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.
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
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
- Conditions
- Urothelial Carcinoma
- 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.
Overall Survival Rate (OS rate)
Measured: 2 years
Secondary outcomes (3)
Median Overall Survival (OS)
Measured: Initiation of study treatment until death or end of study, approximately 4 years
Median Progression Free Survival (PFS)
Measured: Initiation of study treatment to first measured disease progression, through end of study (approximately 4 years)
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.
- First posted16 Jan 2018
- Study start28 Dec 2017
- Primary completion28 Aug 2018
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03399643
- Acronym / sponsor ID
- Announce / ML39704
- Conditions
- Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Tecentriq label restriction for first line limited the patient population and scientific question could not be answered in an appropriate time.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Have received prior immune checkpoint therapy
- Are pregnant or breastfeeding
- Are included in any other trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAtezolizumab is administered via IV 1200 mg every 3 weeks | Drug | – |
Primary outcome
Overall Survival Rate (OS rate)
Time frame: 2 years
3 secondary outcomes
Median Overall Survival (OS)
Time frame: 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)
Percentage of participants with adverse events
Time frame: Up to approximately 4 years
Results and safety
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.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
32 sites in 1 country: see every site and its status.
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?
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.