IMbrave 050: A Phase III Trial of Atezolizumab Plus Bevacizumab in High-Risk Hepatocellular Carcinoma after Curative Resection or Ablation
Stephen P. Hack, Jessica Spahn, Minshan Chen, Ann‐Lii Cheng, Ahmed O. Kaseb, Masatoshi Kudo, Han Chu Lee, Adam C. Yopp, Pierce K. H. Chow, Shukui Qin
Abstract
Hepatocellular carcinoma recurs in 70–80% of cases following potentially curative resection or ablation and the immune component of the liver microenvironment plays a key role in recurrence. Many immunosuppressive mechanisms implicated in HCC recurrence are modulated by VEGF and/or immune checkpoints such as PD-L1. Atezolizumab (PD-L1 inhibitor) plus bevacizumab (VEGF inhibitor) has been shown to significantly improve overall survival, progression-free survival and overall response rate in unresectable HCC. Dual PD-L1/VEGF blockade may be effective in reducing HCC recurrence by creating a more immune-favorable microenvironment. We describe the rationale and design of IMbrave 050 (NCT04102098), a randomized, open-label, Phase III study comparing atezolizumab plus bevacizumab versus active surveillance in HCC patients at high-risk of recurrence following curative resection or ablation. The primary end point is recurrence-free survival. Clinical Trial Registration: NCT04102098