A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma

This is a randomized, double-blind, placebo-controlled, multi-center, global Phase III study
to determine the efficacy and safety of transarterial chemoembolization (TACE) treatment in
combination with durvalumab monotherapy or TACE given with durvalumab plus bevacizumab
therapy compared to TACE therapy alone in patients with locoregional hepatocellular carcinoma
not amenable to curative therapy

Key Inclusion Criteria:

- No evidence of extrahepatic disease on baseline imaging

- Disease not amenable to curative surgery or transplantation or curative ablation but
disease amenable to TACE

- Child-Pugh score class A to B7 and Eastern Cooperative Oncology Group (ECOG)
performance status of 0 or 1 at enrollment

- Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria

- Adequate organ and marrow function

Key Exclusion Criteria

- Any history of nephrotic or nephritic syndrome

- Clinically significant cardiovascular disease or history of arterioembolic event
including a stroke or myocardial infarction

- Any prior or current evidence of coagulopathy or bleeding diathesis or patients who
had any kind of surgery in the past 28 days

- History of abdominal fistula or GI perforation, non healed gastric ulcer that is
refractory to treatment, or active GI bleeding within 6 months prior to enrollment

- Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded