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 - Randomized Evaluation of VGX-3100 and Electroporation for the treatment of Cervical dysplasia REVEA

Inovio Pharmaceuticals, Inc.0 sites198 target enrollmentAugust 3, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HPV-16 AND/OR HPV-18 RELATED HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESIONS (HSIL) OF THE CERVIX
Sponsor: Inovio Pharmaceuticals, Inc.
Enrollment: 198
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

August 3, 2017

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•Each subject must meet all of the following criteria to be enrolled in the study:
•1\. Women aged 18 years and above and meets the minimum age of
•consent per local regulations;
•2\. Confirmed cervical infection with HPV types 16 and/or 18 at screening by cobasTM HPV test;
•3\. Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for diagnosis must be collected within 10 weeks prior to anticipated date of first dose of study drug;
•4\. Histologic evidence of cervical HSIL as confirmed by PAC at screening;
•5\. Must understand, agree and be able to comply with the requirements of the protocol. Subjects must be willing and able to provide voluntary consent to participate and sign a Consent Form prior to study\-related activities;
•6\. Must be judged by Investigator to be an appropriate candidate for the protocol\-specified procedure (i.e. excision, 4\-quadrant biopsy with ECC, or 4\-quadrant biopsy) required at Week 36;
•7\. Satisfactory colposcopy at screening, defined as full visualization of the squamo\-columnar junction (Type I or II transformation zone) and complete visualization of the upper limit of aceto\-white epithelium or suspected CIN disease;
•8\. Cervical lesion that is accessible for sampling by biopsy instrument (e.g. Mini\-Tischler device);

•Subjects meeting any of the following criteria will be excluded from
•enrollment in the study:
•1\. Microscopic or gross evidence of adenocarcinoma\-in\-situ (AIS), high
•grade vulvar, vaginal (inclusive of cervical HPV\-related lesions that
•extend into the vaginal vault), or anal intraepithelial neoplasia or
•invasive cancer in any histopathologic specimen at screening;
•2\. Cervical lesion(s) that cannot be fully visualized on colposcopy due to
•extension high into cervical canal at screening;
•3\. ECC that shows a potentially untreated carcinoma, untreated HSIL,
•indeterminate, or insufficient for diagnosis (ECC is not required to be performed as part of study screening);