ClinicalTrials.gg
TerminatedNCT03399643AnnounceUpdated Apr 19, 2019

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 in Urothelial Carcinoma, sponsored by Hoffmann-La Roche. Terminated at 32 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-19.

Sponsored by Hoffmann-La Roche · Observational

Why this study was terminated
Tecentriq label restriction for first line limited the patient population and scientific question could not be answered in an appropriate time.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
22
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 12 studies in Carcinoma, Transitional Cell by Hoffmann-La Roche — none open to participants now, 1 under way, none of them phase 3. Carcinoma, Transitional Cell · Hoffmann-La Roche.

Started
2017
with 2 others
Observational
4 of 12
none open now
Registered
7th of 12
by date

Among the 12 studies in Carcinoma, Transitional Cell by Hoffmann-La Roche, this one is one of 3 that started in 2017, is one of 4 observational ones, and was the 7th registered.

Carcinoma, Transitional Cell

633 studies on the registry are indexed under Carcinoma, Transitional Cell; 180 are open to participants now.

Browse Carcinoma, Transitional Cell studies →

Open to participants now

None of the 12 studies in Carcinoma, Transitional Cell by Hoffmann-La Roche is open now. The open studies under Carcinoma, Transitional Cell, anywhere →

Who these studies take

Of the 147 Carcinoma, Transitional Cell studies recruiting now, 121 (82%) set no upper age limit and 11 (7%) stop at 75 or younger; 4 take children under 18; 8 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 12 studies in Carcinoma, Transitional Cell by Hoffmann-La Roche as a file.
02

Study 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

03

Conditions studied

  • Urothelial Carcinoma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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)

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Inclusion criteria

  • 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

Exclusion Criteria:

  • Have received prior immune checkpoint therapy
  • Are pregnant or breastfeeding
  • Are included in any other trial
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
22 participants (actual)
Patient registry
No

Interventions

  • Atezolizumab is administered via IV 1200 mg every 3 weeks

06

What researchers measure

Primary outcomes

  1. Overall Survival Rate (OS rate)

    Time frame: 2 years

Secondary outcomes

  1. Median Overall Survival (OS)

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

  2. Median Progression Free Survival (PFS)

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

  3. Percentage of participants with adverse events

    Time frame: Up to approximately 4 years

07

Study locations

32 sites
  • Praxis Dr.med. Wolfgang Hölzer
    Berlin, 13055, Germany
  • Urologie Schlosscarree
    Braunschweig, 38100, Germany
  • Urologische Praxis Dr. Krieger
    Chemnitz, 09127, Germany
  • Zeisigwaldkliniken Bethanien
    Chemnitz, 09130, Germany
  • St. Georg Klinikum Eisenach GmbH
    Eisenach, 99817, Germany
  • St. Franziskus-Hospital; Malteser Krankenhaus; Medizinische Klinik I
    Flensburg, 24939, Germany
  • Klinikum Frankfurt Höchst GmbH; Klinik Innere Medizin 3 - Hämatologie, Onkologie, Palliativmedizin
    Frankfurt am Main, 65929, Germany
  • Dres.Jochen Wilke und Harald Wagner
    Fürth, 90766, Germany
  • Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
    Halle (Saale), 06120, Germany
  • Urologische Praxis Michael Steinacker
    Halle, 06120, Germany
  • Asklepios Klinik Altona, Abteilung für Urologie
    Hamburg, 22763, Germany
  • Onkologische Praxis in Heidenheim
    Heidenheim, 89522, Germany
  • St. Bernward-Krankenhaus
    Hildesheim, 31134, Germany
  • Onkologische Praxis Landshut
    Landshut, 84036, Germany
  • Gemeinschaftspraxis; Onkologisches Zentrum Lebach; Caritas Krankenhaus Lebach
    Lebach, 66822, Germany
  • ÜBAG MVZ Mitte / MVZ Delitzsch GmbH, Standort Leipzig
    Leipzig, 04103, Germany
  • Sankt Elisabeth Krankenhaus; Urlogische Abt.
    Leipzig, 04277, Germany
  • Drk Krankenhaus Luckenwalde
    Luckenwalde, 14943, Germany
  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Urologie
    Lübeck, 23538, Germany
  • Urologikum Lübeck
    Lübeck, 23566, Germany
  • Urologischen Praxis in Lüneburg
    Lüneburg, 21335, Germany
  • Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie
    Mannheim, 68167, Germany
  • Praxis Markkleeberg
    Markkleeberg, 04416, Germany
  • Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Hämatologie, Onkologie und Pallia.
    Minden, 32429, Germany
  • Städt.Kliniken München GmbH Klinikum Bogenhausen
    München, 81925, Germany
  • Praxis Dr. Uhlig, Naunhof
    Naunhof, 04683, Germany
  • Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie/Onkologie
    Paderborn, 33098, Germany
  • Praxis für Hämatologie & Onkologie
    Saarbruecken, 66113, Germany
  • MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
    Stade, 21680, Germany
  • Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie
    Trier, 54292, Germany
  • Urologische Praxis
    Wedel, 22880, Germany
  • Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede Aurich Rhauder
    Westerstede, 26655, Germany
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Aug 2018, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2017
First posted
Jan 16, 2018
StartActual
Dec 28, 2017
Primary completionActual
Aug 28, 2018
CompletionActual
Jan 28, 2019
Last update
Apr 19, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03399643
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jan 16, 2018
Start date
Dec 28, 2017
Primary completion
Aug 28, 2018
Completion
Jan 28, 2019
Last update
Apr 19, 2019

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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