Genitourinary Cancer
SAMETA (D5086C00001)
A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell Carcinoma)
Trial overview
Topic
Genitourinary Cancer
Description
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)
Eligibility criteria
- 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
Further information
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Location