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.