jRCT2080224017已完成3 期
A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib Versus Sunitinib in Participants with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma (ONO-4538-81/CA2099ER)
ONO PHARMACEUTICAL CO.,LTD.1 个研究点目标入组 630 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 630
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- A Randomized, Open-label Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
- •Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
- •No prior systemic therapy for RCC with the following exception : One prior adjuvant or neo adjuvant therapy for completley resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if reccurence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
排除标准
- •Any active CNS metastases
- •Any active, known or suspected autoimmune disease
- •Any condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
结局指标
主要结局
-
efficacy Progression-free survival
次要结局
未报告次要终点
研究者
研究点 (1)
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