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)

Description

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).This is a Phase III, randomised, open label, 3 arm, multi-centre, international study assessing the efficacy and safety of savolitinib plus durvalumab compared with sunitinib in participants with MET-driven (without co-occurring FH mutations), unresectable and locally advanced or metastatic PRCC, who have not received any prior systemic anti-cancer therapy in the metastatic setting. The study will also investigate the contribution of durvalumab to the savolitinib plus durvalumab combination. Approximately 200 participants will be randomised in a 2:1:1 ratio to one of the following intervention groups: savolitinib (600mg, oral, once daily) plus durvalumab (1500mg IV Q4W), sunitinib (50mg, oral, once daily for 4 consecutive weeks, followed by a sunitinib-free

Trial Eligibility

Inclusion 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 Exclusion Criteria: * 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

Study Info

Interventions

Locations Recruiting

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