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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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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab is administered via IV 1200 mg every 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rate (OS rate) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis Dr.med. Wolfgang Hölzer | Berlin | 13055 | Germany | |||
| Urologie Schlosscarree |
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| Percentage of participants with adverse events | Up to approximately 4 years |
| 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 | 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 | Saarbrücken | 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 |
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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