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Urothelial CarcinomaAnnounceNCT03399643

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

An observational study of Urothelial Carcinoma, run by Hoffmann-La Roche at 32 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
How many people
22 participants
Where
32 sitesGermany
Study dates
28 Dec 2017to 28 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

Germany32 sites

  • Praxis Dr.med. Wolfgang Hölzer

    Berlin, 13055

  • Urologie Schlosscarree

    Braunschweig, 38100

  • Urologische Praxis Dr. Krieger

    Chemnitz, 09127

  • Zeisigwaldkliniken Bethanien

    Chemnitz, 09130

  • St. Georg Klinikum Eisenach GmbH

    Eisenach, 99817

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

    Flensburg, 24939

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

    Frankfurt am Main, 65929

  • Dres.Jochen Wilke und Harald Wagner

    Fürth, 90766

  • Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

    Halle, 06120

  • Urologische Praxis Michael Steinacker

    Halle, 06120

  • Asklepios Klinik Altona, Abteilung für Urologie

    Hamburg, 22763

  • Onkologische Praxis in Heidenheim

    Heidenheim, 89522

  • St. Bernward-Krankenhaus

    Hildesheim, 31134

  • Onkologische Praxis Landshut

    Landshut, 84036

  • Gemeinschaftspraxis; Onkologisches Zentrum Lebach; Caritas Krankenhaus Lebach

    Lebach, 66822

  • ÜBAG MVZ Mitte / MVZ Delitzsch GmbH, Standort Leipzig

    Leipzig, 04103

  • Sankt Elisabeth Krankenhaus; Urlogische Abt.

    Leipzig, 04277

  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Urologie

    Lübeck, 23538

  • Urologikum Lübeck

    Lübeck, 23566

  • Drk Krankenhaus Luckenwalde

    Luckenwalde, 14943

  • Urologischen Praxis in Lüneburg

    Lüneburg, 21335

  • Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie

    Mannheim, 68167

  • Praxis Markkleeberg

    Markkleeberg, 04416

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

    Minden, 32429

  • Städt.Kliniken München GmbH Klinikum Bogenhausen

    München, 81925

  • Praxis Dr. Uhlig, Naunhof

    Naunhof, 04683

  • Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie/Onkologie

    Paderborn, 33098

  • Praxis für Hämatologie & Onkologie

    Saarbrücken, 66113

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

    Stade, 21680

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

    Trier, 54292

  • Urologische Praxis

    Wedel, 22880

  • Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede Aurich Rhauder

    Westerstede, 26655

Other trials in Germany

About this study

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)

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

Being tested
Atezolizumab
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Atezolizumab is administered via IV 1200 mg every 3 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival Rate (OS rate)

    Measured: 2 years

Secondary outcomes (3)

  1. Median Overall Survival (OS)

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

  2. Median Progression Free Survival (PFS)

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

  3. Percentage of participants with adverse events

    Measured: Up to approximately 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2018
  2. Study start28 Dec 2017
  3. Primary completion28 Aug 2018
  4. Study completion28 Jan 2019

Why it stopped: Tecentriq label restriction for first line limited the patient population and scientific question could not be answered in an appropriate time.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03399643
Sponsor's protocol ID
ML39704
Acronym
Announce
Status last verified
Apr 2019
First submitted
19 Dec 2017
Last updated
19 Apr 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Urothelial Carcinoma, run by Hoffmann-La Roche at 32 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Tecentriq label restriction for first line limited the patient population and scientific question could not be answered in an appropriate time.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival Rate (OS rate) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03399643.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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