A Study to Investigate The Effectiveness Of Atezolizumab In Patients With Inoperable Locally-Advanced Or Metastatic Urothelial Carcinoma Of The Urinary Tract (Announce)
- Conditions
- Urothelial Carcinoma
- Registration Number
- NCT03399643
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 22
- 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
- Have received prior immune checkpoint therapy
- Are pregnant or breastfeeding
- Are included in any other trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival Rate (OS rate) 2 years
- Secondary Outcome Measures
Name Time Method Median Overall Survival (OS) Initiation of study treatment until death or end of study, approximately 4 years Percentage of participants with adverse events Up to approximately 4 years Median Progression Free Survival (PFS) Initiation of study treatment to first measured disease progression, through end of study (approximately 4 years)
Trial Locations
- Locations (32)
Urologische Praxis Dr. Krieger
🇩🇪Chemnitz, Germany
Praxis Dr.med. Wolfgang Hölzer
🇩🇪Berlin, Germany
Zeisigwaldkliniken Bethanien
🇩🇪Chemnitz, Germany
Urologie Schlosscarree
🇩🇪Braunschweig, Germany
St. Georg Klinikum Eisenach GmbH
🇩🇪Eisenach, Germany
St. Franziskus-Hospital; Malteser Krankenhaus; Medizinische Klinik I
🇩🇪Flensburg, Germany
Klinikum Frankfurt Höchst GmbH; Klinik Innere Medizin 3 - Hämatologie, Onkologie, Palliativmedizin
🇩🇪Frankfurt am Main, Germany
Dres.Jochen Wilke und Harald Wagner
🇩🇪Fürth, Germany
Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
🇩🇪Halle (Saale), Germany
St. Bernward-Krankenhaus
🇩🇪Hildesheim, Germany
Urologische Praxis Michael Steinacker
🇩🇪Halle, Germany
Asklepios Klinik Altona, Abteilung für Urologie
🇩🇪Hamburg, Germany
Onkologische Praxis in Heidenheim
🇩🇪Heidenheim, Germany
Onkologische Praxis Landshut
🇩🇪Landshut, Germany
ÜBAG MVZ Mitte / MVZ Delitzsch GmbH, Standort Leipzig
🇩🇪Leipzig, Germany
Gemeinschaftspraxis; Onkologisches Zentrum Lebach; Caritas Krankenhaus Lebach
🇩🇪Lebach, Germany
Sankt Elisabeth Krankenhaus; Urlogische Abt.
🇩🇪Leipzig, Germany
Drk Krankenhaus Luckenwalde
🇩🇪Luckenwalde, Germany
Urologikum Lübeck
🇩🇪Lübeck, Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Urologie
🇩🇪Lübeck, Germany
Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie
🇩🇪Mannheim, Germany
Urologischen Praxis in Lüneburg
🇩🇪Lüneburg, Germany
Städt.Kliniken München GmbH Klinikum Bogenhausen
🇩🇪München, Germany
Praxis Markkleeberg
🇩🇪Markkleeberg, Germany
Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Hämatologie, Onkologie und Pallia.
🇩🇪Minden, Germany
Praxis Dr. Uhlig, Naunhof
🇩🇪Naunhof, Germany
Praxis für Hämatologie & Onkologie
🇩🇪Saarbruecken, Germany
Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie/Onkologie
🇩🇪Paderborn, Germany
MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
🇩🇪Stade, Germany
Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie
🇩🇪Trier, Germany
Urologische Praxis
🇩🇪Wedel, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede Aurich Rhauder
🇩🇪Westerstede, Germany