D5086C00001
A Phase 3, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib plus Durvalumab versus Sunitinib and Durvalumab Monotheraphy in Participants with MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC) (SAMETA)
Key Inclusion Criteria
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Have not received any prior systemic anti-cancer therapy in metastatic setting. (Prior exposure to MET inhibitors, durvalumab, or sunitinib in any setting is not permitted.)
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Centrally confirmed MET-driven PRCC without co-occurring FH mutations
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Mandatory provision of FFPE tumour sample
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Adequate organ and marrow functions
Key Exclusion Criteria
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Symptomatic Spinal cord compression or brain metastases
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Active HBV or HCV, eligible if resolved
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Active or prior documented autoimmune or inflammatory disorders
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Cardiac disease within last 6 months
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Significant COVID-19 illness within 6 months