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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

NCT02928406

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Urinary Tract Cancer

Interventions: Atezolizumab

Countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (175)
  • Buenos Aires, Argentina
  • Caba, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Canberra, Australian Capital Territory, Australia
  • Macquarie Park, New South Wales, Australia
  • Randwick, New South Wales, Australia
  • St Leonards, New South Wales, Australia
  • Waratah, New South Wales, Australia
  • South Brisbane, Queensland, Australia
  • Adelaide, South Australia, Australia
  • Hobart, Tasmania, Australia
  • Box Hill, Victoria, Australia
  • Heidelberg, Victoria, Australia
  • Innsbruck, Austria
  • Linz, Austria
  • Salzburg, Austria
  • Vienna, Austria
  • Vienna, Austria
  • Brussels, Belgium
  • Brussels, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Fortaleza, Ceará, Brazil
  • Curitiba, Paraná, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Barretos, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • + 145 more on CT.gov