Enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer previously treated with chemotherapy and immunotherapy: a multicenter, non-interventional study in Italy (EVIDENCE)

Study identification

• EU PAS number:
  EUPAS107848
• Study ID:
  199003
• Official title and acronym:
  Enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer previously treated with chemotherapy and immunotherapy: a multicenter, non-interventional study in Italy (EVIDENCE)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  The purpose of this study is to describe the safety and tolerability of enfortumab vedotin (EV), in a real-world setting, in patients treated according to the EMA/AIFA (Italian Medicines Agency) approved indication. This study will also describe how EV drug-related adverse events impacted course of treatment, characteristics of patients treated with EV in real-world clinical practice, describe real-world treatment patterns of EV and describe real-world effectiveness of EV.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Multiple centres: 15 centres involved in the study

Study timelines

Date when funding contract was signed

Planned: 13/12/2023

Actual: 29/11/2023

Study start date

Planned: 01/04/2024

Actual: 29/05/2024

Data analysis start date

Planned: 01/07/2026

Date of interim report, if expected

Planned: 01/07/2025

Date of final study report

Planned: 01/01/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Europe Ltd.

Regulatory

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

Other study registration identification numbers and links

7465-MA-3500