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

abcorp Drug Development India Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•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 Ã¢â?°Â¥12weeks at Day 1

•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

abcorp Drug Development India Private Limited