EURURO Vol. 72 No. 3

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Table 1 – Characteristics of randomized clinical trials on immune checkpoint inhibitors in urological cancer
Trial
Studydesign
Population Patients (
n
) Histology subgroups Line
Previous therapy
Experimental arm
Comparator
Urothelial cell cancerBellmunt et al (2017)
[23]
eynote-045
NCT02256436
Phase 3 Advanced UCC
542
Pembrolizumab 68.9%and chemotherapy 73.0%pure transition cellfeatures
Second Platinum-based
chemotherapy
200 mg pembrolizumab IV,every 3 wk
Investigator’s choice ofchemotherapy
Renal cell cancerMotzer et al (2015)
[26]
CheckMate 025NCT01668784
Phase 3 Advanced
and metastatic RCC
821
100% clear cell RCC
Second Antiangiogenic therapy 3 mg/kg nivolumab IV, every
2 wk
10 mg everolimus,orally, once daily
Motzer et al (2015)
[25]
NCT01354431 Phase 2 Metastatic RCC
168
100% clear cell RCC
Second Antiangiogenic therapy 0.3, 2, or 10 mg/kg nivolumab
IV, every 3 wk
Other experimentalarms
Choueiri et al (2016)
[24]
NCT01358721 Phase 1b Metastatic RCC
91
100% clear cell RCC
First,second
Systemic therapy, notspecified
0.3, 2, or 10 mg/kg nivolumab,every 3 wk
Other experimentalarms
Prostate cancerBeer et al (2017)
[27]
NCT01057810 Phase 3 mCRPC
602
NA
Second Antiandrogenic therapy,
no chemotherapy formCRPC
10 mg/kg ipilimumab IV, every3 wk for up to four doses,followed by maintenancetreatment every 12 wk
Placebo IV, every 3 wkfor up to four doses,followed bymaintenance treatmentevery 12 wk
Kwon et al (2014)
[28]
NCT00861614 Phase 3 mCRPC
799
Adenocarcinoma
Second Antiandrogenic therapy,
docetaxel-basedchemotherapy for mCRPC
Single-dose bone-directedradiotherapy (8 Gy) followed by10 mg/kg ipilimumab IV, every3 weeks for up to 4 doses
Single-dose bone-directed radiotherapy(8 Gy) followed byplacebo IV, every 3 wkfor up to four doses
UCC = urothelial cell cancer; RCC = renal cell cancer; mCRPC = metastatic castration-resistant prostate cancer; NA = not available; IV = intravenously.a
Previously treated population is subdivided into three dosage subgroups of 0.3, 2, or 10 mg/kg nivolumab; all treatment-naive patients received 10 mg/kg nivolumab.
E U R O P E A N U R O L O G Y 7 2 ( 2 0 1 7 ) 4 1 1 – 4 2 3 415