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

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ClinicalTrials.gov Identifier: NCT02910557
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC® (Talimogene Laherparepvec) in Clinical Practice to Characterize the Risk of Herpetic Infection Among Patients, Close Contacts, and Health Care Providers; and Long-term Safety in Treated Patients

Condition or disease
Melanoma Herpetic Infection

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Study Type : Observational
Estimated Enrollment : 920 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 28, 2024
Estimated Study Completion Date : August 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma




Primary Outcome Measures :
  1. Incidence Rate [ Time Frame: Up to 5 years ]
    Estimate the incidence rate of herpetic infection with detection of talimogene laherparepvec DNA among patients for up to 5 years after the first IMLYGIC dose.


Secondary Outcome Measures :
  1. Herpectic Infection with T-VEC for Close Contacts and HCPs [ Time Frame: Through study completion, average of 5yrs. ]
    Count the number of herpetic infections with detection of talimogene laherparepvec DNA among close contacts and HCPs.

  2. Incidence of Herpetic Infection with TVEC in Patients during treatment [ Time Frame: Through treatment period, upto 1yr ]
    Estimate the incidence rate of herpetic infection with detection of talimogene laherparepvec DNA among patients during treatment with IMLYGIC.

  3. Incidence of Herpetic Infection with TVEC in Patients after treatment [ Time Frame: Through study completion, average of 5yrs. ]
    Estimate the incidence rate of herpetic infection with detection of talimogene laherparepvec DNA among patients after discontinuation of IMLYGIC.

  4. Incidence of HSV-1 DNA in Patients during Treatment [ Time Frame: Through treatment period, upto 1yr ]
    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 5yrs. ]
    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 5yrs. ]
    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 5yrs. ]
    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 5yrs. ]
    Incidence of adverse events and serious adverse events during and after treatment with IMLYGIC

  9. Overall Survival [ Time Frame: Through study completion, average of 5yrs. ]
    Survival is defined by the time to death from the date of the first use of IMLYGIC.



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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


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
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, Missouri
Research Site Recruiting
Jefferson City, Missouri, United States, 65109
United States, Ohio
Research Site Recruiting
Cincinnati, Ohio, United States, 45220
United States, Pennsylvania
Research Site Completed
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Research Site Recruiting
Knoxville, Tennessee, United States, 37920
United States, Utah
Research Site Recruiting
Murray, Utah, United States, 84107
United States, Wisconsin
Research Site Completed
Madison, Wisconsin, United States, 53792
Austria
Research Site Recruiting
Graz, Austria, 8036
Research Site Recruiting
Linz, Austria, 4020
Research Site Recruiting
Salzburg, Austria, 5020
Research Site Recruiting
Sankt Poelten, Austria, 3100
Israel
Research Site Recruiting
Haifa, Israel, 3109601
Research Site Recruiting
Ramat Gan, Israel, 5262000
Switzerland
Research Site Recruiting
Basel, Switzerland, 4052
Research Site Completed
Chur, Switzerland, 7000
Research Site Recruiting
Zuerich, Switzerland, 8091
United Kingdom
Research Site Recruiting
Cheltenham, United Kingdom, GL53 7AN
Research Site Recruiting
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02910557     History of Changes
Other Study ID Numbers: 20130193
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:
HSV-1 - herpes simplex virus type 1
CTCAE - Common Terminology Criteria for Adverse Events
eCRF - electronic case report form
ECOG - Eastern Cooperative Oncology Group
EDC - electronic data capture
GM-CSF - human granulocyte macrophage colony-stimulating factor
HCP - health care provider
ICF - informed consent form
ICP - infected cell protein
IEC - Independent Ethics Committee
IRB - Institutional Review Board
MedDRA - Medical Dictionary for Regulatory Activities
PFU - plaque-forming unit
qPCR - quantitative polymerase chain reaction
SmPC - Summary of Product Characteristics
USPI - United States Prescribing Information

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Sargramostim
Immunologic Factors
Physiological Effects of Drugs