Observational study of melanoma patients treated with IMLYGIC and risk of herpetic infection
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
This study is testing if melanoma patients treated with IMLYGIC are at a higher risk of getting herpes infections and looking at the long-term safety of the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Amgen Industry-sponsored |
| Locations | 23 sites (Coral Springs, Florida and 22 other locations) |
| Trial ID | NCT02910557 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on melanoma patients who have been treated with IMLYGIC (Talimogene Laherparepvec) to assess the risk of herpetic infection. It aims to detect Talimogene Laherparepvec DNA among patients, their close contacts, and healthcare providers. The study will also evaluate the long-term safety of IMLYGIC treatment for up to five years following the first dose. By monitoring these patients, researchers hope to gather valuable data on the incidence of herpetic infections associated with this treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adult melanoma patients who have recently started treatment with IMLYGIC.
Not a fit: Patients who have previously participated in an interventional clinical trial for IMLYGIC will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety profile of IMLYGIC and help mitigate the risk of herpetic infections in melanoma patients.
How similar studies have performed: While this study is observational and focuses on postmarketing data, similar studies have previously provided valuable safety information for other treatments, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Coral Springs, Florida and 22 other locations
- Corazon United States of America, LLC doing business as Life Clinical Trials — Coral Springs, Florida, United States (Recruiting)
- Mercy Medical Center — Baltimore, Maryland, United States (Recruiting)
- Jefferson City Medical Group PC — Jefferson City, Missouri, United States (Terminated)
- TriHealth Cancer Institute - Kenwood — Cincinnati, Ohio, United States (Terminated)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Terminated)
- Allegheny Health Network — Pittsburgh, Pennsylvania, United States (Recruiting)
- University of Tennessee Medical Center — Knoxville, Tennessee, United States (Recruiting)
- Intermountain Medical Center — Murray, Utah, United States (Recruiting)
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States (Terminated)
- Medizinische Universitaet Graz — Graz, Austria (Recruiting)
- Ordensklinikum Linz Elisabethinen — Linz, Austria (Recruiting)
- Landeskrankenhaus Salzburg — Salzburg, Austria (Terminated)
- Universitaetsklinikum Sankt Poelten — Sankt Poelten, Austria (Recruiting)
- Rambam Medical Center — Haifa, Israel (Terminated)
- Sheba Medical Center — Ramat Gan, Israel (Recruiting)
- Universitaetsspital Basel — Basel, Switzerland (Recruiting)
- Kantonsspital Graubuenden — Chur, Switzerland (Terminated)
- Universitaetsspital Zuerich — Zuerich Flughafen, Switzerland (Recruiting)
- Cheltenham General Hospital — Cheltenham, United Kingdom (Recruiting)
- Guys Hospital — London, United Kingdom (Recruiting)
- Royal Marsden Hospital — London, United Kingdom (Recruiting)
- Churchill Hospital — Oxford, United Kingdom (Recruiting)
- Musgrove Park Hospital — Taunton, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Amgen Call Center
- Email: medinfo@amgen.com
- Phone: 866-572-6436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.