Clinical Characteristics of The First IMLYGIC™ Patients With Unresectable Stage IIIB-IVM1a Melanoma Treated in Routine Clinical Practice, in Selected European Countries (20140413)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective observational chart review study

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 stage III

  Malignant melanoma stage IV

Population studied

• Short description of the study population:
  Unresectable stage IIIB-IVM1a melanoma patients who received at least an initial IMLYGIC® dose at a concentration of 106 plaque forming units (PFU)/mL and at least one subsequent dose at a concentration of 108 PFU/Ml as per the EU marketing authorisation during the study eligibility period, was 18 years of age or older at the time of first IMLYGIC® administration, and patient/legal representative provided informed consent, where required.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Melanoma patients
• Estimated number of subjects:
  60

Study design details

• Main study objective:
  To characterise patients with melanoma at time of first IMLYGIC™ administration in terms of demographics, disease history, and clinical and tumour characteristics
• Outcomes:
  Characterise patients with melanoma at time of first IMLYGIC™ administration in terms of demographics disease history and clinical and tumour characteristics, • Use of IMLYGIC • Use of other melanoma treatment• Clinical outcomes and events of interest • Describe physician’s decision making process and rationale for prescribing
• Data analysis plan:
  Analysis will be descriptive with appropriate statistical methods (ie, mean, standard deviation, median, quartiles, minimum and maximum for continuous variables, numbers and percentages for categorical variables).

Documents

Study results

20140413 Observational Research Study Report Abstract