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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02910557

Enrollment

187

Registered

2016-09-22

Start date

2017-08-10

Completion date

2026-01-30

Last updated

2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpetic Infection, Melanoma

Keywords

IMLYGIC, Talimogene Laherparepvec, Herpetic, Infection Melanoma

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence Rate	Up to 5 years	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

Measure	Time frame	Description
Incidence of Herpetic Infection with T-VEC in Patients During Treatment	Through treatment period, up to 1 year	Estimate the incidence rate of herpetic infection with detection of T-VEC DNA among patients during treatment with IMLYGIC.
Incidence of Herpetic Infection with T-VEC in Patients After Treatment	Through study completion, average of 5 years	Estimate the incidence rate of herpetic infection with detection of T-VEC DNA among patients after discontinuation of IMLYGIC.
Incidence of Herpes Simplex Virus 1 (HSV-1) DNA in Patients During Treatment	Through treatment period, up to 1 year	Estimate the incidence rate of herpetic infection with detection of wild-type HSV-1 DNA among patients during treatment with IMLYGIC.
Incidence of HSV-1 DNA in Patients After Treatment	Through study completion, average of 5 years	Estimate the incidence rate of herpetic infection with detection of wild-type HSV-1 DNA among patients after discontinuation of IMLYGIC.
Patient Demographics	Through study completion, average of 5 years	The following baseline variables will be recorded: sex, age, Eastern Cooperative Oncology Group (ECOG) performance status.
Use of Drug Therapies	Through study completion, average of 5 years	Describe the use of IMLYGIC, other anti-cancer therapy, anti-herpetic therapy.
Incidence of Adverse Events and Serious Adverse Events in Patients	Through study completion, average of 5 years	Incidence of adverse events and serious adverse events during and after treatment with IMLYGIC
Herpectic Infection with T-VEC DNA for Close Contacts and Healthcare Providers (HCPs)	Through study completion, average of 5 years	Count the number of herpetic infections with detection of T-VEC DNA among close contacts and HCPs.
Overall Survival	Through study completion, average of 5 years	Survival is defined by the time to death from the date of the first use of IMLYGIC.

Countries

Austria, Israel, Switzerland, United Kingdom, United States

Contacts

STUDY_DIRECTORMD

Amgen

Outcome results