A Randomized Phase II Study to Assess the Activity of TroVax® (MVA-5T4) Plus Docetaxel Versus Docetaxel Alone in Subjects With Progressive Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 7
- 主要终点
- Progression-free survival
研究概览
简要总结
Based on both pre-clinical and clinical data, it may be advantageous to administer a cancer vaccine before chemotherapy to enhance immune responses, thus leading to a more effective therapeutic approach for subjects with metastatic HRPC. This clinical study will evaluate the role of combination therapy of TroVax® plus Docetaxel vs. Docetaxel alone on the progression free survival (PFS) of subjects with HRPC.
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
- Male
- 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
Docetaxel Alone
Subjects will receive 10 cycles of Docetaxel alone until toxicity or progression.
干预措施: Docetaxel (Drug)
TroVax plus Docetaxel
Subjects will receive both TroVax plus 10 cycles of Docetaxel.
干预措施: Docetaxel (Drug)
TroVax plus Docetaxel
Subjects will receive both TroVax plus 10 cycles of Docetaxel.
干预措施: TroVax (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Week 37
To establish whether the incidence of progression-free survival (as defined by the absence of progression assessed by both RECIST and PCWG2 criteria) at week 37 in the TroVax® plus Docetaxel treatment arm is higher than the incidence in the Docetaxel alone treatment arm.
次要结局
- Clinical progression-free survival(37 weeks)