Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-010021
NCT ID: NCT02910557
Sponsor Protocol Number: 20130193
About this study
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
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jennifer Racz, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available