Groupe d'Etude en Oncologie du Quebec

Titre	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
Protocole ID	SAMETA
ClinicalTrials.gov ID	NCT05043090
Type(s) de cancer	Rein
Phase	Phase III
Stade	Maladie avancée ou métastatique
Type étude	Clinique
Médicament	Savolitinib + durvalumab versus sunitinib
Institution	CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS 3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
Ville	Montréal
Investigateur(trice) principal(e)	Dr Wilson Miller
Coordonnateur(trice)	Ivgenya Kosenko 514-340-8222 poste 25981
Statut	Actif en recrutement
Date d'activation	12-10-2022
Critètes d'éligibilité	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
Critètes d'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

Groupe d'étude en oncologie du Québec