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

AstraZeneca AB0 个研究点目标入组 200 人开始时间: 2021年6月29日最近更新: 2024年7月29日

适应症

试验速览

暂无简介。

•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

•History of liver cirrhosis of any origin and clinical stage; or history of
•other serious liver disease or chronic disease with relevant liver
•involvement, with or without normal LFTs
•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

发起方