drugset / Trial / NCT02262741
A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.
Timeline
- Start
- 2014-10-15
- Primary completion
- 2017-09-21
- Completion
- 2017-09-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 3 mg/kg | Intravenous |