NCT05337137已完成1 期
A Phase 1/2, Safety Confirmation, Placebo-controlled, Randomized Study of Nivolumab in Combination With Relatlimab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma
Bristol-Myers Squibb119 个研究点 分布在 14 个国家目标入组 83 人开始时间: 2022年5月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 119
- 主要终点
- Incidence of dose-limiting toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic 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
- Triple (Participant, Care Provider, Investigator)
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/metastatic hepatocellular carcinoma (HCC)
- •Naïve to systemic therapy for advanced/metastatic HCC (prior neo-adjuvant or adjuvant immunotherapy is permitted if recurrence occurs ≥ 6 months after treatment completion and the case is discussed with BMS medical team)
- •Child-Pugh score of 5 or 6 (ie, Child-Pugh A)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
- •Prior allogenic stem cell or solid organ transplantation
- •Untreated symptomatic central nervous system (CNS) metastases
- •Clinically significant ascites as defined by:
- •i) Prior ascites that required treatment and requires on-going prophylaxis, or ii) Current ascites requiring treatment
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm B: Placebo + Nivolumab + Bevacizumab
Experimental
干预措施: Nivolumab (Drug)
Arm A: Relatlimab + Nivolumab + Bevacizumab
Experimental
干预措施: Relatlimab (Drug)
Arm A: Relatlimab + Nivolumab + Bevacizumab
Experimental
干预措施: Nivolumab (Drug)
Arm A: Relatlimab + Nivolumab + Bevacizumab
Experimental
干预措施: Bevacizumab (Drug)
Arm B: Placebo + Nivolumab + Bevacizumab
Experimental
干预措施: Bevacizumab (Drug)
Arm B: Placebo + Nivolumab + Bevacizumab
Experimental
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs)
时间窗: Up to 6 weeks
Overall Response Rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
时间窗: Assessed up to 3 years
次要结局
- PFS by BICR per RECIST v1.1 in all randomized participants(Assessed up to 3 years)
- ORR by BICR per RECIST v1.1 in all randomized participants that are LAG-3 positive(Assessed up to 3 years)
- Progression Free Survival (PFS) by BICR per RECIST v1.1 in all randomized participants that are lymphocyte activation gene 3 (LAG-3) positive(Assessed up to 3 years)
- Overall Survival (OS) of all randomized participants(Assessed up to 3 years)
- OS of all randomized participants that are LAG-3 positive(Assessed up to 3 years)
- Number of participants with adverse events (AEs)(Up to 135 days after participant's last dose)
研究者
研究点 (119)
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