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Completed

NCT Number: NCT02910557

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

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.

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Key information

Conditions

Melanoma Herpetic Infection Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universitaet Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence Rate

    Time frame: Up to 5 years

    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.

Secondary outcomes

  1. Herpectic Infection with T-VEC DNA for Close Contacts and Healthcare Providers (HCPs)

    Time frame: Through study completion, average of 5 years

    Count the number of herpetic infections with detection of T-VEC DNA among close contacts and HCPs.

  2. Incidence of Herpetic Infection with T-VEC in Patients During Treatment

    Time frame: Through treatment period, up to 1 year

    Estimate the incidence rate of herpetic infection with detection of T-VEC DNA among patients during treatment with IMLYGIC.

  3. Incidence of Herpetic Infection with T-VEC in Patients After Treatment

    Time frame: Through study completion, average of 5 years

    Estimate the incidence rate of herpetic infection with detection of T-VEC DNA among patients after discontinuation of IMLYGIC.

  4. Incidence of Herpes Simplex Virus 1 (HSV-1) DNA in Patients During Treatment

    Time frame: Through treatment period, up to 1 year

    Estimate the incidence rate of herpetic infection with detection of wild-type HSV-1 DNA among patients during treatment with IMLYGIC.

  5. Incidence of HSV-1 DNA in Patients After Treatment

    Time frame: Through study completion, average of 5 years

    Estimate the incidence rate of herpetic infection with detection of wild-type HSV-1 DNA among patients after discontinuation of IMLYGIC.

  6. Patient Demographics

    Time frame: Through study completion, average of 5 years

    The following baseline variables will be recorded: sex, age, Eastern Cooperative Oncology Group (ECOG) performance status.

  7. Use of Drug Therapies

    Time frame: Through study completion, average of 5 years

    Describe the use of IMLYGIC, other anti-cancer therapy, anti-herpetic therapy.

  8. Incidence of Adverse Events and Serious Adverse Events in Patients

    Time frame: Through study completion, average of 5 years

    Incidence of adverse events and serious adverse events during and after treatment with IMLYGIC

  9. Overall Survival

    Time frame: Through study completion, average of 5 years

    Survival is defined by the time to death from the date of the first use of IMLYGIC.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2016
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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