A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma

NCT02519348 ↗

Phase 2 Active not recruiting 433 enrolled MedImmune LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, pharmacodynamics, and immunogenicity of durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or bevacizumab in advanced hepatocellular carcinoma.

Timeline

Start: 2015-10-19
Primary completion: 2020-11-06
Completion: 2026-12-18

Publications

Kelley RK, Sangro B, Harris W, Ikeda M, Okusaka T, Kang YK, Qin S, Tai DW, Lim HY, Yau T, Yong WP, Cheng AL, Gasbarrini A, Damian S, Bruix J, Borad M, Bendell J, Kim TY, Standifer N, He P, Makowsky M, Negro A, Kudo M, Abou-Alfa GK. Safety, Efficacy, and Pharmacodynamics of Tremelimumab Plus Durvalumab for Patients With Unresectable Hepatocellular Carcinoma: Randomized Expansion of a Phase I/II Study. J Clin Oncol. 2021 Sep 20;39(27):2991-3001. doi: 10.1200/JCO.20.03555. Epub 2021 Jul 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Subject	Durvalumab	Monoclonal antibody	20 mg/kg	Intravenous
Subject	Durvalumab	Monoclonal antibody	1120 mg	Intravenous
Subject	Durvalumab	Monoclonal antibody	1500 mg	Intravenous
Subject	Tremelimumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Tremelimumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Tremelimumab	Monoclonal antibody	75 mg	Intravenous
Subject	Tremelimumab	Monoclonal antibody	300 mg	Intravenous
Subject	Tremelimumab	Monoclonal antibody	750 mg	Intravenous

A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma

Summary

Timeline

Publications

Drugs

Indications