drugset / Trial / NCT02141347

Ph1 to Assess Safety, Tolerability of Tremelimumab/ Tremelimumab+MEDI4736 in Japanese Solid Malignancies/ Mesothelioma

NCT02141347

Phase 1 Completed 65 enrolled AstraZeneca
Non-randomizedOpen-labelOther

Summary

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when given as a monotherapy of tremelimumab in Second- or Third-line Treatment of Japanese Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma

Timeline

Start
2014-05-22
Primary completion
2017-01-27
Completion
2017-01-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 10 mg/kg Intravenous
Subject Durvalumab Monoclonal antibody 15 mg/kg Intravenous
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Tremelimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Tremelimumab Monoclonal antibody 3 mg/kg Intravenous
Subject Tremelimumab Monoclonal antibody 10 mg/kg Intravenous
Subject Tremelimumab Monoclonal antibody 75 mg Intravenous