NCT02596035已完成4 期
A Phase 3b/4 Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Renal Cell Carcinoma (CheckMate 374: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 374)
Bristol-Myers Squibb39 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2016年1月8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
- 197
- 试验地点
- 39
- 主要终点
- Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
研究概览
简要总结
This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Advanced or Metastatic renal cell carcinoma (RCC)
- •Predominant clear cell histology:
- •At least 1 but no more than 2 prior systemic anti vascular endothelial growth factor (anti-VEGF) treatments
- •No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting
- •Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are eligible
- •Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor
- •Brain metastases allowed if asymptomatic, without edema, and not receiving corticosteroids or radiation
- •Performance Status (PS): ≥ 70% Karnofsky Performance Scale (KPS)
- •All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed
排除标准
- •Subjects with any active autoimmune disease or a history of known autoimmune disease
- •History of severe hypersensitivity reaction to other monoclonal antibodies
- •Prior malignancy, active within the last 3 years, except for locally curable cancers which have been apparently cured
- •Known HIV or AIDS-related illness
- •Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic infection
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Nivolumab
Experimental
Nivolumab dose as specified
干预措施: Nivolumab (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
时间窗: Up to 100 days of the last dose of study drug (Approximately 2 years)
IMAEs were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 4.0 criteria by system organ class and MedDRA version 20.1 preferred term.
次要结局
- Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events(Up to 100 days of the last dose of study drug (Approximately 10 months up to 26 months))
- Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events(From onset of grade 3-5 IMAEs to resolution of IMAEs (Approximately 4 years and 7 months))
- Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)(Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months))
- Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event(Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months))
- Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event(From the initiation of Immune modulating medication to discontinuation (approximately 4 years and 9 months).))
- Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication(Up to 100 days of the last dose of study drug (Approximately 2 years))
研究者
研究点 (39)
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