drugset / Trial / NCT05286060
Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer
Phase 2
Active not recruiting
56 enrolled
Yonsei University
Genexine, Inc. · collabNeoImmuneTech · collab
RandomizedSingle-groupOpen-labelTreatment
Summary
The study is open label, phase II clinical trial for the Combination of GX-188E HPV DNA Vaccine with GX-I7 or Pembrolizumab OR the Triple Combination of GX-188E HPV DNA Vaccine, GX-I7, and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 or 18 Positive Head and Neck Cancer.
Timeline
- Start
- 2022-03-01
- Primary completion
- 2026-10
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NT-I7 | Protein / enzyme biologic | 360 ug/kg | Intramuscular |
| Subject | NT-I7 | Protein / enzyme biologic | 1200 ug/kg | Intramuscular |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | GX-188E | Vaccine | 2 mg | Intramuscular |