NCT02832167已完成2 期
An Open Label Phase 2 Multi-cohort Trial of Nivolumab in Advanced or Metastatic Malignancies
Bristol-Myers Squibb85 个研究点 分布在 2 个国家目标入组 239 人开始时间: 2016年2月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 239
- 试验地点
- 85
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to determine whether nivolumab is an effective treatment for cancer that has advanced or has spread. Various tumor types may be eligible for enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosed with advanced or metastatic malignancy
- •Received standard of care treatment for primary malignancy and standard of care treatment for relapsed cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Prior treatment with an antiPD1, antiPDL1, antiPDL2, antiCD137, or antiCTLA4 antibody, or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways.
- •Subjects previously treated with investigational anticancer therapies less than 6 weeks prior to the first dose of Nivolumab
- •Subjects with an active, known, or suspected autoimmune disease
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From first dose to the date of objectively documented progression (per tumor-specific response criteria) or the date of subsequent therapy, whichever occurs first (up to approximately 24 months)
ORR is defined as the percentage of participants with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR). Best overall response is defined as the best response designation, as determined by investigator, recorded in the specified timeframe, according to the RECIST 1.1 criteria.
次要结局
- Duration of Response (DOR)(From the time of first confirmed response to the date of the first documented progression (up to approximately 22 months))
- Time to Objective Response (TTR)(From the first dosing date to the date of the first confirmed response (up to approximately 10 months))
- Clinical Benefit Rate (CBR)(From the first dosing date to the date of the last dose (approximately 24 months))
- Overall Survival Rate at 1 Year(From the first dosing date to 1 year later)
- Number of Participants Who Died(From first dose to 100 days following last dose (up approximately 27 months))
- Number of Participants Experiencing Adverse Events (AEs)(From first dose to 30 days following the last dose (up to approximately 25 months))
- Number of Participants Experiencing Serious Adverse Events (SAEs)(From first dose to 100 days following the last dose (up to approximately 27 months))
- Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation(From first dose to 30 days following the last dose (up to approximately 25 months))
- Number of Participants Experiencing Immune-mediated Adverse Events (IMAEs)(From first dose to 100 days following the last dose (up to approximately 27 months))
- Number of Participants Experiencing Select Adverse Events(From first dose to 30 days following the last dose (up to approximately 25 months))
- Number of Participants Experiencing Adverse Events (AEs) Leading to Dose Delay or Dose Reduction(From first dose to 30 days following the last dose (up to approximately 25 months))
- Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests(From first dose to 30 days following the last dose (up to approximately 25 months))
- Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests(From first dose to 100 days following the last dose (up to approximately 27 months))
研究者
研究点 (85)
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