A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene

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Study title: 
A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene
EU record number: 
B/BE/16/BVW1
EudraCT number: 
2014-005386-67
Company / Sponsor: 
Amgen Ltd
Treated organism: 
Humans
Indication category: 
Treatment of hepatocellular carcinoma (HCC) and metastatic liver tumors (non-HCC)
Genetic modification: 
Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
Method of transfer of nucleic acid of interest: 
Herpes simplex virus 1 (HSV-1)
Route of administration: 
Intrahepatic injection
Locations in Belgium: 
UCL Cliniques Universitaires Saint Luc (Bruxelles), Universitair Ziekenhuis Gent, Universitair Ziekenhuis Leuven Campus Gasthuisberg, Universitair Ziekenhuis Antwerpen
Foreseen duration: 
April 2017 to December 2019

Information related to the decision procedure