Patologia: Carcinoma della vescica
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: III
Richiesta mandatoria di tessuto: Sì
Linee di trattamento: Prima linea
Criteri di inclusione:
- Metastatic or inoperable urothelial cancer
- Must have at least 1 lesion with measurable disease
- Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
- No prior systemic chemotherapy treatment in the metastatic setting
Criteri di esclusione:
- Patients with disease that is suitable for local therapy administered with curative intent
- Patients with active brain metastases or leptomeningeal metastases
- Patients with active, known or suspected autoimmune disease
- Prior treatment with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137, or anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Other protocol defined inclusion/exclusion criteria could apply
Trattamento sperimentale:
- Investigational immunotherapy
Specified dose of nivolumab and ipilimumab on specified days
- Investigational immunotherapy
Specified dose of nivolumab plus gemcitabine-cisplatin followed by nivolumab only on specified days
Trattamento di controllo:
- Standard of care chemotherapy
Specified dose of gemcitabine / cisplatin or gemcitabine / carboplatin on specified days
- Standard of care chemotherapy
Specified dose of gemcitabine-cisplatin only on specified days
Obiettivi primari dello studio:
- Progression free survival (PFS) in cisplatin-ineligible participants using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: Up to 42 months ]
Measured by time Only applies to primary study
- Overall survival (OS) of cisplatin-ineligible participants [ Time Frame: Up to 42 months ]
Measured by time Only applies to primary study
- PFS based on BICR assessment of nivolumab combined with standard of care (SOC) chemotherapy to SOC chemotherapy in cisplatin-ineligible participants with previously untreated, unresectable or metastatic Urothelial Cancer (UC) [ Time Frame: Up to 42 months ]
Measured by time Only applies to sub-study
IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC
Riferimento: Dr. Ugo De Giorgi
IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
Riferimento: Dr. Andrea Necchi
Telefono: 0223902402
Email: andrea.necchi@istitutotumori.mi.it
Presidio Ospedaliero di Faenza
Viale Stradone 9 - 48018 Faenza - RA
Riferimento: Dr. Francesco Carrozza
Istituto Toscano Tumori Ospedale San Donato
Via Pietro Nenni 20 - 52100 Arezzo - AR
Riferimento: Dr.ssa Alketa Hamzaj
Email: alketa.hamzaj@uslsudest.toscana.it
A.U.S.L. 9 Grosseto
Via Senese - 58100 Grosseto - GR
Riferimento: Dr. Carmelo Bengala
Telefono: 0564485286
Email: carmelo.bengala@uslsudest.toscana.it
AORN Cardarelli
Via A Cardarelli 9 - 80131 napoli - NA
Riferimento: Dr. Giacomo Cartenì
Email: giacomo.carteni@aocardarelli.it
Numero di iscrizione a registro: 2016-003881-14
Data di inserimento: 11.04.2019
Bristol-Myers Squibb
NA
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Riferimento: Dr. Andrea Necchi
Telefono: 0223902402
Email: andrea.necchi@istitutotumori.mi.it
Localita: Milano