 and Week 12.
Biological: Placebo
1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
Device: CELLECTRA™-5PSP
CELLECTRA™-5PSP is used for EP following IM injection of VGX 3100 or placebo on Day 0, Week 4 and Week 12.
Open or close this module Outcome Measures
Primary Outcome Measures:
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 at Week 36
[ Time Frame: At Week 36 ]

Participants will be evaluated for evidence of cervical HSIL on histology as well as evidence of HPV-16 and/or HPV-18 in cervical samples by type-specific HPV testing at the Week 36 visit.
Secondary Outcome Measures:
1. Safety: Number of Participants with Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment and for the Duration of the Study
[ Time Frame: From baseline to Week 40 ]

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event 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 adverse events. 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.
2. Percentage of Participants with No Evidence of Cervical HSIL at Week 36
[ Time Frame: At Week 36 ]

Participants will be evaluated for evidence of cervical HSIL on histology at the Week 36 visit.
3. Percentage of Participants with No Evidence of HPV-16 and/or HPV-18 in Cervical Samples at Week 36
[ Time Frame: At Week 36 ]

Participants will be evaluated for evidence of HPV-16 and/or HPV-18 in cervical samples by type-specific HPV testing at the Week 36 visit.
4. Percentage of Participants with No Evidence of Low Grade Squamous Intraepithelial Lesion (LSIL) or HSIL at Week 36
[ Time Frame: At Week 36 ]

Participants will be evaluated for evidence of cervical LSIL and HSIL (i.e. no evidence of cervical intraepithelial neoplasia grade 1 [CIN1], CIN2 or CIN3) on histology at the Week 36 visit.
5. Percentage of Participants with No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18 at Week 36
[ Time Frame: At Week 36 ]

Participants will be evaluated for evidence of cervical LSIL and HSIL (i.e. no evidence of CIN1, CIN2 or CIN3) on histology and be evaluated for evidence of HPV-16 and/or HPV-18 in cervical samples by type-specific HPV testing at the Week 36 visit.
6. Percentage of Participants with No Progression of Cervical HSIL to Cervical Carcinoma from Baseline at Week 36
[ Time Frame: At Week 36 ]

Participants will be evaluated for progression of cervical HSIL to cervical carcinoma from baseline on histology at the Week 36 visit.
7. Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations at Week 36
[ Time Frame: At Week 36 ]

Participants will be evaluated for HPV-16 and/or HPV-18 status in specimens from non-cervical anatomic locations (oropharynx, vagina and intra-anal) at the Week 36 Visit.
8. Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Weeks 15 and 36
[ Time Frame: At Weeks 15 and 36 ]

9. Interferon-gamma Response Magnitudes at Baseline, Weeks 15 and 36
[ Time Frame: At Baseline, Weeks 15 and 36 ]

Interferon-gamma response magnitudes will be determined using the ELISpot assay at baseline, Weeks 15 and 36 visits.
10. Cellular Immune Response Magnitudes at Baseline and Week 15
[ Time Frame: At Baseline and Week 15 ]

Using flow cytometry cellular immune response magnitudes will be determined at the baseline and Week 15 visits.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Inovio Call Center
Telephone: 267-440-4237
Email: clinical.trials@inovio.com
Study Officials: Prakash Bhuyan, MD, PhD
Study Director
Inovio Pharmaceuticals
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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