Avelumab in real-world treatment of urothelial cancer – The AVENUE NIS

Study identification

• EU PAS number:
  EUPAS42413
• Study ID:
  48917
• Official title and acronym:
  Avelumab in real-world treatment of urothelial cancer – The AVENUE NIS
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Russian Federation

  Spain

  Switzerland
• Study description:
  This 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 350 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 first administration date, after AVENUE NIS informed consent signature, of Avelumab maintenance therapy to 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Merck Healthcare KGaA

Germany

Study timelines

Date when funding contract was signed

Planned:21/01/2021

Actual:21/01/2021

Study start date

Planned:04/09/2021

Actual:24/09/2021

Date of final study report

Planned:30/04/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ARES Trading S.A. Zone Industrielle de l’Ouriettaz, CH-1170 Aubonne, Switzerland

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable