Clinical trial · Observational
Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Herpetic Infection | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence Rate
- timeFrame
- Up to 5 years
- description
- 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 (9)
- measure
- Herpectic Infection with T-VEC DNA for Close Contacts and Healthcare Providers (HCPs)
- timeFrame
- Through study completion, average of 5 years
- description
- Count the number of herpetic infections with detection of T-VEC DNA among close contacts and HCPs.
- measure
- Incidence of Herpetic Infection with T-VEC in Patients During Treatment
- timeFrame
- Through treatment period, up to 1 year
- description
- Estimate the incidence rate of herpetic infection with detection of T-VEC DNA among patients during treatment with IMLYGIC.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available