A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC® (Talimogene Laherparepvec) in Clinical Practice to Characterize the Risk of Herpetic Infection Among Patients, Close Contacts, and Health Care Providers (20130193)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20631
• EU PAS number:
  EUPAS15128
• Study ID:
  20631
• Official title and acronym:
  A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC® (Talimogene Laherparepvec) in Clinical Practice to Characterize the Risk of Herpetic Infection Among Patients, Close Contacts, and Health Care Providers (20130193)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Finland

  Norway

  Sweden

  United States
• Study description:
  Cohort study of melanoma patients for up to 5 years after the first IMLYGIC dose.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 35 involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/05/2016

Actual: 01/05/2016

Study start date

Planned: 14/08/2017

Actual: 10/08/2017

Data analysis start date

Planned: 06/08/2038

Date of final study report

Planned: 06/08/2038

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.

Study protocol

Initial protocol

Protocol-Published Original talimogene laherparepvec 20130193 .pdf

Updated protocol

Protocol-Published Superseding talimogene laherparepvec 20130193 5 .pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)