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
This is an open-label Phase Ib-II trial to evaluate the safety and efficacy of GX-188E (IM administration using Ichor TDS-IM device) + pembrolizumab (P) in patients with advanced HPV-16+ or HPV-18+ cervical cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Inje University Busan Paik Hospital
Busan, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
National Cancer Center
Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
DLT Evaluation for Safety and Tolerability(Part A)
Patient will be evaluated for the first 21 days for dose-limiting toxicities.
Time frame: within 21days
ORR for Efficacy (Part B&C)
ORR within 24 weeks (ORR24) evaluated by RECIST v1.1
Time frame: within 24 weeks
ORR for Efficacy (Part A)
Overall Response Rate within 24 weeks (ORR24) by RECIST v1.1 and immune-related Response Criteria (irRC)
Time frame: within 24 weeks
BORR (Part B&C)
Best Overall Response Rate(BORR) by RECIST v1.1
Time frame: up to 1 year
Time-to-Best Response
Time-to-Best Response by RECIST v1.1 and iRECIST
Time frame: up to 1 year
Duration of Response (DOR)
Duration of Response (DOR) by RECIST v1.1 and iRECIST
Time frame: up to 1 year
Progression-Free Survival (PFS)
6month- PFS by RECIST v1.1 and iRECIST
Time frame: up to 6 months
Overall Survival (OS)
Overall Survival (OS) by RECIST v1.1 and iRECIST
Time frame: up to 1 year
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Gyeonggi-do, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea