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Protocol No. UW17089

Principal Investigator Neuman, Heather

Phase N/A (Cancer Control)

Age Group Adult

Scope National

Sponsor Type Industry

Title A Postmarketing Prospective Cohort Study of Melanoma Patients Treated with IMLYGIC (Talimogene Laherparepvec) in clinical Practice to Characterize the Risk of Herpetic Infection Among Patients, Close Contacts, and Health Care Providers; and Long-term Safety in Treated Patients

Objective The purpose of this study is to learn more about whether patients who are treated with IMILYGIC(Talimogene Laherparepvec) can get a herpes simplex virus type 1 infection from this drug and whether these patients can pass on the infection to their close contacts(i.e., people in the patients household, caregivers, sex partners, and anyone sharing the same bed) or to health care providers

Treatment This is an observational study, you do no have to take any investigational drugs or change your medications. If you agree to participate in this study, you will be advised to see your doctor if you develop a suspected herpetic lesion during the study period. With your consent, your doctor may use a swab to collect a sample from any lesion that is suspected to be a herpetic infection. The sample may then be tested to check if the virus in the lesion was from a normal herpes simplex virus type 1 or from IMLYGIC(Talimogene Laherparepvec)

Description A postmarketing prospective cohort study of melanona patients treated with IMLYGIC(Talimogene Laherparepvec)

Key Eligibility
  • 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: Patient has a prior history of being a subject in an interventional clinical trial for IMLYGIC(Talimogene Laherparepvec)

  • Applicable Disease Sites Melanoma/Skin cancer

    Status Open

    Participating Institutions UW Hospital and Clinics