A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC
About the study
This was a Phase 2, randomized, multicenter, open-label, 2-arm study to investigate the efficacy and safety of ociperlimab in combination with tislelizumab plus BAT1706, and tislelizumab plus BAT1706, as first-line treatment in participants with advanced Hepatocellular Carcinoma (HCC).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Histologically confirmed HCC
- Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease that was not amenable to or had progressed after loco-regional therapy, and was not amenable to a curative treatment approach
- Tumor tissue required for an evaluable programmed cell death protein-ligand 1 (PD-L1) expression result
- No prior systemic therapy for HCC
- At least 1 measurable lesion as defined per RECIST v1.1
- Adequate organ function during screening and before randomization
EXCLUSION CRITERIA
Exclusion Criteria:
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
- Prior therapy with antibody or drug specifically targeting T-cell costimulation or checkpoint pathway; prior treatment with bevacizumab or its biosimilars
- Prior history of >= Grade 2 hepatic encephalopathy
- Leptomeningeal disease or uncontrolled, untreated brain metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases
- Infection (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days of randomization
- Prior allogeneic stem cell transplantation or organ transplantation
- Significant cardiovascular risk factors
- Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Administered a live vaccine <=28 days before randomization
NOTE: Other protocol Inclusion/Exclusion criteria may apply
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Advanced Hepatocellular Carcinoma
Age (in years)
18+
Phase
PHASE2
Participants Needed
94
Est. Completion Date
Feb 1, 2024
Treatment Type
INTERVENTIONAL
Sponsor
BeiGene
ClinicalTrials.gov NCT Identifier
NCT04948697
Study Number
AdvanTIG-206
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