drugset / Trial / NCT04369937
HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma
Phase 2
Completed
18 enrolled
Dan Zandberg
ISA Pharmaceuticals · collabMerck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
This clinical trial will evaluate a new combination of pembrolizumab, HPV-16 E6/E7 specific therapeutic vaccination (ISA101b) and cisplatin-based chemoradiotherapy for patients with newly diagnosed, local-regionally advanced, intermediate risk HPV-associated head and neck squamous cell carcinoma.
Timeline
- Start
- 2020-07-06
- Primary completion
- 2025-03-12
- Completion
- 2026-03-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |
| Subject | PELTOPEPIMUT-S | Vaccine | 100 ug | Subcutaneous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |