Study identification

EU PAS number

EUPAS1000000763

Study ID

1000000763

Official title and acronym

Real-life Enfortumab Vedotin Outcomes as First-line Urothelial Carcinoma Treatment in the Non-interventional Observational and Nationwide French Study

DARWIN EU® study

No

Study countries

France

Study description

In France, an early access program gave people with unresectable or metastatic urothelial cancer access to enfortumab vedotin and pembrolizumab before their use together was approved by the health authority. This study will use the information from this early access program. It will also use information from medical charts in medical centers and health insurance records in France to learn more about people with unresectable or metastatic urothelial cancer who use enfortumab vedotin and pembrolizumab. This study is about collecting information only. The individual’s doctor decides on treatment, not the sponsor (Astellas). Researchers will learn about the use of enfortumab vedotin together with pembrolizumab in standard clinical practice in France between January 2020 and December 2027.

Study status

Planned
Research institutions and networks

Institutions

Astellas Pharma Europe Ltd.
IQVIA UK

Networks

N/A

Contact details

Matthiew Trancart

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
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