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

February 7, 2024 updated by: Amgen

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Medizinische Universitaet Graz
      • Linz, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz Elisabethinen
      • Salzburg, Austria, 5020
        • Terminated
        • Landeskrankenhaus Salzburg
      • Sankt Poelten, Austria, 3100
        • Recruiting
        • Universitaetsklinikum Sankt Poelten
  • Israel
      • Haifa, Israel, 3109601
        • Terminated
        • Rambam Medical Center
      • Ramat Gan, Israel, 5262000
        • Recruiting
        • Sheba Medical Center
  • Switzerland
      • Basel, Switzerland, 4052
        • Recruiting
        • Universitaetsspital Basel
      • Chur, Switzerland, 7000
        • Terminated
        • Kantonsspital Graubuenden
      • Zuerich Flughafen, Switzerland, 8058
        • Recruiting
        • Universitaetsspital Zuerich
  • United Kingdom
      • Cheltenham, United Kingdom, GL53 7AN
        • Recruiting
        • Cheltenham General Hospital
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden Hospital
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guys Hospital
      • Oxford, United Kingdom, OX3 7LJ
        • Recruiting
        • Churchill Hospital
      • Taunton, United Kingdom, TA1 5DA
        • Recruiting
        • Musgrove Park Hospital
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Recruiting
        • Mercy Medical Center
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Terminated
        • Jefferson City Medical Group PC
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • TriHealth Cancer Institute - Kenwood
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Terminated
        • University of Pittsburgh Medical Center Hillman Cancer Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • University of Tennessee Medical Center
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Terminated
        • University of Wisconsin Hospital and Clinics

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This postmarketing prospective cohort study will follow melanoma patients for up to 5 years after the first IMLYGIC dose in clinical practice. There is no experimental intervention, and the study population will receive standard-of-care treatment as determined by their treating physician.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate
Time Frame: 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.
Up to 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

August 10, 2017

Primary Completion (Estimated)

August 31, 2037

Study Completion (Estimated)

August 31, 2037

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimated)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130193

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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