A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 19
- 主要终点
- Number of Participants Experiencing Adverse Events
研究概览
简要总结
The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated
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
- None
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
- •12 years and older unless not permitted by local regulations; in that case 18 years old and older
- •Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1
- •Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition)
- •Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma)
- •Measurable disease per RECIST v1.1
排除标准
- •Active brain metastases or leptomeningeal metastases
- •Uveal or ocular melanoma
- •Participants with active, known, or suspected autoimmune disease
- •Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Nivolumab + BMS-986205
Specified dose on specified day.
Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion
干预措施: Nivolumab (Biological)
Nivolumab + Placebo
Specified dose on specified day
Participants will no longer receive BMS-986205 Placebo
干预措施: Nivolumab (Biological)
Nivolumab + Placebo
Specified dose on specified day
Participants will no longer receive BMS-986205 Placebo
干预措施: Placebo (Drug)
Nivolumab + BMS-986205
Specified dose on specified day.
Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion
干预措施: BMS-986205 (Drug)
结局指标
主要结局
Number of Participants Experiencing Adverse Events
时间窗: From first dose to 30 days following last dose (up to approximately 25 months)
Number of participants experiencing different types of Adverse Events, including Death, Any cause Adverse Events (AEs), Drug-related AEs, Any cause Serious Adverse Events (SAEs), Drug-related SAEs, SAEs leading to discontinuation, and Drug-related Non-serious AEs leading to discontinuation
次要结局
未报告次要终点