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

Terminated

• 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

Study Timeline

• Study First Submitted: 2017-12-19
• Study Start: 2017-12-28
• Study First Submitted QC: 2018-01-08
• Study First Posted: 2018-01-16
• Primary Completion: 2018-08-28
• Study Completion: 2019-01-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

• 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)

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

Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie; 🇩🇪 Halle (Saale), Germany

Urologische Praxis Michael Steinacker; 🇩🇪 Halle, Germany

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