The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer

Sponsor
Genexine, Inc.
Study ID
NCT03444376
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GX-188E — DRUG
    GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
  • KEYTRUDA® — DRUG
    pembrolizumab(100mg/4mL/vial), Intravenous administration

Study Details

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

Key Dates

Start date
Jun 19, 2018
Status verified
Jul 2025
Primary completion
Apr 29, 2022
Completion
Dec 21, 2023

Study Design

Enrollment
65 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GX-188E, KEYTRUDA®
    GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg

Primary Outcome Measure

DLT Evaluation for Safety and Tolerability(Part A) [ Time Frame: within 21days ]

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