Postmarketing Prospective Study of Melanoma Patients Treated With IMLYGIC® to Characterize Risk of Herpetic Infection

NCT ID: NCT02910557

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-10

Study Completion Date

2026-01-30

Brief Summary

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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

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Conditions

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Melanoma Herpetic Infection

Keywords

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IMLYGIC Talimogene Laherparepvec Herpetic Infection Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Corazon United States of America, LLC doing business as Life Clinical Trials

Coral Springs, Florida, United States

Site Status

Mercy Medical Center

Baltimore, Maryland, United States

Site Status

Jefferson City Medical Group PC

Jefferson City, Missouri, United States

Site Status

TriHealth Cancer Institute - Kenwood

Cincinnati, Ohio, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Site Status

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Medizinische Universitaet Graz

Graz, , Austria

Site Status

Ordensklinikum Linz Elisabethinen

Linz, , Austria

Site Status

Landeskrankenhaus Salzburg

Salzburg, , Austria

Site Status

Universitaetsklinikum Sankt Poelten

Sankt Pölten, , Austria

Site Status

Rambam Medical Center

Haifa, , Israel

Site Status

Sheba Medical Center

Ramat Gan, , Israel

Site Status

Universitaetsspital Basel

Basel, , Switzerland

Site Status

Kantonsspital Graubuenden

Chur, , Switzerland

Site Status

Universitaetsspital Zuerich

Zuerich Flughafen, , Switzerland

Site Status

Cheltenham General Hospital

Cheltenham, , United Kingdom

Site Status

Guys Hospital

London, , United Kingdom

Site Status

Royal Marsden Hospital

London, , United Kingdom

Site Status

Churchill Hospital

Oxford, , United Kingdom

Site Status

Musgrove Park Hospital

Taunton, , United Kingdom

Site Status

Countries

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United States Austria Israel Switzerland United Kingdom

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20130193

Identifier Type: -

Identifier Source: org_study_id