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

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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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Safety: Number of Participants with Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment and for the Duration of the Study

Condition

Cervical Dysplasia

Intervention

VGX-3100

Study Arms / Comparison Groups

 VGX-3100 + EP
Description:  IM injections with VGX-3100 followed by electroporation (EP) using the CELLECTRA™-5PSP device on Day 0, Week 4 and Week 12.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

201

Start Date

June 28, 2017

Completion Date

April 2021

Primary Completion Date

July 8, 2020

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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Prakash Bhuyan, MD, PHD, , 

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT03185013

Organization ID

HPV-301

Secondary IDs

2016-002761-63

Responsible Party

Sponsor

Study Sponsor

Inovio Pharmaceuticals


Study Sponsor

Prakash Bhuyan, MD, PHD, Study Director, Inovio Pharmaceuticals


Verification Date

February 2021