NCT01057810已完成3 期
Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer
Bristol-Myers Squibb44 个研究点 分布在 3 个国家目标入组 837 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 837
- 试验地点
- 44
- 主要终点
- Overall Survival (OS) Time
研究概览
简要总结
The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo
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
- •Metastatic prostate cancer
- •Asymptomatic or minimally symptomatic
- •Progression during hormonal therapy
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
排除标准
- •Liver, lung or brain metastases
- •Prior immunotherapy or chemotherapy for metastatic prostate cancer
- •Autoimmune disease
- •HIV, Hepatitis B, or Hepatitis C infection
研究组 & 干预措施
Ipilimumab
Experimental
干预措施: Ipilimumab (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival (OS) Time
时间窗: Randomization until death from any cause, up to April 2015, approximately 57 months
OS was defined as the time from the date of randomization until the date of death. For participants without documentation of death, OS was censored at the last date the participant was known to be alive.
次要结局
- Progression-Free Survival (PFS) Time(Randomization until disease progression, up to April 2015, approximately 57 months)
- Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities(Randomization up to April 2015, approximately 57 months)
- Time to Pain Progression(Randomization until pain progression, up to April 2015, approximately 57 months)
- Time to Subsequent Non-hormonal Cytotoxic Therapy(Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months)
- Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)(Day 1 of study therapy to last dose plus 70 days)
研究者
研究点 (44)
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