EUCTR2016-000589-47-DK
进行中（未招募）
1 期
A Phase II Single-arm, Open-label Monotherapy Clinical Trial of Pembrolizumab (MK-3475) in Locally Advanced/Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-427) - Pembrolizumab in advanced renal cell carcinoma
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
- 入组人数
- 255
- 状态
- 进行中（未招募）
- 最后更新
- 3年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Be willing and able to provide written informed consent for the trial
- •\- Be \> or \= 18 years of age on day of signing informed consent
- •\- Cohort A (clear cell cohort) must have histologically confirmed diagnosis of clear cell RCC or RCC with clear cell component (with or without sarcomatoid features)
- •\- Cohort B (non\-clear cell cohort) must have histologically confirmed
- •diagnosis of non\-clear cell RCC (with or without sarcomatoid features)
- •by the site pathologist. For Cohort B, sites will submit tissues for
- •histologic confirmation of the diagnosis of non\-clear cell RCC by central
- •histology review during the screening phase. Sites should enroll subjects
- •in Cohort B after receiving notice
- •that the submitted tissue was adequate for central review. Confirmation
排除标准
- •\- Is currently participating in or has participated in a study of an
- •investigational agent or using an investigational device within 4 weeks
- •prior to allocation, has had major surgery within 4 weeks or radiation
- •therapy within 2 weeks prior to allocation, or who has not recovered
- •(i.e., \< or \= Grade 1 or at baseline) from adverse events due to prior
- •\- Had prior treatment with any anti\-PD\-1, or PD\-L1, or PD\-L2 agent or an
- •antibody targeting any other immune\-regulatory receptors or
- •mechanisms. Examples of such antibodies include (but are not limited
- •to) antibodies against IDO, PD\-L1, IL\-2R, GITR
- •\- Has a diagnosis of immunodeficiency OR is receiving a systemic steroid
结局指标
主要结局
未指定
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