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.
Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC
Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE
Arcispedale Santa Maria Nuova
AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR
AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI
AO S. Maria Terni
Via Tristano di Joannuccio 1 - 05100 Terni - TR
A.O.S.G. Moscati
Contrada Amoretta - 83100 Avellino - AV
Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA
Ospedale 'Card. G. Panico'
Via San Pio X 4 - 73039 Tricase - LE
AORN Cardarelli
Via A Cardarelli 9 - 80131 napoli - NA
Numero di iscrizione a registro: 2021-000336-55 - NCT05043090
Data di inserimento: 19.12.2023
AstraZeneca
Riferimento: Dr. Info non disponibile
Telefono: 00000
Email: nd@nd.it
Localita: nd