Status: Ongoing First registered on: 23/08/2021
Last updated on: 09/09/2022
1. Study identification
EU PAS Register NumberEUPAS42413
Official titleAvelumab in real-world treatment of urothelial cancer – The AVENUE NIS
Study title acronymAVENUE
Study typeObservational study
Brief description of the studyThis study is a prospective, single-arm, observational real-world study in patients with locally advanced or metastatic urothelial cancer conducted in Germany, Spain, Russia and Switzerland. Patients whose disease did not progress on platinum-based first-line chemotherapy and who subsequently receive Avelumab (As per local label) as maintenance treatment in accordance with terms of marketing authorization will be enrolled. A total of approximately 580 eligible patients with locally advanced or metastatic urothelial cancer with any histology will be enrolled in this multi-center study. Patients will be recruited over a period of 36 months and followed up for 36 months from index date (defined as the date of start of Avelumab maintenance therapy in consented patients with locally advanced or metastatic urothelial cancer), irrespective of whether they continue or discontinue therapy. There will be a safety follow-up at 28 days post discontinuation.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameMerck Healthcare Germany GmbH
Centre locationMerck Healthcare Germany GmbH Waldstraße 3 64331 Weiterstadt
Details of (Primary) lead investigator
Title Dr
Last name Merck Healthcare Germany GmbHA, Darmstadt, Germany
First name Communication Center
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?81
Countries in which this study is being conducted
International study

Germany
Russian Federation
Spain
Switzerland
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed21/01/202121/01/2021
Start date of data collection04/09/202124/09/2021
Start date of data analysis
Date of interim report, if expected
Date of final study report30/04/2028
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesARES Trading S.A. Zone Industrielle de l’Ouriettaz, CH-1170 Aubonne, Switzerland100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Gschwend
First name Jürgen E.
Address line 1Department of Urology, Technical University of Munich, Rechts der Isar Medical Center
Address line 2Ismaninger-Strasse 22 
Address line 3 
CityMunich 
Postcode81675 
CountryGermany
Phone number (incl. country code)498941402522 
Alternative phone number498941402521 
Fax number (incl. country code) 
Email address mriu@mri.tum.de
Public Enquiries
Title Dr 
Last name Gschwend 
First name Jürgen E. 
Address line 1Department of Urology, Technical University of Munich, Rechts der Isar Medical Center 
Address line 2Ismaninger-Strasse 22 
Address line 3 
CityMunich 
Postcode81675 
CountryGermany 
Phone number (incl. country code)498941402522 
Alternative phone number498941402521 
Fax number (incl. country code) 
Email address mriu@mri.tum.de 
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