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)
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)
6. Study drug(s) information
Product NameBAVENCIO®
CountryGermany
Substance INN(s)Avelumab
7. Medical conditions to be studied
Medical condition(s)Yes
Urothelial cancer of renal pelvis
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects580
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Prospective patient-based data collection
11. Scope of the study
What is the scope of the study?
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
This study will evaluate effectiveness and safety of Avelumab (according to local label) as maintenance therapy administered after completion of first line platinum-based chemotherapy in patients with locally advanced or metastatic urothelial cancer (who have not progressed with first-line platinum-based chemotherapy) under routine conditions in Germany, Russia, Spain and Switzerland.
Are there primary outcomes?Yes
To evaluate overall survival (OS) rate at 12, 24, and 36 months after the index date (baseline visit) in patients receiving Avelumab maintenance therapy
Are there secondary outcomes?Yes
To assess OS and health-related quality of life (HRQoL) in patients receiving Avelumab maintenance therapy
To evaluate anti-tumor effectiveness and safety and tolerability of Avelumab maintenance therapy
To assess progression-free survival (PFS) on Avelumab maintenance therapy and progression-free survival 2 (PFS2) on Avelumab maintenance therapy followed by second-line treatment
13. Study design
What is the design of the study?
international, multi-center, prospective, single-arm, observational real-world/non-interventional study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
36 months
15. Data analysis plan
Please provide a brief summary of the analysis method
Descriptive analyses will be performed to gain an understanding of the qualitative and quantitative nature of the data collected and the characteristics of the sample studied. Continuous variables will be described with the following measures of central tendency and dispersion: the number of patients, missing observations, mean, standard deviation, median, interquartile range, minimum, and maximum. Frequency, percentage, and number of missing observations will be provided for categorical variables. Exact Clopper-Pearson 95% CIs will be included where appropriate. The Kaplan-Meier method will be used for the analysis of time to event objectives. In general, descriptive statistics of quantitative parameters (results and change from baseline) will be provided for observed cases, that is, patients having non-missing assessments at a specific timepoint. Missing data count will be presented.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
