CTIS2023-508264-29-00招募中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 - CA209-8Y8
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 448
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 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).
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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