2023-508635-31-00招募中3 期
CA209-9DW - 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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 373
- 试验地点
- 42
- 主要终点
- OS, defined as the time between the date of randomization and the date of death (by any cause).
研究概览
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
OS, defined as the time between the date of randomization and the date of death (by any cause).
OS, defined as the time between the date of randomization and the date of death (by any cause).
次要结局
- ORR, defined as the percentage of participants whose BOR is either a confirmed CR or PR.
- DOR, defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression or death due to any cause, whichever occurs first
- TTSD, defined as the time from randomization until a clinically meaningful decline in the HCS subscale score of the FACT-Hep.
- PFS, defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
- TTP, defined as the time from randomization to the first documented disease progression.
研究者
GSM-CT
Scientific
Bristol Myers Squibb International Corporation
研究点 (42)
Loading locations...
相似试验
已完成
3 期
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular CarcinomaHepatocellular CarcinomaNCT04039607Bristol-Myers Squibb732
已完成
3 期
Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NeckHead and Neck CancerNCT02741570Bristol-Myers Squibb947
已完成
3 期
A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic MelanomaMelanomaNCT02714218Bristol-Myers Squibb387
进行中（未招募）
3 期
Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching BiomarkersRecurrent Squamous Cell Lung CarcinomaStage IV Squamous Cell Lung Carcinoma AJCC v7NCT02785952SWOG Cancer Research Network275
进行中（未招募）
3 期
Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE StudyClear Cell Renal Cell CarcinomaNCT03793166National Cancer Institute (NCI)1,175