A postmarketing cohort study of melanoma patients treated with IMLYGIC (talimogene laherparepvec) in clinical practice to characterize the risk of herpes infection with detection of talimogene laherparepvec DNA in patients, close contacts and healthcare providers, and long-term safety in treated patients up to 5 years after the first IMLYGIC dose.
Aim of the study
The aim of this study is to gain further insight into whether patients treated with IMLYGIC can become infected with herpes simplex virus type 1 through the drug and pass the infection on to close contacts (people living in the same household, caregivers, sexual partners or other people with whom the bed is shared) or to medical staff.
Who can take part?
Patients with melanoma / herpes infection with detection of Talimogene Laherparepvec DNA
Procedure
At the beginning of the study, you will be asked to answer questions about your medical history, including previous herpes infections and medications. This information about your health will then be collected at your doctor's appointments approximately every 2 weeks during your treatment with IMLYGIC and again approximately every 3 months after your treatment has ended.your study doctor or study staff will inform you about the signs and symptoms of a herpes infection, including what a so-called herpetic lesion looks like. You are advised to consult a doctor as soon as possible if you suspect that you have developed a herpetic lesion. Your doctor will examine the lesion and possibly test whether it was caused by the normal herpes simplex virus type 1 or by IMLYGIC. Your consent is a prerequisite for carrying out this test.
Compensation
None
Original study name
A prospective post-marketing cohort study of melanoma patients treated with IMLYGIC® in clinical practice to characterize the risk of herpes infections in patients, close contacts and healthcare providers and long-term safety in treated patients
BASEC number
2018-00720
Financial support from
Amgen