This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
668
Atezolizumab 1200 mg will be administered by IV infusion on Day 1 of each 21-day cycle.
Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
Recurrence-Free Survival (RFS), as Determined by IRF
RFS is defined as the time from randomization to the first documented occurrence of intrahepatic or extrahepatic HCC as determined by an IRF, or death from any cause (whichever occurs first).
Time frame: Baseline up to approximately 33 months
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Time frame: Baseline up to approximately 91 months
RFS as Determined by the Investigator
RFS is defined as the time from randomization to the first documented occurrence of intrahepatic or extrahepatic HCC as determined by an investigator, or death from any cause (whichever occurs first).
Time frame: Baseline up to approximately 91 months
Time to Recurrence (TTR)
TTR defined as the time from randomization to first documented occurrence of intrahepatic or extrahepatic HCC, as determined by the investigator and by an IRF.
Time frame: Baseline up to approximately 91 months
RFS Rate at 24 and 36 Months, as Assessed by the IRF
Time frame: Randomization up to 24 months and up to 36 months
RFS Rate at 24 and 36 Months, as Assessed by the Investigator
Time frame: Randomization up to 24 months and up to 36 months
OS Rate at 24 and 36 Months
OS rate defined as the proportion of patients who have not experienced death from any cause at 24 and 36 months after randomization.
Time frame: Baseline to 24 and 36 months
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Kaiser Permanente Los Angeles
Los Angeles, California, United States
Mercy Medical Center
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Columbia University Medical Center
New York, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Swedish Cancer Inst.
Seattle, Washington, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Lkh-Univ. Klinikum Graz
Graz, Austria
...and 124 more locations
Time to Extrahepatic Spread (EHS) or Macrovascular Invasion
Time to EHS or macrovascular invasion after randomization, defined as the time from randomization to the first appearance of EHS or macrovascular invasion, as determined by the investigator.
Time frame: Baseline up to approximately 91 months
RFS in Pd-L1-High Subgroup
RFS after randomization as determined by the investigator and by an IRF, among patients in the PD-L1-high subgroup.
Time frame: Baseline up to approximately 91 months
Percentage of Participants With Adverse Events
Time frame: Baseline up to approximately 91 months
Serum Concentration of Atezolizumab
Serum concentration of atezolizumab.
Time frame: Prior to any drug administration on Day 1 of Cycles 1, 2, 3, 4, 8, 12, and 16, and 30 minutes after end of atezolizumab infusion on Day 1 of Cycle 1 (each cycle is 21 days)
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Number of participants with anti-drug antibodies to atezolizumab.
Time frame: Prior to any drug administration up to approximately 33 month