A Randomized, Blinded, Phase 2 Dose-Ranging Study Of BMS-936558 (MDX-1106) In Subjects With Progressive, Advanced/Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 76
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response relationship exists.
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
- •Histologic confirmation of Renal cell carcinoma (RCC) with a clear cell component
- •Previous treatment with at least one anti-angiogenic agent
- •Progressed within 6 months of study enrollment
- •Subjects should not have had more than 3 prior treatments for locally advanced or metastatic disease
- •Must have available tumor tissue for submission
- •Subjects must also meet various laboratory parameters for inclusion
排除标准
- •Subjects with any active autoimmune disease or a history of known autoimmune disease
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From randomization to disease progression or death (up to approximately 2 years)
PFS is defined as the time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator). Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.
次要结局
- Number of Participants Experiencing Adverse Events(From first dose to 30 days following last dose (up to approximately 6 years))
- Best Overall Response Rate (BORR)(From randomization until disease progression or discontinuation of study therapy (up to approximately 2 years))
- Overall Survival (OS)(From randomization to to date of death (up to approximately 8 years))