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

Launched by AMGEN · Sep 20, 2016

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a treatment called IMLYGIC (Talimogene Laherparepvec) in patients with melanoma, which is a type of skin cancer. The main focus is to understand the risk of herpetic infection, which is caused by the herpes virus, in patients who receive this treatment. Researchers will also look for the presence of IMLYGIC DNA in patients, their close contacts, and healthcare providers to see how the treatment affects them. The study will follow participants for up to five years after they receive their first dose of IMLYGIC.

To be eligible for this trial, you must be at least 18 years old, have been diagnosed with melanoma, and provide written consent to participate. You should also be enrolled within one month of receiving your first dose of IMLYGIC. If you have previously participated in a different IMLYGIC trial, you won't be able to join this one. Participants can expect regular check-ups and monitoring throughout the study to ensure their safety and gather important information about the treatment's effects.

Gender

ALL

Eligibility criteria

• 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