A randomised clinical trial investigating the effect of atezolizumab versus nil in Cohort 1 will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen
Studied treatment | Atezolizumab |
Control treatment | single arm study |
Patients | Cohort 1 will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen |
Group sizes | -9 / -9 |
Blindness | Inclusion period | ||
Follow-up duration | Centers | ||
Lost to FU | geographical localisation | ||
Primary endpoint | Design | Single-arm study |
phase 2
Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Durán Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet 2017;389:67-76 [PMID: 27939400] link to pdf add to Mendeley
ClinicalTrial.gov record NCT02951767
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