Study identification

EU PAS number

EUPAS43115

Study ID

47499

Official title and acronym

A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials

DARWIN EU® study

No

Study countries

Austria
Canada
France
Germany
Greece
Hungary
Italy
Korea, Republic of
Poland
Russian Federation
South Africa
Spain
Switzerland
United Kingdom
United States

Study description

This is an international, multicenter, strictly observational registry program for subjects who have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type and have ended treatment and participation, including long-term follow-up, in that trial. No experimental intervention is involved. The study will evaluate the overall survival, use of subsequent anti-cancer therapy, and the long-term safety of subjects. The duration of the study will vary for each subject. Each subject will participate in this study until withdrawal of consent, death, or end of study, whichever occurs first. The registry study will end when the sponsor (in consultation with the regulatory authorities) has determined that the collection of long-term safety and survival data are no longer necessary.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution
Multiple centres: 52 centres are involved in the study

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

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

Amgen
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 2 (specific obligation of marketing authorisation)

Regulatory procedure number

2015-003196-29