SAMETA - 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 (D5086C00001).

Studio Clinico

Patologia: Tumori del rene

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Prima linea

Criteri di inclusione: 

- 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.

Criteri di esclusione: 

- 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.

Schema di trattamento: 

Experimental: Arm A
savolitinib 600mg plus durvalumab 1500mg

Active Comparator: Arm B
sunitinib 50mg

Experimental: Arm C
durvalumab 1500mg.

Trattamento sperimentale: 

savolitinib + durvalumab

Trattamento di controllo: 

sunitinib

Obiettivi primari dello studio: 

Progression-Free Survival (PFS) /savolitinib plus durvalumab relative to sunitinib.

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-000336-55 - NCT05043090

Data di inserimento: 19.12.2023

Promotore

AstraZeneca

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd