Phase 1 Study of Sipuleucel-T and Ipilimumab in Combination for Advanced Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Antigen-specific memory T cell response
研究概览
简要总结
This is a clinical trial designed to quantify the immune response and determine the tolerability and side effects of sipuleucel-T when given in combination with ipilimumab for patients with advanced prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subjects with advanced prostate cancer who are eligible to receive sipuleucel-T in accordance with FDA approved labeling of sipuleucel-T
- •Subjects must understand and sign an informed consent form
排除标准
- •Subjects who are not eligible to receive sipuleucel-T
研究组 & 干预措施
Treatment
Patients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab.
干预措施: sipuleucel-T (Drug)
Treatment
Patients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab.
干预措施: ipilimumab (Drug)
结局指标
主要结局
Antigen-specific memory T cell response
时间窗: After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months
To quantify antigen-specific memory T cell response to sipuleucel-T and ipilimumab in combination.
Antigen-specific T cell proliferation to PA2024, PAP and PHA
时间窗: After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months
To quantify Antigen-specific T cell proliferation to PA2024, PAP and PHA when sipuleucel-T and ipilimumab are given in combination. * PA2024 is a recombinant protein * PAP: Prostatic acid phosphatase * PHA: Phytohaemagglutinin, an assay control
Antibody responses against PA2024 and PAP
时间窗: After last sipuleucel-T and last ipilimumab, and the follow-up period, an expected average of 15 months
To quantify antibody responses against PA2024 and PAP. * PA2024 is a recombinant protein * PAP: Prostatic acid phosphatase
次要结局
- Prostate-Specific Antigen (PSA) doubling time(Duration of the study, an expected average of 18 months)
- Time to PSA progression(Duration of the study, an expected average of 18 months)
- Time to salvage therapy(Duration of the study, an expected average of 18 months)
- Percentage PSA decline(Duration of the study, an expected average of 18 months)