A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 89
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.
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
- •Participant has intermediate-stage hepatocellular carcinoma (HCC) whose tumor characteristics exceed the Beyond Milan and Up-to-7 (BMU7) criteria and is eligible for trans-arterial ChemoEmbolization (TACE)
- •Participant has no extrahepatic spreading (EHS), no regional lymph node involvement, no main, left main, or right main portal vein thrombosis, and no macrovascular invasion (MVI)
- •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 or participants who are on the waiting list for liver transplantation
- •Active, known, or suspected autoimmune disease
- •Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Nivolumab + Ipilimumab + TACE
TACE (Trans-arterial ChemoEmbolization)
干预措施: nivolumab (Drug)
Nivolumab + Ipilimumab + TACE
TACE (Trans-arterial ChemoEmbolization)
干预措施: ipilimumab (Drug)
Nivolumab + Ipilimumab + TACE
TACE (Trans-arterial ChemoEmbolization)
干预措施: TACE (Procedure)
Nivolumab + TACE
干预措施: nivolumab (Drug)
Nivolumab + TACE
干预措施: TACE (Procedure)
TACE
干预措施: TACE (Procedure)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Number of Participants With Serious Adverse Events (SAEs)
时间窗: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose that results in death, Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) or requires inpatient hospitalization or causes prolongation of existing hospitalization, or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event.
Number of Participants Who Died
时间窗: From first dose and 100 days after last dose of study therapy (up to approximately 27 months)
Number of participants who died due to any cause are summarized.
Number of Participants With Adverse Events Leading to Study Drug Discontinuation
时间窗: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
时间窗: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening). Highest grade measured for hemoglobin and albumin was Grade 3.
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
时间窗: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Blood samples were collected for specific thyroid test.
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
时间窗: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Blood samples were collected for specific liver tests.
次要结局
未报告次要终点