EUCTR2018-004695-35-PL进行中（未招募）1 期
A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined with Ipilimumab versus Nivolumab Monotherapy for Patients with Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors
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
- 518
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 carcinoma with clear cell component including participants who may have sarcomatoid features.
- •- Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC).
- •- Measurable disease by CT or MRI per RECIST 1.1 criteria.
- •- No prior systemic therapy for RCC
- •- Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC).
- •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 321
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 197
排除标准
- •- Any active central nervous system (CNS) metastases.
- •- Active, known, or suspected autoimmune disease
- •- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti CTLA-4 antibody, or any other agents specifically targeting T-cell co stimulation or checkpoint pathways
研究者
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