A Phase 3, Randomized Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,844
- 试验地点
- 192
- 主要终点
- Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1%
研究概览
简要总结
The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of participation in study.
- •Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
- •No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions)
排除标准
- •History of uveal melanoma
- •Patients with active, known or suspected autoimmune disease
- •Prior treatment with interferon (if complete < 6 months prior to participation in study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1%
时间窗: From randomization to Primary Completion Date (up to approximately 3 years)
RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first. Median based on Kaplan-Meier Estimates.
Recurrence-free Survival (RFS) - All Randomized Participants
时间窗: From randomization to Primary Completion Date (up to approximately 3 years)
RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first. Median values based on Kaplan-Meier Estimates.
次要结局
- Overall Survival (OS) - All Randomized Participants(From randomization to date of death (up to approximately 45 months))
- Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%(From randomization to date of death (up to approximately 45 months))
- Time From Next Therapy to Second Next Therapy - All Randomized Participants With PD-L1 Expression Level < 1%(From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months))
- Time to Next-Line Therapies - All Randomized Participants(From randomization to start of next therapy or second next therapy (up to approximately 45 months))
- Time From Next Therapy to Second Next Therapy - All Randomized Participants(From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months))
- Time to Next-Line Therapies - All Randomized Participants With PD-L1 Expression Level < 1%(From randomization to start of next therapy or second next therapy (up to approximately 45 months))
- Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants(From randomization to progression event (up to approximately 45 months))
- Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression(From randomization to Study Completion Date (up to approximately 45 months))
- Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1%(From randomization to progression event (up to approximately 45 months))