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

N/AUnknownNCT03206138

Seoul St. Mary's Hospital50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Intraepithelial Neoplasia 3

Interventions

GX-188E, GX-I7BIOLOGICAL

Experimental: 1mg of GX-188E administered IM using EP device 3 times and 3mg of GX-I7 administered in cervix 4 times.

GX-188E, ImiquimodBIOLOGICAL

1mg of GX-188E administered IM using EP device 3 times and 12.5mg of Imiquimod application at cervix 8 times.

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Seoul St. Mary's hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects.

Time frame: at week 20

Secondary Outcomes

Ratio of subjects with clearance of HPV 16 or 18 and histopathological regression of cervical lesions to CIN 1 or less.

Time frame: at week 20, and week 36

The change of cytology of uterine cervix compared to baseline.

Time frame: at screening, week 12, week 20, and week 36

Flt-3L concentrations in blood samples.

Time frame: at week 14, week 20, and week 36.

Central Contacts

Jong-Sup Park

CONTACT

+82-2-2258-2724 jspark@catholic.ac.kr

Data from ClinicalTrials.gov

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