NCT03470922进行中（未招募）2 期
A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma
Bristol-Myers Squibb127 个研究点 分布在 7 个国家目标入组 714 人开始时间: 2018年4月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 714
- 试验地点
- 127
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab monotherapy in treating unresectable melanoma or melanoma that has spread.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
- •Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
- •Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
排除标准
- •Participants must not have active brain metastases or leptomeningeal metastases
- •Participants must not have uveal melanoma
- •Participants must not have an active, known, or suspected autoimmune disease
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Arm A: Relatlimab + Nivolumab
Experimental
Combination
干预措施: Relatlimab (Biological)
Arm A: Relatlimab + Nivolumab
Experimental
Combination
干预措施: Nivolumab (Biological)
Arm B: Nivolumab
Experimental
Monotherapy
干预措施: Nivolumab (Biological)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From randomization to date of first documented tumor progression or death (up to approximately 33 months)
Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.
次要结局
- Overall Response Rate (ORR)(From randomization up to approximately 3 years)
- Overall Survival (OS)(From randomization to the date of death (up to approximately 3 years))
研究者
研究点 (127)
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