EUCTR2021-000336-55-ES进行中（未招募）1 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) - SAMETA
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
- 200
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
- •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
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
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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