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

Study Overview
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Brief Summary
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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.

Official Title
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A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC® in Clinical Practice to Characterize Risk of Herpetic Infection Among Patients, Close Contacts, Health Care Providers & Long-term Safety in Treated Patients

Conditions
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Melanoma, Herpetic Infection

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate | Estimate the incidence rate of herpetic infection with detection of talimogene laherparepvec (T-VEC) DNA among patients for up to 5 years after the first IMLYGIC dose. | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Herpectic Infection with T-VEC DNA for Close Contacts and Healthcare Providers (HCPs) | Count the number of herpetic infections with detection of T-VEC DNA among close contacts and HCPs. | Through study completion, average of 5 years | 
| Incidence of Herpetic Infection with T-VEC in Patients During Treatment | Estimate the incidence rate of herpetic infection with detection of T-VEC DNA among patients during treatment with IMLYGIC. | Through treatment period, up to 1 year | 
| Incidence of Herpetic Infection with T-VEC in Patients After Treatment | Estimate the incidence rate of herpetic infection with detection of T-VEC DNA among patients after discontinuation of IMLYGIC. | Through study completion, average of 5 years | 
| Incidence of Herpes Simplex Virus 1 (HSV-1) DNA in Patients During Treatment | Estimate the incidence rate of herpetic infection with detection of wild-type HSV-1 DNA among patients during treatment with IMLYGIC. | Through treatment period, up to 1 year | 
| Incidence of HSV-1 DNA in Patients After Treatment | Estimate the incidence rate of herpetic infection with detection of wild-type HSV-1 DNA among patients after discontinuation of IMLYGIC. | Through study completion, average of 5 years | 
| Patient Demographics | The following baseline variables will be recorded: sex, age, Eastern Cooperative Oncology Group (ECOG) performance status. | Through study completion, average of 5 years | 
| Use of Drug Therapies | Describe the use of IMLYGIC, other anti-cancer therapy, anti-herpetic therapy. | Through study completion, average of 5 years | 
| Incidence of Adverse Events and Serious Adverse Events in Patients | Incidence of adverse events and serious adverse events during and after treatment with IMLYGIC | Through study completion, average of 5 years | 
| Overall Survival | Survival is defined by the time to death from the date of the first use of IMLYGIC. | Through study completion, average of 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IMLYGIC, Talimogene Laherparepvec, Herpetic, Infection Melanoma