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

Roche

Status and phase: Completed; Phase 3

Conditions: Urinary Tract Cancer

Treatments: Drug: Atezolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02928406

MO29983

2016-002625-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,004 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,004 participants in 1 patient group

Atezolizumab

Experimental group

Description:

Participants will receive atezolizumab every 3 weeks (Q3W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).

Treatment:

Drug: Atezolizumab