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

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

Multiple centres: 52 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:01/01/2014

Study start date

Actual:26/04/2010

Data analysis start date

Planned:03/12/2021

Actual:03/11/2021

Date of final study report

Planned:22/04/2022

Actual:22/04/2022

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