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A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer - CA209-901

Studio Clinico

Patologia: Carcinoma della vescica

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

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

Centri partecipanti

Nord Italia

IRCCS - IRST
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

 

Centro Italia

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

 

Sud Italia e isole

AORN Cardarelli
Via A Cardarelli 9 - 80131 napoli - NA

Riferimento: Dr. Giacomo Cartenì
Email: giacomo.carteni@aocardarelli.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2016-003881-14

Data di inserimento: 11.04.2019

Promotore

Bristol-Myers Squibb

CRO

NA

Principal Investigator ITALIA

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Riferimento: Dr. Andrea Necchi

Telefono: 0223902402

Email: andrea.necchi@istitutotumori.mi.it

Localita: Milano

 

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