A Phase 2, Randomized, Open-labeled Clinical Study Investigating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab Plus BAT1706 and of Tislelizumab Plus BAT1706 as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 28
- 主要终点
- Objective Response Rate (ORR) as Assessed by the Investigator
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm A: Ociperlimab + Tislelizumab + BAT1706
Participants received tislelizumab 200 milligrams (mg) intravenously once every 3 weeks followed by BAT1706 15 milligrams per kilogram (mg/kg) intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
干预措施: Ociperlimab (Drug)
Arm A: Ociperlimab + Tislelizumab + BAT1706
Participants received tislelizumab 200 milligrams (mg) intravenously once every 3 weeks followed by BAT1706 15 milligrams per kilogram (mg/kg) intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
干预措施: Tislelizumab (Drug)
Arm A: Ociperlimab + Tislelizumab + BAT1706
Participants received tislelizumab 200 milligrams (mg) intravenously once every 3 weeks followed by BAT1706 15 milligrams per kilogram (mg/kg) intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
干预措施: BAT1706 (Drug)
Arm B: Tislelizumab + BAT1706
Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
干预措施: Tislelizumab (Drug)
Arm B: Tislelizumab + BAT1706
Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
干预措施: BAT1706 (Drug)
结局指标
主要结局
Objective Response Rate (ORR) as Assessed by the Investigator
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)
ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors version(v) 1.1 (RECIST v1.1). Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
次要结局
- Duration Of Response (DOR) as Assessed by the Investigator(From the first confirmed objective response until the first documentation of disease progression or death, whichever came first (i.e. up to 27 months))
- Time to Response (TTR) as Assessed by the Investigator(From the randomization date to the first documentation of response (up to 27 months))
- Disease Control Rate (DCR) as Assessed by the Investigator(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months))
- Clinical Benefit Rate (CBR) as Assessed by the Investigator(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months))
- Progression-Free Survival (PFS) as Assessed by the Investigator(From the randomization date to the date of first documentation of disease progression or death, whichever came first (i.e., up to 27 months))
- Overall Survival (OS)(From the randomization date until the date of death from any cause (up to 27 months))
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(From the date of the first dose of study drug up to 30 days after last dose of study drug (i.e., up to 27 months))
- Serum Concentrations of Ociperlimab(Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days))
- Serum Concentrations of Tislelizumab(Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days))
- Serum Concentrations of BAT1706(Predose on Day 1 of Cycles 1, 2, 5, 9 and 17; Post dose on Day 1 of Cycles 1 and 5 and Safety Follow-up Visit (i.e., up to 30 days after last dose [up to 27 months]) (each cycle duration = 21-days))
- Number of Participants With Antidrug Antibodies (ADAs) to Ociperlimab, Tislelizumab, and BAT1706(Up to 27 months)