NL-OMON54072招募中3 期
A Phase III, Open Label, Randomised, 3 Arm, Multi Centre Study of Savolitinib plus Durvalumab versus Sunitinib and Durvalumab Monotherapy in Participants with MET Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC) - SAMETA
Astra Zeneca0 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 14
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 64（—）
入选标准
- •Histologically confirmed unresectable and locally advanced or metastatic PRCC
- •PRCC must be centrally confirmed as MET-driven using a sponsor-designated
- •central laboratory validated NGS assay
- •No prior systemic anti-cancer treatment in the metastatic setting; no prior
- •exposure to MET inhibitors, Durvalumab or Sunitinib in any setting
- •Karnofsky Score > 70
- •At least one lesion, not previously irradiated, that can be accurately
- •measured at baseline
- •Adequate organ and bone marrow function
- •Life expectancy >=12weeks at Day 1
排除标准
- •History of serious liver disease, with or without, normal LFTs, such as
- •cirrhosis or Wilson*s disease
- •Spinal cord compression or brain metastases, unless asymptomatic and stable
- •on treatment for at least 14 days prior to study intervention
- •Active or prior cardiac disease (within past 6 months) or clinically
- •significant ECG abnormalities and/or factors/medications that may affect QT
- •and/or QTc intervals
- •Active infection including HIV, TB, HBV and HCV
- •Active or prior documented autoimmune or inflammatory disorders
- •Receipt of live attenuated vaccine within 30 days prior to the first dose of
- •study intervention
研究者
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