Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial
Conditions
Keywords
Melanoma, talimogene laherparepvec
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
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.
Interventions
OTHERInformation collection
Q3M Information collection
Sponsors
Amgen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Talimogene Laherparepvec Related Adverse Events | 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. |
| Subject overall survival | 7 years | Overall survival status will be reported every 3 months |
| Use of subsequent anti-cancer therapy | 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 |
Countries
Austria, Canada, France, Germany, Greece, Hungary, Italy, Poland, Russia, South Africa, South Korea, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed