Cervical Dysplasia Cervical High Grade Squamous Intraepithelial Lesion HSIL
Conditions
Interventions
IM injections with VGX-
3100 followed by electroporation (EP) using the CELLECTRAâ„¢-
5PSP device on Day 0,
Week 4,
and Week 12.,IM injections with matching placebo followed by electroporation (EP) using the CELLECTRAâ„¢-
and Week 12.
VGX-
3100 + EP,Placebo + EP
Sponsors
Inovio Pharmaceuticals, Inc.
Inovio Pharmaceuticals,
Inc.
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy 88 Weeks Combined histopathologic regression of cervical HSIL and virologic clearance of HPV-16 and/or HPV-18 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Baseline to Week 88 Number of Participants with any AEs and SAEs following Investigational Treatment,Evidence of cervical HSIL on histology at the Week 36 visit Week 36 Percentage of Participants with No Evidence of Cervical HSIL at Week 36,Evidence of HPV-16 and/or HPV-18 in cervical samples by type-specific HPV testing Week 36 Percentage of Participants with No Evidence of HPV-16 and/or HPV-18 in Cervical Samples at Week 36,Evidence of LSIL or HSIL Week 36 Percentage of Participants with No Evidence of LSIL or HSIL on histology at the Week 36 visit.,Evaluation for evidence of LSIL or HSIL and no evidence of HPV-16 and/or 18 Week 36 Percentage of Participants with No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18,Evaluation for progression of cervical HSIL to cervical carcinoma From Baseline to Week 36 Percentage of Participants with No Progression of Cervical HSIL to Cervical Carcinoma ,Evaluation for HPV-16 and/or HPV-18 status in specimens from non-cervical anatomic locations Week 36 Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations,Serum Levels of anti-HPV-16 and anti-HPV-18 antibody concentrations At baseline, Week 15, and Week 36 Change from Baseline in Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations ,Change from Baseline in Interferon-Gamma Response Magnitude At baseline, Week 15, and Week 36 Assessment of cellular immune activity on PBMCs isolated from whole blood samples,Change from Baseline in Flow Cytometry Response Magnitude At baseline and Week 15 Assessment of cellular immune activity will be performed using flow cytometry | — |
Countries
Thailand
Contacts
Public ContactPrakash Bhuyan
Sponsor
Outcome results
None listed