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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational registry

Study drug and medical condition

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

  talimogene laherparepvec

Population studied

• Short description of the study population:
  Investigators will be expected to maintain a screening log of all potential study candidates, including the date of screening and the outcome of the screening process (eg, enrolled into study, reason for ineligibility). Before any study activities begin, including data collection, the appropriate written informed consent/assent must be obtained.; ; Inclusion Criteria; - All subjects must provide informed consent prior to initiation of any study activities. When the subject is legally too young to provide informed consent/assent, subject’s legally acceptable representative must provide informed consent/assent based on local regulations and/or guidelines prior to initiation of any study activities; - All subjects must have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type and must have discontinued treatment and participation, including long-term follow-up (if applicable) in that trial; ; Exclusion Criteria; - Subjects currently receiving talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial; - Subject currently participating, including for long-term follow-up (if applicable), in other Amgen-sponsored talimogene laherparepvec clinical trial.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  186

Study design details

• Main study objective:
  The main objectives of this study are to: evaluate the long-term safety of talimogene laherparepvec, monitor subject overall survival monitor use of subsequent anti-cancer therapy, for the tumor indication in the prior Amgen or BioVEX-sponsored clinical trial, including retreatment with marketed talimogene laherparepvec in subjects previously enrolled in Amgen or BioVEX-sponsored trials.
• Outcomes:
  • subject incidence of all talimogene laherparepvec treatment-related adverse events (AEs) of any grade, grade ≥ 3 AEs, serious and fatal AEs, and AEs of interest that begin after the defined reporting period has ended on the previous Amgen or BioVEX-sponsored talimogene laherparepvec clinical trial ; • survival status ; • use of subsequent anti-cancer therapy for specific tumor type.
• Data analysis plan:
  The statistical reporting of the safety endpoints and overall survival will be entirely descriptive, with no formal statistical testing performed. Descriptive analyses and listings for the safety endpoints are planned. Categorical outcomes will be described using the frequency and percent. Continuous outcomes will be described using the mean, median, standard deviation, minimum, and maximum. AEs will be coded with the most recent version of Medical Dictionary for Regulatory Activities and will be grouped by system organ class and preferred term (PT) within system organ class. Event severity will be graded using CTCAE version 4.0.