A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma
This is a Phase III, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, international study assessing the efficacy and safety of durvalumab + tremelimumab + TACE with or without lenvatinib compared with TACE alone in participants with locoregional HCC not amenable to curative therapy (eg, surgical resection, transplantation, or ablation).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
760
Tremelimumab IV (intravenous)
Durvalumab IV (intravenous)
TACE (chemo and embolic agent injection into the hepatic artery)
Progression Free Survival (PFS) for Arm A vs Arm C
PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause
Time frame: Approximately 5 years
Overall Survival (OS) for Arm A vs Arm C
OS is defined as the time from the date of randomization until death due to any cause
Time frame: Approximately 5 years
Progression Free Survival (PFS) for Arm B vs Arm C
PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause
Time frame: Approximately 5 years
Overall Survival (OS) for Arm B vs Arm C
OS is defined as the time from the date of randomization until death due to any cause
Time frame: Approximately 5 years
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Lenvatinib (oral)
Research Site
Birmingham, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Yuma, Arizona, United States
Research Site
Glendale, California, United States
Research Site
Atlanta, Georgia, United States
Research Site
Baltimore, Maryland, United States
Research Site
Santa Fe, New Mexico, United States
Research Site
Commack, New York, United States
Research Site
New York, New York, United States
Research Site
Memphis, Tennessee, United States
...and 161 more locations