jRCT2031200442进行中（未招募）不适用
A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors
Bristol-Myers Squibb0 个研究点目标入组 24 人开始时间: 2021年2月4日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Must have a diagnosis of hepatocellular carcinoma(HCC)based on histological confirmation
- •Must have advanced/metastatic HCC
- •Have to be immunotherapy treatment-naive; no prior immunotherapies are permitted
- •Must have at least one Response Evaluation Criteria in Solid Tumors(RECIST)v1.1 measurable untreated lesion
- •Child-Pugh score of 5 or 6
- •Eastern Cooperative Oncology Group(ECOG)performance status 0 or 1 for ECOG performance status scale
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma
- •Prior organ allograft or allogeneic bone marrow transplantation
- •No uncontrolled or significant cardiovascular disease
- •No active known autoimmune disease
结局指标
主要结局
-
- ORR assessed by BICR using RECIST v1.1
次要结局
- Incidence of AEs, SAEs, AEs leading to discontinuation, death and clinically significant changes in clinical laboratory results
- DCR, DOR, and PFS assessed by BICR and Investigator
- ORR asessed by Investigator
- OS
- Actual dose
- BOR assessed by BICR
- LAG-3 expression
研究者
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