Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection
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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. This data analysis for this study will also include data from 9 Amgen-sponsored clinical studies in adult participants with stage IIIB-IVM1c melanoma.
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
Actual Study Start Date :
August 10, 2017
Estimated Primary Completion Date :
September 1, 2027
Estimated Study Completion Date :
September 1, 2027
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Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This postmarketing prospective cohort study will follow melanoma patients for up to 5 years after the first IMLYGIC dose in clinical practice. There is no experimental intervention, and the study population will receive standard-of-care treatment as determined by their treating physician.
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
- Patient has a prior history of being a subject in an interventional clinical trial for IMLYGIC
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
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Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Amgen:
CTCAE - Common Terminology Criteria for Adverse Events
eCRF - electronic case report form
ECOG - Eastern Cooperative Oncology Group
EDC - electronic data capture
GM-CSF - human granulocyte macrophage colony-stimulating factor
HCP - health care provider
HSV-1 - herpes simplex virus type 1
ICF - informed consent form
ICP - infected cell protein
IEC - Independent Ethics Committee
IRB - Institutional Review Board
MedDRA - Medical Dictionary for Regulatory Activities
PFU - plaque-forming unit
qPCR - quantitative polymerase chain reaction
SmPC - Summary of Product Characteristics
USPI - United States Prescribing Information