The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
83
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Incidence of dose-limiting toxicities (DLTs)
Time frame: Up to 6 weeks
Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Assessed up to 3 years
Progression Free Survival (PFS) by BICR per RECIST v1.1 in all randomized participants that are lymphocyte activation gene 3 (LAG-3) positive
Time frame: Assessed up to 3 years
PFS by BICR per RECIST v1.1 in all randomized participants
Time frame: Assessed up to 3 years
ORR by BICR per RECIST v1.1 in all randomized participants that are LAG-3 positive
Time frame: Assessed up to 3 years
Overall Survival (OS) of all randomized participants
Time frame: Assessed up to 3 years
OS of all randomized participants that are LAG-3 positive
Time frame: Assessed up to 3 years
Number of participants with adverse events (AEs)
Time frame: Up to 135 days after participant's last dose
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Specified dose on specified days
Local Institution - 0042
Los Angeles, California, United States
Local Institution - 0039
Los Angeles, California, United States
Local Institution - 0034
San Francisco, California, United States
Local Institution - 0030
Washington D.C., District of Columbia, United States
Local Institution - 0059
Baltimore, Maryland, United States
Local Institution - 0060
Boston, Massachusetts, United States
Local Institution - 0065
Boston, Massachusetts, United States
Local Institution - 0061
New York, New York, United States
Local Institution - 0062
The Bronx, New York, United States
Local Institution - 0033
Milwaukee, Wisconsin, United States
...and 51 more locations