Study of Neoadjuvant Nivolumab in Patients With Non-metastatic Stage II-IV Clear Cell Renal Cell Carcinoma
2020年6月10日 更新者：Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase I Study of Neoadjuvant Nivolumab in Patients With Non-metastatic High-risk Clear Cell Renal Cell Carcinoma
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).
研究概览
研究类型
介入性
注册 (实际的)
17
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Maryland
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Baltimore、Maryland、美国、21287
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria (abbreviated):
- Confirmed non-metastatic high-risk clear cell renal cell carcinoma (T2a-T4NanyM0 or TanyN1M0)
- Schedule to undergo either partial or radical nephrectomy as part of treatment plan
- Patient agrees to have a tumor biopsy
- ECOG performance status of 0 or 1
- Adequate organ and marrow function defined by study-specified laboratory tests
- Must use acceptable form of birth control while on study and for approximately 31 weeks post-treatment completion
- Willingness and ability to comply with scheduled visits, treatment plans, lab tests and other study procedures
Exclusion Criteria (abbreviated):
- Other active malignancies within last 3 years (with some exceptions for skin, prostate, cervical, or breast cancer)
- Need for urgent or emergent nephrectomy to relieve symptoms
- Prior treatment for RCC including surgery, radiation, thermoablation or systemic therapy
- Surgery within 28 days of starting study treatment (some exceptions for minor procedures)
- Received live vaccine for infectious diseases within 28 days of starting study treatment
- Prior treatment with any antibody or drug targeting T-cell costimulation or immune checkpoint pathways (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc)
- Use of immunosuppressive doses of systemic medications within 14 days prior to starting study drug.
- Current use of immunosuppressive agents
- History of severe hypersensitivity reaction to other monoclonal antibodies
- Current signs or symptoms of severe progressive or uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC
- Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements.
- Active infection requiring therapy.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA).
- History of autoimmune disease or syndrome requiring systemic steroids or immunosuppressants (some exceptions apply).
- Pulse oximetry of <92% on room air
- Pregnant or breastfeeding women
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Nivolumab
3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.
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3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety as assessed by number of participants experiencing adverse events
大体时间：From the first dose of nivolumab treatment through 100 days post-surgery
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Number of participants experiencing any adverse event as defined by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
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From the first dose of nivolumab treatment through 100 days post-surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective Tumor Response Rate (by RECIST)
大体时间：Assessed at baseline, prior to surgery, and 3 months after surgery
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Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST)
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Assessed at baseline, prior to surgery, and 3 months after surgery
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Objective Tumor Response Rate (by irRC)
大体时间：Assessed at baseline, prior to surgery, and 3 months after surgery
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Number of patients achieving a complete response (CR) or partial response (PR) by immune-related response criteria (irRC)
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Assessed at baseline, prior to surgery, and 3 months after surgery
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Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire
大体时间：Baseline, 2 weeks, 4 weeks, prior to surgery, and at 1-, 3-, 6-, and 12-months after surgery
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Total score range 0-60 with higher scores indicating a less symptomatic respondent.
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Baseline, 2 weeks, 4 weeks, prior to surgery, and at 1-, 3-, 6-, and 12-months after surgery
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Metastasis-Free Survival
大体时间：12 months post-operatively, then every 6 months for 5 years
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Number of months without evidence of metastasis.
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12 months post-operatively, then every 6 months for 5 years
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Overall Survival
大体时间：12 months post-operatively, then every 6 months for 5 years
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Number of months alive.
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12 months post-operatively, then every 6 months for 5 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mohamad E Allaf, M.D、Department of Urology and The Brady Urological Institute at Johns Hopkins
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年2月1日
初级完成 (实际的)
2020年6月9日
研究完成 (实际的)
2020年6月9日
研究注册日期
首次提交
2015年10月6日
首先提交符合 QC 标准的
2015年10月13日
首次发布 (估计)
2015年10月14日
研究记录更新
最后更新发布 (实际的)
2020年6月12日
上次提交的符合 QC 标准的更新
2020年6月10日
最后验证
2020年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.