Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection

Amgen

Status: Completed

Conditions: Melanoma; Herpetic Infection

Study type: Observational

Funder types: Industry

Identifiers

NCT02910557

20130193

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has provided written informed consent
• Patient is an adult (≥ 18 years of age at the time of informed consent) with a diagnosis of melanoma
• Patient enrolled within 1 month of receiving the first dose of IMLYGIC for the treatment of melanoma

Exclusion criteria

- Patient has a prior history of being a subject in an interventional clinical trial for IMLYGIC