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
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
Enrollment
185
Q3M Information collection
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.
Time frame: 7 years
Subject overall survival
Overall survival status will be reported every 3 months
Time frame: 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
Time frame: 7 years
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Oncology Specialists SC
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Investigative Clinical Research of Indiana, LLC
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...and 49 more locations