NCT02754141已完成1 期
A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors
Bristol-Myers Squibb47 个研究点 分布在 7 个国家目标入组 235 人开始时间: 2016年6月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 235
- 试验地点
- 47
- 主要终点
- Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
研究概览
简要总结
The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective)
- •Eastern Cooperative Oncology Group (ECOG) 0-1
- •Acceptable lab testing results
- •Allow biopsies
排除标准
- •Central nervous system (CNS) tumors
- •Uncontrolled or significant cardiovascular diseases
- •Active or known autoimmune disease
- •Organ transplant
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
时间窗: From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.
Number of participants with drug related adverse events (AE), drug related serious adverse events (SAE), drug related AEs Leading to discontinuation and drug related deaths
次要结局
- Cmax(Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days)
- Tmax(Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days)
- Median Duration of Response (DOR)(from first measure response approximately up to 25 months)
- Progression Free Survival Rate (PFSR) at Week 24(from initial treatment to week 24)
- Number of Participants With a Best Overall Response (BOR) at Week 24(from initial treatment to week 24)
- AUC (0-T)(Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days)
- Percentage of Participants With an Objective Response Rate (ORR) at Week 24(from initial treatment to week 24)
- AUC (Tau)(Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days)
- Mean Change From Baseline in CD73 Assays(approximately up to 95 weeks)
- Number of Participants With a Positive Anti-drug Antibody (ADA) Test.(From first dose to last dose: Part 1: up to 95 weeks, Part 2 SC: up to 62 weeks, RCC Mono: up to 108 weeks, Part 2: up to 104 weeks)
- Ctau(Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days)
研究者
研究点 (47)
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