NCT02576509已完成3 期
A Randomized, Multi-center Phase III Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (CheckMate 459: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 459)
Bristol-Myers Squibb138 个研究点 分布在 6 个国家目标入组 743 人开始时间: 2015年12月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 743
- 试验地点
- 138
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.
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 advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
- •Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4 weeks prior to the baseline scan
- •Child-Pugh Class A
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- •Prior liver transplant
- •Active, known, or suspected autoimmune disease
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Nivolumab
Experimental
Nivolumab specified dose on specified days
干预措施: Nivolumab (Drug)
Sorafenib
Active Comparator
Sorafenib specified dose on specified days
干预措施: Sorafenib (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: time from the date of randomization to the date of death due to any cause, assessed up to June 2019 (approximately 41 months)
OS is defined as the time from the date of randomization to the date of death due to any cause in all randomized participants. Participants who are alive will be censored at the last known alive dates. Based on Kaplan-Meier Estimates.
次要结局
- Objective Response Rate (ORR) Per BICR RECIST 1.1(the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months))
- Progression-Free Survival (PFS)(time from the date of randomization to the date of the first objectively documented tumor progression or death, assessed up to May 2019 (approximately 40 months))
- Efficacy Based on PD-L1 Expression - OS and PFS(the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months))
- Efficacy Based on PD-L1 Expression - ORR(the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months))
研究者
研究点 (138)
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