Study identification

EU PAS number

EUPAS105591

Study ID

105592

Official title and acronym

Real-world use of enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer previously treated with chemotherapy and immunotherapy: a multicenter, retrospective, non-interventional study in France

DARWIN EU® study

No

Study countries

France

Study description

In France, there was an early access program for people with severe diseases who do not have any other available treatment options. In an early access program, people access new medicines before they are approved by Health Authorities. Enfortumab vedotin is a treatment for cancer in the bladder lining (urothelial cancer). It was available for use in the early access program in France for adults with locally advanced or metastatic urothelial cancer. Locally advanced means the cancer had spread to tissue close by. Metastatic means the cancer has spread to other parts of the body. People in the program had been previously treated with all available standard therapies. In the program they were treated with enfortumab vedotin according to their clinic’s standard practice. This is also known as real-world use. This study is about collecting information about adults with locally advanced or metastatic urothelial cancer from the early access program. They will have received at least 1 treatment with enfortumab vedotin between 08 Jul 2022 and 31 Dec 2022. The main aim of the study is to learn if enfortumab vedotin extended the lives of people taking part in the program. This aim is also called overall survival, or OS. Information will be collected from the medical charts, beginning just before each person started treatment with enfortumab vedotin (also known as the baseline). This will continue with documented information for up to 12 months of treatment, or if the person died or could not be contacted within the 12 months of treatment.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 50

Contact details

Kahina Makhloufi

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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