Genitourinary Cancer

SAMETA (D5086C00001)

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

Study details

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)

Further information

Please click here for more information

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