A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab monotherapy or placebo as adjuvant therapy. This study will be conducted in patients with HCC who are at high risk of recurrence after curative hepatic resection or ablation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
908
Durvalumab IV (intravenous)
Bevacizumab IV (intravenous)
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous) or Dextrose for Durvalumab masking
Recurrence-free survival (RFS) for Arm A vs Arm C
RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
Time frame: Up to 49 months after first patient randomized
Recurrence-free survival (RFS) Arm B vs Arm C
RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
Time frame: Up to 49 months after first patient randomized
Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C
OS is defined as the time from the date of randomization until death due to any cause
Time frame: No timeframe
Recurrence-free survival at 24 months (RFS24) and 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C
Proportion of RFS at 24 months and at 36 months
Time frame: At 24 and at 36 months
Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C
TTR is defined as the time from the date of randomization until the date of disease recurrence
Time frame: Up to 49 months after first patient randomized
Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C
Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)
Time frame: Up to 49 months after first patient randomized
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Research Site
Birmingham, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Costa Mesa, California, United States
Research Site
La Jolla, California, United States
Research Site
Long Beach, California, United States
Research Site
Orange, California, United States
Research Site
Sacramento, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Miami, Florida, United States
...and 207 more locations