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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02910557
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Austria, Israel, Switzerland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma, Herpetic Infection
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mercy Medical Center, Baltimore, Maryland

Status

Recruiting

Address

Mercy Medical Center

Baltimore, Maryland, 21202

Jefferson City Medical Group PC, Jefferson City, Missouri

Status

Terminated

Address

Jefferson City Medical Group PC

Jefferson City, Missouri, 65109

TriHealth Cancer Institute - Kenwood, Cincinnati, Ohio

Status

Completed

Address

TriHealth Cancer Institute - Kenwood

Cincinnati, Ohio, 45242

Pittsburgh, Pennsylvania

Status

Terminated

Address

University of Pittsburgh Medical Center Hillman Cancer Center

Pittsburgh, Pennsylvania, 15213

University of Tennessee Medical Center, Knoxville, Tennessee

Status

Recruiting

Address

University of Tennessee Medical Center

Knoxville, Tennessee, 37920

Intermountain Medical Center, Murray, Utah

Status

Recruiting

Address

Intermountain Medical Center

Murray, Utah, 84107

Madison, Wisconsin

Status

Terminated

Address

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792

International Sites

Medizinische Universitaet Graz, Graz, Austria

Status

Recruiting

Address

Medizinische Universitaet Graz

Graz, , 8036

Ordensklinikum Linz Elisabethinen, Linz, Austria

Status

Recruiting

Address

Ordensklinikum Linz Elisabethinen

Linz, , 4020

Landeskrankenhaus Salzburg, Salzburg, Austria

Status

Terminated

Address

Landeskrankenhaus Salzburg

Salzburg, , 5020

Universitaetsklinikum Sankt Poelten, Sankt Poelten, Austria

Status

Recruiting

Address

Universitaetsklinikum Sankt Poelten

Sankt Poelten, , 3100

Rambam Medical Center, Haifa, Israel

Status

Terminated

Address

Rambam Medical Center

Haifa, , 3109601

Sheba Medical Center, Ramat Gan, Israel

Status

Recruiting

Address

Sheba Medical Center

Ramat Gan, , 5262000

Universitaetsspital Basel, Basel, Switzerland

Status

Recruiting

Address

Universitaetsspital Basel

Basel, , 4052

Kantonsspital Graubuenden, Chur, Switzerland

Status

Terminated

Address

Kantonsspital Graubuenden

Chur, , 7000

Universitaetsspital Zuerich, Zuerich Flughafen, Switzerland

Status

Recruiting

Address

Universitaetsspital Zuerich

Zuerich Flughafen, , 8058

Cheltenham General Hospital, Cheltenham, United Kingdom

Status

Recruiting

Address

Cheltenham General Hospital

Cheltenham, , GL53 7AN

Guys Hospital, London, United Kingdom

Status

Recruiting

Address

Guys Hospital

London, , SE1 9RT

Royal Marsden Hospital, London, United Kingdom

Status

Recruiting

Address

Royal Marsden Hospital

London, , SW3 6JJ

Churchill Hospital, Oxford, United Kingdom

Status

Recruiting

Address

Churchill Hospital

Oxford, , OX3 7LJ

Musgrove Park Hospital, Taunton, United Kingdom

Status

Recruiting

Address

Musgrove Park Hospital

Taunton, , TA1 5DA

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