COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2017-08-10
Study Completion:2026-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT02910557

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient has provided written informed consent
  2. * Patient is an adult (≥ 18 years of age at the time of informed consent) with a diagnosis of melanoma
  3. * Patient enrolled within 1 month of receiving the first dose of IMLYGIC for the treatment of melanoma
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Corazon United States of America, LLC doing business as Life Clinical Trials
Coral Springs, Florida, 33076
United States
Mercy Medical Center
Baltimore, Maryland, 21202
United States
Jefferson City Medical Group PC
Jefferson City, Missouri, 65109
United States
TriHealth Cancer Institute - Kenwood
Cincinnati, Ohio, 45242
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
Intermountain Medical Center
Murray, Utah, 84107
United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-08-10
Study Completion Date2026-01-30

Study Record Updates

Study Start Date2017-08-10
Study Completion Date2026-01-30

Terms related to this study

Keywords Provided by Researchers

  • IMLYGIC
  • Talimogene Laherparepvec
  • Herpetic
  • Infection Melanoma

Additional Relevant MeSH Terms

  • Melanoma
  • Herpetic Infection