Registry Study for Talimogene Laherparepvec

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial

Intervention / Treatment
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* Other: Information collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Previously treated with T-VEC<br>Received at least 1 dose of talimogene laherparepvec on Amgen or BioVEX-sponsored clinical trial | Other: Information collection<br>* Q3M Information collection<br>* Other names: Q3M Information collection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Talimogene Laherparepvec Related Adverse Events | 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. | 7 years | 
| Subject overall survival | Overall survival status will be reported every 3 months | 7 years | 
| Use of subsequent anti-cancer therapy | 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 | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, talimogene laherparepvec