EUCTR2020-003655-15-FR进行中（未招募）1 期
A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy. - A Study of Subcutaneous Nivolumab in Previously Treated Advanced or Metastatic Clear Cell Renal Cell
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
- 458
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
- •- Histological confirmation of renal cell carcinoma (RCC)
- •- Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC (Stage IV)
- •- Measurable disease as defined by Response Evaluation Criteria in Solid Tumor
- •- Received no more than 2 prior systemic treatment regimens
- •- Progression or intolerance on or after the last treatment regimen received
- •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 275
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 183
排除标准
- •- Untreated, symptomatic central nervous system (CNS) metastases.
- •- Prior immunotherapy (medications which are target the immune system) known as PDL1 or CTLA4 or any other medications working similarly Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization
- •- Active, known, or suspected autoimmune disease
研究者
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