The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer
NCT03444376 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2025-07-30
Summary
A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and Pembrolizumab in Patients with Advanced, Non-Resectable HPV-Positive Cervical Cancer
Conditions
Interventions
- DRUG
-
GX-188E
GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
- DRUG
-
KEYTRUDA®
pembrolizumab(100mg/4mL/vial), Intravenous administration
Sponsors & Collaborators
- collaborator INDUSTRY
-
Genexine, Inc.
lead INDUSTRY
Principal Investigators
-
Soo-Young Hur, M.D · The Catholic University of Korea
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-19
- Primary Completion
- 2022-04-29
- Completion
- 2023-12-21
Countries
- South Korea
Study Locations
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