EUCTR2011-005132-26-CZ进行中（未招募）1 期
A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy+ Pharmacogenetics Blood Sample Amendment 01- dated 18-jun-12, version 1.0 - CheckMate 025: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 975
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Men & women = 18 years of age
- •2.Histologic confirmation of RCC with clear-cell component
- •3.Advanced/metastatic RCC
- •4.Measurable disease per RECIST 1.1 criteria
- •5.Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
- •6.No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment
- •7.Karnofsky Performance Score = 70%
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 585
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 390
排除标准
- •1.Any CNS metastases or history of CNS metastases
- •2.Prior therapy with an mTOR inhibitor
- •3.Any active known or suspected autoimmune disease.
- •4.Uncontrolled adrenal insufficiency
- •5.Active chronic liver disease
- •6.Prior malignancy active within past 3 years, except for locally curable cancers
研究者
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