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A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT02928406•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (175)

Inst. Alexander Fleming; Oncologia

Buenos Aires, Argentina

Hospital Aleman

Caba, Argentina

Hospital Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Canberra Hospital; Medical Oncology

Canberra, Australian Capital Territory, Australia

Macquarie University Hospital

Macquarie Park, New South Wales, Australia

Prince of Wales Hospital; Oncology

Randwick, New South Wales, Australia

Northern Cancer Institute

St Leonards, New South Wales, Australia

Calvary Mater Newcastle; Medical Oncology

Waratah, New South Wales, Australia

Icon Cancer Foundation

South Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Key Dates

Start Date

November 30, 2016

Primary Completion Date

December 12, 2022

Completion Date

December 12, 2022

Last Updated

April 4, 2024

Enrollment

1,004

ACTUAL participants

Conditions

Urinary Tract Cancer

Interventions

Atezolizumab

DRUG

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COMPLETED

CLE Characteristics of Upper Urinary Tract Urothelial Carcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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