NCT02575222已完成1 期
Phase I Study of Neoadjuvant Nivolumab in Patients With Non-metastatic High-risk Clear Cell Renal Cell Carcinoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Safety as assessed by number of participants experiencing adverse events
研究概览
简要总结
This study will evaluate the use of nivolumab before surgery in patients with high-risk clear cell renal cell carcinoma who are eligible for nephrectomy. Nivolumab is an antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nivolumab
Experimental
3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.
干预措施: Nivolumab (Drug)
结局指标
主要结局
Safety as assessed by number of participants experiencing adverse events
时间窗: From the first dose of nivolumab treatment through 100 days post-surgery
Number of participants experiencing any adverse event as defined by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
次要结局
- Objective Tumor Response Rate (by irRC)(Assessed at baseline, prior to surgery, and 3 months after surgery)
- Metastasis-Free Survival(12 months post-operatively, then every 6 months for 5 years)
- Objective Tumor Response Rate (by RECIST)(Assessed at baseline, prior to surgery, and 3 months after surgery)
- Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire(Baseline, 2 weeks, 4 weeks, prior to surgery, and at 1-, 3-, 6-, and 12-months after surgery)
- Overall Survival(12 months post-operatively, then every 6 months for 5 years)
研究者
研究点 (1)
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