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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall Survival Rate (OS rate)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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