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About
This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1 monoclonal antibody BGB-A317 in participants with previously treated hepatocellular unresectable carcinoma.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
Prior therapies targeting PD-1 or PD-L1
Has known brain or leptomeningeal metastasis
Tumor thrombus involving main trunk of portal vein or inferior vena cava
Loco-regional therapy to the liver within 4 weeks before enrollment
Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, or acute lung diseases
Has received:
Active autoimmune diseases or history of autoimmune diseases that may relapse
Participant with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
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Interventional model
Masking
249 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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