Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection
Study Details
A postmarketing Cohort study of Melanoma patients treated with IMLYGIC (Talimogene Laherparepvec) in clinical Practice to Characterize the risk of herpetic infection with detection of Talimogene Laherparepvec DNA among patients, close contacts, and health care providers; and long term safety in treated patients for up to 5 years after the first IMLYGIC dose.
Protocol Summary
Incidence Rate
Timeframe: Up to 5 years
Herpectic Infection with T-VEC DNA for Close Contacts and Healthcare Providers (HCPs)
Timeframe: Through study completion, average of 5 years
Incidence of Herpetic Infection with T-VEC in Patients During Treatment
Timeframe: Through treatment period, up to 1 year
Incidence of Herpetic Infection with T-VEC in Patients After Treatment
Timeframe: Through study completion, average of 5 years
Incidence of Herpes Simplex Virus 1 (HSV-1) DNA in Patients During Treatment
Timeframe: Through treatment period, up to 1 year
Incidence of HSV-1 DNA in Patients After Treatment
Timeframe: Through study completion, average of 5 years
Patient Demographics
Timeframe: Through study completion, average of 5 years
Use of Drug Therapies
Timeframe: Through study completion, average of 5 years
Incidence of Adverse Events and Serious Adverse Events in Patients
Timeframe: Through study completion, average of 5 years
Overall Survival
Timeframe: Through study completion, average of 5 years