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 Kaseb, Masatoshi Kudo, Han Chu Lee, Adam Yopp, Pierce Chow, Shukui Qin, Stephen P Hack, Jessica Spahn, Minshan Chen, Ann-Lii Cheng, Ahmed Kaseb, Masatoshi Kudo, Han Chu Lee, Adam Yopp, Pierce 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.

Keywords: PD-L1; VEGF; ablation; adjuvant treatment; atezolizumab; bevacizumab; hepatocellular carcinoma; recurrence-free survival; resection.

Source: PubMed

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