We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02910557
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : April 5, 2023
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Melanoma Herpetic Infection

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 10, 2017
Estimated Primary Completion Date : August 31, 2037
Estimated Study Completion Date : August 31, 2037

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910557


Contacts
Layout table for location contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02910557    
Other Study ID Numbers: 20130193
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: April 5, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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.
URL: https://www.amgen.com/datasharing

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
IMLYGIC
Talimogene Laherparepvec
Herpetic
Infection Melanoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Melanoma
Disease Attributes
Pathologic Processes
Neuroendocrine Tumors
 Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas