A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who Are Asymptomatic or Minimally Symptomatic
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 22
- 主要终点
- Radiographic Progression-free Survival (rPFS)
研究概览
简要总结
The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.
详细描述
Prostate Cancer Clinical Trials Working Group 2 (PCWG2)
Response Evaluation Criteria In Solid Tumors (RECIST)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Prostate cancer with metastases
- •Prostate cancer should be castration resistant
- •Progression during hormonal therapy
排除标准
- •Visceral metastases (eg liver, lung or brain metastases)
- •Prior treatment with any immunotherapy for prostate cancer
- •Prior or ongoing cytotoxic therapy for prostate cancer
- •Autoimmune disease
- •Inadequate hematologic, renal, or hepatic function
研究组 & 干预措施
Arm 1: Ipilimumab 3 mg/kg
Ipilimumab 3 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose
干预措施: Ipilimumab (Drug)
Arm 2: Ipilimumab 10 mg/kg
Ipilimumab 10 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Radiographic Progression-free Survival (rPFS)
时间窗: From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months)
rPFS was defined as the time from the date of randomization until the date of disease progression based on radiographic evidence and/or death from any cause, whichever occurs first. Radiographic disease progression is defined as: Confirmed bone disease progression according to criteria adapted from the Prostate Cancer Clinical Trials Working Group 2 (PCWG2), OR Non-bone disease progression according to the modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported radiographic progression is shown.
次要结局
- Overall Survival (OS)(From randomization to death from any cause (assessed up to December 2016, approximately 24 months))
- Prostate Specific Antigen Progression-free Survival (PSA PFS)(From randomization to the earliest date of PSA progression or death, whichever comes earlier (assessed up to December 2016, approximately 24 months))
- Number of Participants Who Experienced Immune-related Adverse Events (irAEs)(From first dose of ipilimumab to last dose plus 90 days)
- Time to Pain Progression(From randomization until pain progression (assessed up to December 2016, approximately 24 months))
- Prostate Specific Antigen Response Rate(From baseline to PSA response (assessed up to December 2016, approximately 48 months))