Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-28 @ 9:43 PM
Study NCT ID:
NCT02910557
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-14
First Post:
2016-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: