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 dyspasia REVEA

Inovio Pharmaceuticals, Inc.0 sites198 target enrollmentAugust 10, 2017

Overview

No summary available.

Registry

who.int

Start Date

August 10, 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);
•9\. Cervical lesion of adequate size to ensure that a visible lesion remains after screening biopsy;

•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);
•4\. Treatment for cervical HSIL within 4 weeks prior to screening;
•5\.Pregnant, breastfeeding or considering becoming pregnant through Week 36 visit;
•6\. History of previous therapeutic HPV vaccination (licensed prophylactic HPV vaccines are allowed, e.g. Gardasil™, Silgard ™, Cervarix™);
•7\. Presence of any unresolved abnormal clinical screening laboratory values of Grade 1 or greater per Common Toxicity Criteria for Adverse Events (CTCAE) v 4\.03 and deemed clinically significant by the investigator within 45 days prior to Day 0;
•8\. Immunosuppression as a result of underlying illness or treatment including:
•a) History of or positive serologic test for HIV at screening (performed within 30 days prior to Day 0\)