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NCT03399643 Clinical Trial

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

Urothelial Carcinoma Clinical Trial

— Announce  

Official title:
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)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03399643
Other study ID # ML39704
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 28, 2017
Est. completion date January 28, 2019

Study information
Verified date April 2019
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 22
Est. completion date January 28, 2019
Est. primary completion date August 28, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Atezolizumab
Atezolizumab is administered via IV 1200 mg every 3 weeks

Locations
Country Name City State
Germany Praxis Dr.med. Wolfgang Hölzer Berlin
Germany Urologie Schlosscarree Braunschweig
Germany Urologische Praxis Dr. Krieger Chemnitz
Germany Zeisigwaldkliniken Bethanien Chemnitz
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 Urologische Praxis Michael Steinacker Halle
Germany Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie Halle (Saale)
Germany Asklepios Klinik Altona, Abteilung für Urologie Hamburg
Germany Onkologische Praxis in Heidenheim Heidenheim
Germany St. Bernward-Krankenhaus Hildesheim
Germany Onkologische Praxis Landshut Landshut
Germany Gemeinschaftspraxis; Onkologisches Zentrum Lebach; Caritas Krankenhaus Lebach Lebach
Germany Sankt Elisabeth Krankenhaus; Urlogische Abt. Leipzig
Germany ÜBAG MVZ Mitte / MVZ Delitzsch GmbH, Standort Leipzig Leipzig
Germany Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Urologie Lübeck
Germany Urologikum Lübeck Lübeck
Germany Drk Krankenhaus Luckenwalde Luckenwalde
Germany Urologischen Praxis in Lüneburg Lüneburg
Germany Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie Mannheim
Germany Praxis Markkleeberg Markkleeberg
Germany Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Hämatologie, Onkologie und Pallia. Minden
Germany Städt.Kliniken München GmbH Klinikum Bogenhausen München
Germany Praxis Dr. Uhlig, Naunhof Naunhof
Germany Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie/Onkologie Paderborn
Germany Praxis für Hämatologie & Onkologie Saarbruecken
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

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Survival Rate (OS rate) 2 years
Secondary Median Overall Survival (OS) Initiation of study treatment until death or end of study, approximately 4 years
Secondary Median Progression Free Survival (PFS) Initiation of study treatment to first measured disease progression, through end of study (approximately 4 years)
Secondary Percentage of participants with adverse events Up to approximately 4 years
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