A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg Versus at 10 mg /kg in Subjects With Previously Treated or Untreated Unresectable or Metastatic Melanoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 831
- 试验地点
- 88
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg
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
- All
- 接受健康志愿者
- 否
入选标准
- •For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
- •Inclusion Criteria:
- •Unresectable Stage III or Stage IV melanoma
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Brain metastases with symptoms or requiring treatment
- •History of autoimmune disease
研究组 & 干预措施
Arm 2: Ipilimumab (10 mg/kg)
Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity
干预措施: Ipilimumab (Biological)
Arm 1: Ipilimumab (3 mg/kg)
Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity
干预措施: Ipilimumab (Biological)
结局指标
主要结局
Overall Survival (OS)
时间窗: Approximately 48 months (assessed up to February 2016)
OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median and associated 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley.
次要结局
- Progression Free Survival (PFS) by mWHO Criteria(From date of randomization until 540 death events occurred (approximately 48 months))
- Duration of Response (DOR) by mWHO Criteria(From date of randomization until 540 death events occurred (approximately 48 months))
- Duration of Stable Disease by mWHO Criteria(From date of randomization until 540 death events occurred (approximately 48 months))
- Best Overall Response Rate (BORR) by mWHO Criteria(From date of randomization until 540 death events occurred (approximately 48 months))
- Disease Control Rate (DCR) by mWHO Criteria(From date of randomization until 540 death events occurred (approximately 48 months))
- Rate of Overall Survival(Approximately 66 months)
- Overall Survival of Participants With Brain Metastases at Baseline(From date of randomization until 540 death events occurred (approximately 48 months))