drugset / Trial / NCT05376553
Study of Cemiplimab - TP Induction Chemotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Phase 1
Enrolling by invitation
24 enrolled
Krzysztof Misiukiewicz
Regeneron Pharmaceuticals · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this research study is to determine the safety and tolerability of two dosing schedules of cemiplimab given in combination with cisplatin and docetaxel induction chemotherapy (TPI) in patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). Cemiplimab is FDA approved for treatment of basal cell and squamous cell carcinoma of the skin as well as non-small cell lung cancer but not for squamous cell carcinoma of head and neck.
Timeline
- Start
- 2022-07-20
- Primary completion
- 2025-10
- Completion
- 2025-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cemiplimab | Monoclonal antibody | 350 mg | Intravenous |
| Subject | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 75 unknown | Intravenous |