NCT03444766已完成4 期
Safety Study of Nivolumab for Selected Advanced Malignancies in India
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年3月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-related Adverse Events
研究概览
简要总结
This is a study of nivolumab in participants with advanced Non-Small Cell Lung Cancer or Kidney Cancer in India.
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
- •Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy OR advanced renal cell carcinoma (RCC) after prior therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- •Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to randomization
排除标准
- •Participants with untreated, symptomatic central nervous system (CNS) metastases
- •Participants with carcinomatous meningitis
- •Participants with active, known or suspected autoimmune disease
- •Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
- •Other active malignancy requiring concurrent intervention
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Monotherapy
Experimental
administering nivolumab only
干预措施: Nivolumab (Drug)
结局指标
主要结局
Number of Participants With Treatment-related Adverse Events
时间窗: 26 Weeks
Number of participants with treatment-related Adverse Events based on worst ctc grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
次要结局
- Number of Participants With Treatment-related Select Adverse Events(26 Weeks)
- Number of Participants With Treatment-related Serious Adverse Events(26 Weeks)
- Number of Participants With Adverse Events Leading to Discontinuation(26 Weeks)
研究者
研究点 (1)
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