A Study to Investigate The Effectiveness Of Atezolizumab In Patients With Inoperable Locally-Advanced Or Metastatic Urothelial Carcinoma Of The Urinary Tract (Announce)

NCT ID: NCT03399643

Last Updated: 2019-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-28

Study Completion Date

2019-01-28

Brief Summary

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The objective of this study is to investigate the effectiveness of Atezolizumab with a primary focus on the overall survival (OS) rate at 2 years and secondary focuses on quality of life (QoL) and the sequence of treatment in mUC patients. Furthermore, this study aims at collecting data on safety of Atezolizumab and on the reason for cisplatin-ineligibility

Detailed Description

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Conditions

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Urothelial Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Atezolizumab

Atezolizumab is administered via IV 1200 mg every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Metastatic UC (Urothelial Carcinoma) including cancers of the renal pelvis, ureters, urinary bladder, and urethra
* Will be receiving atezolizumab for the treatment of inoperable locally-advanced or metastatic UC, per the decision of the treating physician
* Have adequate hematologic and end-organ functions
* Have had no prior palliative chemotherapy for inoperable locally-advanced or metastatic UC and are clinically ineligible ("unfit") for cisplatin-based chemotherapy

Exclusion Criteria

* Have received prior immune checkpoint therapy
* Are pregnant or breastfeeding
* Are included in any other trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Praxis Dr.med. Wolfgang Hölzer

Berlin, , Germany

Site Status

Urologie Schlosscarree

Braunschweig, , Germany

Site Status

Urologische Praxis Dr. Krieger

Chemnitz, , Germany

Site Status

Zeisigwaldkliniken Bethanien

Chemnitz, , Germany

Site Status

St. Georg Klinikum Eisenach GmbH

Eisenach, , Germany

Site Status

St. Franziskus-Hospital; Malteser Krankenhaus; Medizinische Klinik I

Flensburg, , Germany

Site Status

Klinikum Frankfurt Höchst GmbH; Klinik Innere Medizin 3 - Hämatologie, Onkologie, Palliativmedizin

Frankfurt am Main, , Germany

Site Status

Dres.Jochen Wilke und Harald Wagner

Fürth, , Germany

Site Status

Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

Halle, , Germany

Site Status

Urologische Praxis Michael Steinacker

Halle, , Germany

Site Status

Asklepios Klinik Altona, Abteilung für Urologie

Hamburg, , Germany

Site Status

Onkologische Praxis in Heidenheim

Heidenheim, , Germany

Site Status

St. Bernward-Krankenhaus

Hildesheim, , Germany

Site Status

Onkologische Praxis Landshut

Landshut, , Germany

Site Status

Gemeinschaftspraxis; Onkologisches Zentrum Lebach; Caritas Krankenhaus Lebach

Lebach, , Germany

Site Status

ÜBAG MVZ Mitte / MVZ Delitzsch GmbH, Standort Leipzig

Leipzig, , Germany

Site Status

Sankt Elisabeth Krankenhaus; Urlogische Abt.

Leipzig, , Germany

Site Status

Drk Krankenhaus Luckenwalde

Luckenwalde, , Germany

Site Status

Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Urologie

Lübeck, , Germany

Site Status

Urologikum Lübeck

Lübeck, , Germany

Site Status

Urologischen Praxis in Lüneburg

Lüneburg, , Germany

Site Status

Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie

Mannheim, , Germany

Site Status

Praxis Markkleeberg

Markkleeberg, , Germany

Site Status

Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Hämatologie, Onkologie und Pallia.

Minden, , Germany

Site Status

Städt.Kliniken München GmbH Klinikum Bogenhausen

München, , Germany

Site Status

Praxis Dr. Uhlig, Naunhof

Naunhof, , Germany

Site Status

Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie/Onkologie

Paderborn, , Germany

Site Status

Praxis für Hämatologie & Onkologie

Saarbrücken, , Germany

Site Status

MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken

Stade, , Germany

Site Status

Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie

Trier, , Germany

Site Status

Urologische Praxis

Wedel, , Germany

Site Status

Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede Aurich Rhauder

Westerstede, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ML39704

Identifier Type: -

Identifier Source: org_study_id

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