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

NCT03399643 | Terminated FDA Drug

• 1 other identifier: ML39704
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 32

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

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival Rate (OS rate)

  2 years

Secondary Outcomes (3)

• Median Overall Survival (OS)

  Initiation of study treatment until death or end of study, approximately 4 years

• Median Progression Free Survival (PFS)

  Initiation of study treatment to first measured disease progression, through end of study (approximately 4 years)

• Percentage of participants with adverse events

  Up to approximately 4 years

Interventions

Atezolizumab DRUG

Atezolizumab is administered via IV 1200 mg every 3 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• Have received prior immune checkpoint therapy
• Are pregnant or breastfeeding
• Are included in any other trial

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (32)

Praxis Dr.med. Wolfgang Hölzer

Berlin, 13055, Germany

Location

Urologie Schlosscarree

Braunschweig, 38100, Germany

Location

Urologische Praxis Dr. Krieger

Chemnitz, 09127, Germany

Location

Zeisigwaldkliniken Bethanien

Chemnitz, 09130, Germany

Location

St. Georg Klinikum Eisenach GmbH

Eisenach, 99817, Germany

Location

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

Flensburg, 24939, Germany

Location

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

Frankfurt am Main, 65929, Germany

Location

Dres.Jochen Wilke und Harald Wagner

Fürth, 90766, Germany

Location

Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

Halle, 06120, Germany

Location

Urologische Praxis Michael Steinacker

Halle, 06120, Germany

Location

Asklepios Klinik Altona, Abteilung für Urologie

Hamburg, 22763, Germany

Location

Onkologische Praxis in Heidenheim

Heidenheim, 89522, Germany

Location

St. Bernward-Krankenhaus

Hildesheim, 31134, Germany

Location

Onkologische Praxis Landshut

Landshut, 84036, Germany

Location

Gemeinschaftspraxis; Onkologisches Zentrum Lebach; Caritas Krankenhaus Lebach

Lebach, 66822, Germany

Location

ÜBAG MVZ Mitte / MVZ Delitzsch GmbH, Standort Leipzig

Leipzig, 04103, Germany

Location

Sankt Elisabeth Krankenhaus; Urlogische Abt.

Leipzig, 04277, Germany

Location

Drk Krankenhaus Luckenwalde

Luckenwalde, 14943, Germany

Location

Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Urologie

Lübeck, 23538, Germany

Location

Urologikum Lübeck

Lübeck, 23566, Germany

Location

Urologischen Praxis in Lüneburg

Lüneburg, 21335, Germany

Location

Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie

Mannheim, 68167, Germany

Location

Praxis Markkleeberg

Markkleeberg, 04416, Germany

Location

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

Minden, 32429, Germany

Location

Städt.Kliniken München GmbH Klinikum Bogenhausen

München, 81925, Germany

Location

Praxis Dr. Uhlig, Naunhof

Naunhof, 04683, Germany

Location

Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie/Onkologie

Paderborn, 33098, Germany

Location

Praxis für Hämatologie & Onkologie

Saarbrücken, 66113, Germany

Location

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

Stade, 21680, Germany

Location

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

Trier, 54292, Germany

Location

Urologische Praxis

Wedel, 22880, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede Aurich Rhauder

Westerstede, 26655, Germany

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 16, 2018
• Study Start: December 28, 2017
• Primary Completion: August 28, 2018
• Study Completion: January 28, 2019
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

DE (32)