EAU 2017: A national, prospective, non-interventional study (NIS) of nivolumab (BMS-936558) in patients with advanced renal cell carcinoma after prior therapy

London, England (UroToday.com) Nivolumab was the first immune checkpoint inhibitor approved for the treatment of renal cell carcinoma (RCC). Nivolumab is a fully human IgG4 monoclonal antibody that targets the programmed death-1 (PD-1) receptor on activated immune cells. Real-world data is needed to demonstrate effectiveness and to monitor the occurrence and treatment of immune related adverse events.

This is a non-interventional, national, prospective, observational, multicenter study monitoring nivolumab therapy in RCC. In total, 323 patients diagnosed with advanced RCC with clear-cell and non-clear cell histology, who start new systemic therapy with nivolumab within the market authorization approval according to the label, will be enrolled. Data from approximately 50 oncology care facilities in Germany will be collected. Patients will be followed for a duration of 5 years from index date until death, withdrawal of consent, loss of follow-up, or to end of the study, whichever comes first.

During the follow-up period, assessment schedules will be performed according to routine local clinical practice. Data collection will take place at D0, W6, M3, M6, M9, M12, M24, M36, M48, and M60. The primary objective is overall survival over a 5 year follow-up period. Secondary objectives include progression free survival, response rates, patient characteristics, safety profiles, treatment patterns and patient-reported outcomes.

Presented by: Grimm M-O., Gr├╝nwald V., Bedke

Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto
Twitter: @GoldbergHanan

at the #EAU17 -March 24-28, 2017- London, England