Trials / Completed
CompletedNCT03444376
The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer
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 Type 16 and/or 18 Positive Cervical Cancer
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Genexine, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-06-19
- Primary completion
- 2022-04-29
- Completion
- 2023-12-21
- First posted
- 2018-02-23
- Last updated
- 2025-07-30
- Results posted
- 2025-07-30
Locations
9 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03444376. Inclusion in this directory is not an endorsement.