Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC

Prior treatment

• Spinal cord compression or brain metastases, unless asymptomatic and stable on treatment for at least 14 days prior to study intervention
• Active or prior documented autoimmune or inflammatory disorders
• Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention

Other illness

• 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
• Active infection including HIV, TB, HBV and HCV

Lab values

• 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

• 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