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

April 17, 2019 updated by: Hoffmann-La Roche

Non-Interventional Study To Investigate The Effectiveness Of Atezolizumab Under Real-World Conditions In Patients With Inoperable Locally-Advanced Or Metastatic Urothelial Carcinoma Of The Urinary Tract (Announce)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13055
        • Praxis Dr.med. Wolfgang Hölzer
      • Braunschweig, Germany, 38100
        • Urologie Schlosscarree
      • Chemnitz, Germany, 09130
        • Zeisigwaldkliniken Bethanien
      • Chemnitz, Germany, 09127
        • Urologische Praxis Dr. Krieger
      • Eisenach, Germany, 99817
        • St. Georg Klinikum Eisenach GmbH
      • Flensburg, Germany, 24939
        • St. Franziskus-Hospital; Malteser Krankenhaus; Medizinische Klinik I
      • Frankfurt am Main, Germany, 65929
        • Klinikum Frankfurt Höchst GmbH; Klinik Innere Medizin 3 - Hämatologie, Onkologie, Palliativmedizin
      • Fürth, Germany, 90766
        • Dres.Jochen Wilke und Harald Wagner
      • Halle, Germany, 06120
        • Urologische Praxis Michael Steinacker
      • Halle (Saale), Germany, 06120
        • Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
      • Hamburg, Germany, 22763
        • Asklepios Klinik Altona, Abteilung für Urologie
      • Heidenheim, Germany, 89522
        • Onkologische Praxis in Heidenheim
      • Hildesheim, Germany, 31134
        • St. Bernward-Krankenhaus
      • Landshut, Germany, 84036
        • Onkologische Praxis Landshut
      • Lebach, Germany, 66822
        • Gemeinschaftspraxis; Onkologisches Zentrum Lebach; Caritas Krankenhaus Lebach
      • Leipzig, Germany, 04103
        • ÜBAG MVZ Mitte / MVZ Delitzsch GmbH, Standort Leipzig
      • Leipzig, Germany, 04277
        • Sankt Elisabeth Krankenhaus; Urlogische Abt.
      • Luckenwalde, Germany, 14943
        • DRK Krankenhaus Luckenwalde
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Urologie
      • Lübeck, Germany, 23566
        • Urologikum Lübeck
      • Lüneburg, Germany, 21335
        • Urologischen Praxis in Lüneburg
      • Mannheim, Germany, 68167
        • Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie
      • Markkleeberg, Germany, 04416
        • Praxis Markkleeberg
      • Minden, Germany, 32429
        • Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Hämatologie, Onkologie und Pallia.
      • München, Germany, 81925
        • Städt.Kliniken München GmbH Klinikum Bogenhausen
      • Naunhof, Germany, 04683
        • Praxis Dr. Uhlig, Naunhof
      • Paderborn, Germany, 33098
        • Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie/Onkologie
      • Saarbruecken, Germany, 66113
        • Praxis für Hämatologie & Onkologie
      • Stade, Germany, 21680
        • MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
      • Trier, Germany, 54292
        • Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie
      • Wedel, Germany, 22880
        • Urologische Praxis
      • Westerstede, Germany, 26655
        • Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede Aurich Rhauder

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients ineligible for palliative cisplatin-based chemotherapy or who received prior adjuvant/ neoadjuvant chemotherapy or chemo radiation with a treatment-free interval more than 12 months (1L)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival Rate (OS rate)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Median Overall Survival (OS)
Time Frame: Initiation of study treatment until death or end of study, approximately 4 years
Initiation of study treatment until death or end of study, approximately 4 years
Median Progression Free Survival (PFS)
Time Frame: Initiation of study treatment to first measured disease progression, through end of study (approximately 4 years)
Initiation of study treatment to first measured disease progression, through end of study (approximately 4 years)
Percentage of participants with adverse events
Time Frame: Up to approximately 4 years
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2017

Primary Completion (Actual)

August 28, 2018

Study Completion (Actual)

January 28, 2019

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

January 8, 2018

First Posted (Actual)

January 16, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML39704

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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