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Registry Study for Talimogene Laherparepvec

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ClinicalTrials.gov Identifier: NCT02173171
Recruitment Status : Enrolling by invitation
First Posted : June 24, 2014
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials

Condition or disease Intervention/treatment
Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial Other: Information collection

Detailed Description:
A registry study is to evaluate the overall survival, use of subsequent anti-cancer therapy, and the long-term safety of subjects who have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type. Follow-Up will occur every 3 months.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 340 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials
Actual Study Start Date : April 27, 2010
Estimated Primary Completion Date : March 23, 2023
Estimated Study Completion Date : March 23, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Previously treated with T-VEC
Received at least 1 dose of talimogene laherparepvec on Amgen or BioVEX-sponsored clinical trial
Other: Information collection
Q3M Information collection
Other Name: Q3M Information collection




Primary Outcome Measures :
  1. Talimogene Laherparepvec Related Adverse Events [ Time Frame: 7 years ]
    Long-term safety of talimogene laherparepvec will be assessed by reporting of related adverse events every 3 months. Related serious adverse events will be reported within 24 hours following investigator's knowledge of the event.

  2. Subject overall survival [ Time Frame: 7 years ]
    Overall survival status will be reported every 3 months

  3. Use of subsequent anti-cancer therapy [ Time Frame: 7 years ]
    The use of subsequent anti-cancer therapy, for the tumor indication in the prior Amgen or BioVEX-sponsored clinical trial, including retreatment with marketed talimogene laherparepvec for approved indication in subjects previously enrolled in Amgen or BioVEX-sponsored talimogene laherparepvec clinical trials, will be monitored



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have received at least one dose of talimogene laherparepvec in an Amgen or BioVEX-sponsored clinical trial.
Criteria

Inclusion Criteria:

All subjects must provide informed consent prior to initiation of any study activities.

All subjects must have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type and must have discontinued treatment and participation, including long-term follow-up (if applicable) in that trial.

Exclusion Criteria:

Subjects currently receiving talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial.

Subject currently participating, including for long-term follow-up (if applicable), in other Amgen-sponsored talimogene laherparepvec clinical trial.


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): NCT02173171


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Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02173171     History of Changes
Other Study ID Numbers: 20120139
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
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:

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.

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

URL: https://www.amgen.com/datasharing

Keywords provided by Amgen:
Melanoma
talimogene laherparepvec