An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 462
- 主要终点
- Overall Survival
研究概览
简要总结
This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
详细描述
This study will investigate the combination of an autologous ribonucleic acid (RNA) electroporated dendritic cell (DC) based immunotherapy, AGS-003, plus standard treatment (initiating with sunitinib). The primary objective in this study is to determine the median OS achieved by this combination compared to the OS resulting from use of active control (standard treatment), in a population of adults with advanced renal cell carcinoma (RCC), with nephrectomy indicated, and with remaining metastatic disease.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AGS-003 + Standard Treatment
Subjects on this arm will receive standard treatment for Renal Cell Carcinoma. In addition, subjects will receive AGS-003.
干预措施: AGS-003 (Biological)
Standard Treatment
Subjects on this arm will receive standard treatment for Renal Cell Carcinoma.
干预措施: Standard Treatment (Drug)
结局指标
主要结局
Overall Survival
时间窗: From date of subject randomization to date of death; assessed up to 42 months or until 290 deaths have been accrued on study
Duration from randomization to death
次要结局
- Progression Free Survival(From date of subject randomization to date of progression; assessed up to 42 months)
- Monitor treatment emergent adverse events between both arms(From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months)
- Tumor Response(From date of subject randomization to date of progression; assessed up to 42 months)