This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which participants receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.
This is a multicenter, randomized, open-label, controlled Phase 3 trial of cabozantinib in combination with atezolizumab versus sorafenib in adults with advanced HCC who have not received previous systemic anticancer therapy in the advanced HCC setting. The primary objective of this study is to evaluate the effect of cabozantinib in combination with atezolizumab on the duration of progression-free survival (PFS) and duration of overall survival (OS) versus sorafenib. The secondary objective is to evaluate the activity of single-agent cabozantinib compared with sorafenib in this patient population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
837
Supplied as 20-mg tablets; administered orally daily at 40 mg
Supplied as 60-mg tablets; administered orally once daily at 60 mg
Supplied as 200-mg tablets; administered orally twice daily at 400 mg
Supplied as 1200 mg/20 mL (60 mg/mL) in sing-dose vials; administered as an intravenous (IV) infusion q3w
Exelixis Clinical Site #208
Phoenix, Arizona, United States
Exelixis Clinical Site #159
Tucson, Arizona, United States
Exelixis Clinical Site #44
La Jolla, California, United States
Exelixis Clinical Site #112
Los Angeles, California, United States
Exelixis Clinical Site #200
Orange, California, United States
Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population
PFS was defined as the time from randomization to the earlier of either the date of radiographic progression defined as a 20% increase in the sum of the longest diameters of target lesions, or the unequivocal appearance of new lesions, or progression of non-target disease per Blinded Independent Radiology Committee (BIRC) or the date of death due to any cause per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: From the date of first participant randomization up to 28 months
Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population
OS was defined as the time from randomization to death due to any cause.
Time frame: From the date of first participant randomization up to 36 months
PFS for the Single-Agent Cabozantinib Arm Versus the Control Arm in the ITT Population
PFS was defined as the time from randomization to the earlier of either the date of radiographic progression per BIRC or the date of death due to any cause per RECIST version 1.1.
Time frame: From the date of first participant randomization up to 28 months
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Exelixis Clinical Site #2
Rialto, California, United States
Exelixis Clinical Site #207
San Diego, California, United States
Exelixis Clinical Site #109
San Francisco, California, United States
Exelixis Clinical Site #54
San Francisco, California, United States
Exelixis Clinical Site #58
Washington D.C., District of Columbia, United States
...and 235 more locations