drugset / Trial / NCT02369874
Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus SoC therapy in the target patient population.
Timeline
- Start
- 2015-09-09
- Primary completion
- 2018-09-10
- Completion
- 2020-11-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 10 mg/kg | — |
| Subject | Durvalumab | Monoclonal antibody | 20 mg/kg | — |
| Subject | Tremelimumab | Monoclonal antibody | 1 mg/kg | — |
| Comparator | Cetuximab | Monoclonal antibody | — | — |
| Comparator | Methotrexate | Small molecule | — | — |