Registry Study for Talimogene Laherparepvec

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

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Key information

Conditions

Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Landeskrankenhaus Salzburg, Salzburg, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Information collection

Other

Q3M Information collection

Other names: Q3M Information collection

Primary outcomes

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.
Subject overall survival

Time frame: 7 years

Overall survival status will be reported every 3 months
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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2021
Study completion: 2021
First posted: Jun 24, 2014
Registry last updated: Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed