A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma

Bristol-Myers Squibb387 个研究点分布在 8 个国家目标入组 732 人2019年9月30日

适应症Hepatocellular Carcinoma

干预措施Nivolumab Sorafenib Ipilimumab lenvatinib

概览

阶段: 3 期
干预措施: Nivolumab
疾病 / 适应症: Hepatocellular Carcinoma
发起方: Bristol-Myers Squibb
入组人数: 732
试验地点: 387
主要终点: Overall Survival (OS)
状态: 进行中（未招募）
最后更新: 26天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验相关资讯

概览

简要总结

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

注册库

clinicaltrials.gov

开始日期

2019年9月30日

结束日期

2026年7月9日

最后更新

26天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Bristol-Myers Squibb

责任方

Sponsor

入排标准

入选标准

•Participants must have a diagnosis of HCC based on histological confirmation
•Participants must have an advanced HCC
•Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
•Child-Pugh score 5 or 6
•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
•Episodes of hepatic encephalopathy (greater than or equal to \[\>=\] Grade 2) within 12 months prior to randomization
•Active brain metastases or leptomeningeal metastases
•Other protocol-defined inclusion/exclusion criteria apply.