A Non-interventional Real-World Study on Dose Modifications of Enfortumab Vedotin (EV) in Combination with Pembrolizumab (P) in Previously Untreated Patients with Advanced Urothelial Carcinoma in Germany

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000467
• EU PAS number:
  EUPAS1000000467
• Study ID:
  1000000467
• Official title and acronym:
  A Non-interventional Real-World Study on Dose Modifications of Enfortumab Vedotin (EV) in Combination with Pembrolizumab (P) in Previously Untreated Patients with Advanced Urothelial Carcinoma in Germany
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This is a real-world study; it is about collecting information only. The individual’s doctor decides on treatment, not the sponsor (Astellas). Information about how people with advanced urothelial cancer are treated with enfortumab vedotin and pembrolizumab in clinics in Germany will be collected.
• Study status:
  Planned

Research institutions and networks

Institutions

Astellas Pharma Europe Ltd.

Study timelines

Date when funding contract was signed

Planned: 10/09/2024

Study start date

Planned: 17/02/2025

Data analysis start date

Planned: 25/11/2027

Date of interim report, if expected

Planned: 26/11/2026

Date of final study report

Planned: 28/03/2028

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-3558