An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract


Condition: Urinary Tract Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02928406

Sponsor: Hoffmann-La Roche

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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

View trial on ClinicalTrials.gov