NCT02388906已完成3 期
A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)
Bristol-Myers Squibb136 个研究点 分布在 4 个国家目标入组 906 人开始时间: 2015年3月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 906
- 试验地点
- 136
- 主要终点
- Recurrence-free Survival (RFS)
研究概览
简要总结
The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects < 18 years of age (pediatric population) to participate. For those sites, the eligible subject population is ≥ 18 years of age
- •Completely removed melanoma by surgery performed within 12 weeks of randomization
- •Stage IIIb/C or Stage IV before complete resection
- •No previous anti-cancer treatment
排除标准
- •Ocular or uveal melanoma
- •History of carcinomatosis meningitis
- •History of auto-immune disease
- •Treatment directed against the resected melanoma that is administrated after the surgery
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Ipilimumab and Placebo matching Nivolumab
Experimental
干预措施: Ipilimumab (Drug)
Ipilimumab and Placebo matching Nivolumab
Experimental
干预措施: Placebo matching Nivolumab (Other)
Nivolumab and Placebo matching Ipilimumab
Experimental
干预措施: Nivolumab (Drug)
Nivolumab and Placebo matching Ipilimumab
Experimental
干预措施: Placebo matching Ipilimumab (Other)
结局指标
主要结局
Recurrence-free Survival (RFS)
时间窗: up to 36 months
RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.
次要结局
- Overall Survival (OS)(up to 106.6 months)
- The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events(reported between first dose and 30 days after last dose of study therapy)
- The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events(reported between the first dose and 30 days after last dose of study therapy)
- the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths(reported between first dose and 30 to 100 days after last dose of study therapy)
- The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities(reported after first dose and within 30 days of last dose of the study therapy)
- Recurrence-free Survival by PD-L1 Expression(up to 106.6 months)
- Health Related Quality of Life (HRQoL) Evaluation(up to 36 months)
研究者
研究点 (136)
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