A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

• Status: Active, not recruiting
• Trial end date: 2022-03-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antibodies, Monoclonal; Atezolizumab

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