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 (RELATIVITY-073)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 266
- 试验地点
- 127
- 主要终点
- Objective Response Rate(ORR) Assessed by BICR
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.
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
- •Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation
- •Must have advanced/metastatic HCC
- •Have to be immunotherapy treatment-naive in the advanced/metastatic setting
- •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
- •Have received one or two lines of tyrosine kinase inhibitor therapies
- •Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm A : Nivolumab
干预措施: Nivolumab (Biological)
Arm B : Nivolumab + Relatlimab Dose 1
干预措施: Nivolumab (Biological)
Arm B : Nivolumab + Relatlimab Dose 1
干预措施: Relatlimab (Biological)
Arm C : Nivolumab + Relatlimab Dose 2
干预措施: Nivolumab (Biological)
Arm C : Nivolumab + Relatlimab Dose 2
干预措施: Relatlimab (Biological)
结局指标
主要结局
Objective Response Rate(ORR) Assessed by BICR
时间窗: From randomization to primary completion date (Approximately 29.5 Months)
Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.
次要结局
- Disease Control Rate Assessed by BICR(From randomization to primary completion date (Approximately 29.5 Months))
- Duration of Response Assessed by BICR(From randomization to primary completion date (Approximately 29.5 Months))
- Progression Free Survival(PFS) Assessed by BICR(From randomization to primary completion date (Approximately 29.5 Months))
- Objective Response Rate Assessed by Investigator(From randomization to primary completion date (Approximately 29.5 Months))
- Disease Control Rate Assessed by Investigator(From randomization to primary completion date (Approximately 29.5 Months))
- Duration of Response Assessed by Investigator(From randomization to primary completion date (Approximately 29.5 Months))
- Progression Free Survival(PFS) Assessed by Investigator(From randomization to primary completion date (Approximately 29.5 Months))
- Overall Survival (OS)(From randomization to primary completion date (Approximately 29.5 Months))
- Number of Participants With Adverse Events(From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.)
- Number of Participants With Serious Adverse Events(From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.)
- Number of Participants With Adverse Events Leading to Discontinuation(From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.)
- Death Summary(From randomization to primary completion date (Approximately 29.5 Months))
- Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests(From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.)
- Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests(From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.)