Patients and treatments
tumor, pT4a, N0
TUMOR, RECURRENCE, ADVERSE EVENTS, DISEASE, URETER
Patients were eligible for the trial if they had undergone radical surgery (R0 with negative surgical margins) up to 120 days before randomization for pathologically confirmed MIUC arising in the bladder, ureter or renal pelvis and if they were considered at high risk of recurrence [pathological stage of pT3, pT4a or pN+ and patient not eligible for (Eligible patients were randomized to either nivolumab or placebo (1:1 ratio) with stratification by tumor PD-L1 expression (1% or more vs. less than 1%/indeterminate), pathological nodal status (N+ vs. N0 or NX with fewer than 10 nodes removed vs. N0 with 10 or more nodes removed) and cisplatin-based neoadjuvant chemotherapy (yes vs. no). Japanese was not included as a stratification factor. PD-L1 expression was determined using the PD-L1 IHC 28-8 pharmDx immunohistochemical assay (Dako).Patients were treated with 240 mg nivolumab or placebo every 2 weeks via intravenous infusion (30 min duration). Treatment was continued for up to 1 year or until discontinuation for disease recurrence. Dose delays or discontinuations were permitted if deemed necessary to manage adverse events (AEs).