TCTR20170301001
Active, not recruiting
Phase 3
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 HSIL of the cervix.
Inovio Pharmaceuticals, Inc.0 sites201 target enrollmentMarch 1, 2017
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Cervical DysplasiaCervical High Grade Squamous Intraepithelial LesionHSI
- Sponsor
- Inovio Pharmaceuticals, Inc.
- Enrollment
- 201
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •â€¢Women aged 18 years and above
- •â€¢Confirmed cervical infection with HPV types 16 and/or 18 at screening
- •â€¢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
- •â€¢Confirmed histologic evidence of cervical HSIL at screening
- •â€¢Must be judged by Investigator to be an appropriate candidate for the protocol\-specified procedure required at Week 36
- •â€¢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
- •â€¢Normal screening electrocardiogram (ECG)
Exclusion Criteria
- •â€¢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
- •â€¢Cervical lesion(s) that cannot be fully visualized on colposcopy
- •â€¢History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, or insufficient for diagnosis
- •â€¢Treatment for cervical HSIL within 4 weeks prior to screening
- •â€¢Pregnant, breastfeeding or considering becoming pregnant during the study
- •â€¢History of previous therapeutic HPV vaccination
- •â€¢Immunosuppression as a result of underlying illness or treatment
- •â€¢Receipt of any non\-study, non\-live vaccine within 2 weeks of Day 0
- •â€¢Receipt of any non\-study, live vaccine within 4 weeks of Day 0
- •â€¢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
Outcomes
Primary Outcomes
Not specified
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