drugset / Trial / NCT02262741

A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer

NCT02262741

Phase 1 Completed 71 enrolled MedImmune LLC
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

EvaluationDrugModalityDoseRoute
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