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RecruitingLast updated: 20 February 2024

SAMETA: This trial is comparing three different types and combinations of targeted therapy for the treatment of papillary renal cell carcinoma that has spread locally or to distant locations in the bodyA Phase III, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (SAMETA)

Clinical summary

Summary

Eligible participants will be randomised in a 2:1:1 ratio to one of the following intervention groups: Group 1- savolitinib (600mg given orally, once daily) plus durvalumab (1500mg given intravenously, every 4 weeks), Group 2 - sunitinib (50mg given orally, once daily for 4 consecutive weeks, followed by a sunitinib-free interval of 2-weeks, every 6 weeks), or Group 4 - durvalumab monotherapy (1500mg given intravenously, every 4 weeks).

Conditions

This trial is treating patients with Papillary Renal Cell Carcinoma

Cancer

Urinary System Cancers Genitourinary

Age

People18 - 130

Phase

III

Trial Acronym

SAMETA

More information

Trial Identifiers

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Trial sponsor

AstraZeneca

Scientific Title

A Phase III, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (SAMETA)

Eligibility

Inclusion

  • 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

Exclusion

  • 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

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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