Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod.

Study Overview
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Brief Summary
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This is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3.

Official Title
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A Randomized, Open-label Study to Evaluate the Safety and Efficacy of GX-188E, a DNA Therapeutic Vaccine Administered Intramuscularly by Electroporation, With GX-I7 Intravaginal Application or Imiquimod Topical Application in HPV16 and/or 18 Positive Patients With CIN3.

Conditions
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Cervical Intraepithelial Neoplasia 3

Intervention / Treatment
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* Biological: GX-188E, GX-I7
* Biological: GX-188E, Imiquimod


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to comply with all study procedures and voluntarily signs informed consent form. Female subjects age 19-50 years. HPV 16 and/or 18 positive. Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area Histopathologically diagnosed with Cervical Intraepithelial Neoplasia 3, CIN 3. Exclusion Criteria: Pregnancy or breastfeeding History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines are not excluded). Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV). Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GX-188E, GX-I7<br>GX-188E + GX-I7 | Biological: GX-188E, GX-I7<br>* Experimental: 1mg of GX-188E administered IM using EP device 3 times and 3mg of GX-I7 administered in cervix 4 times.<br>|
| Experimental: GX-188E, Imiquimod<br>GX-188E + Imiquimod | Biological: GX-188E, Imiquimod<br>* 1mg of GX-188E administered IM using EP device 3 times and 12.5mg of Imiquimod application at cervix 8 times.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects. |  | at week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of subjects with clearance of HPV 16 or 18 and histopathological regression of cervical lesions to CIN 1 or less. |  | at week 20, and week 36 | 
| The change of cytology of uterine cervix compared to baseline. |  | at screening, week 12, week 20, and week 36 | 
| Flt-3L concentrations in blood samples. |  | at week 14, week 20, and week 36. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Investigator trial, Cervical Intraepithelial Neoplasia