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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  IMLYGIC
• Study drug International non-proprietary name (INN) or common name:
  TALIMOGENE LAHERPAREPVEC
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XX51) talimogene laherparepvec

  talimogene laherparepvec
• Medical condition to be studied:
  Malignant melanoma
• Additional medical condition(s):
  Herpetic Infection

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  300

Study design details

• Study design:
  This postmarketing prospective cohort study will follow melanoma patients for up to 5 years after the first IMLYGIC dose in clinical practice. There is no experimental intervention, and the study population will receive standard-of-care treatment as determined by their treating physician.
• Main study objective:
  The primary objective is to estimate the incidence rate of herpetic infection with detection of talimogene laherparepvec DNA among patients for up to 5 years after the first IMLYGIC dose.
• Outcomes:
  Incidence of herpetic infection with detection of talimogene laherparepvec DNA among patients, - Count of herpetic infections with detection of talimogene laherparepvec DNA among close contacts and HCPs- Summary of patient characteristics- Treatment patterns of anticancer therapy (eg, types and sequence)- Incidence of use of anti-herpetic therapy- Incidence of adverse events and serious adverse events during treatment with IMLYGIC- Overall survival
• Data analysis plan:
  The statistical analysis will be entirely descriptive and no formal hypothesis will be tested.