A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to
 fourth-line treatment for participants with locally advanced or metastatic urothelial or
 non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of
 atezolizumab and potential tumor biomarkers associated with atezolizumab.
Inclusion Criteria:

 -  Participants with histologically documented locally advanced (tumor [T] 4b, any node
 [N]; or any T, N 2-3) or metastatic (M1, Stage IV) urothelial or non-urothelial
 carcinoma of the urinary tract

 -  Participants with measurable and/or non-measurable disease according to RECIST v1.1

 -  Participants must have progressed during or following treatment with at least one
 prior (and not more than 3) treatments for inoperable, locally advanced or metastatic
 urothelial or non-urothelial carcinoma of the urinary tract

 -  If available, a representative formalin-fixed paraffin-embedded (FFPE) tumor specimen
 block should be submitted

 -  Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2

 Exclusion Criteria:

 -  Treatment with more than three prior lines of systemic therapy for inoperable, locally
 advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract

 -  Treatment with any other investigational agent or participation in another clinical
 trial with therapeutic intent within 4 weeks prior to study treatment initiation

 1. Participants who were in another clinical trial with therapeutic intent within 4
 weeks of study treatment initiation but were not on active drug in that prior
 trial are eligible

 2. Participants who were in another clinical trial with therapeutic intent within 4
 weeks of study treatment initiation but were in the follow-up phase of that prior
 trial and had stopped receiving active drug 4 or more weeks before study
 treatment initiation are eligible

 -  Malignancies other than the one studied in this protocol within 5 years prior to Cycle
 1, Day 1

 -  Evidence of significant uncontrolled concomitant disease that could affect compliance
 with the protocol

 -  Significant renal disorder indicating a need for renal transplant