A phase 2 clinical trial with Talimogene Laherparepvec

Study title: 
A phase 2 clinical trial with Talimogene Laherparepvec
Long title: 
A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated with Talimogene laherparepvec
EU record number: 
B/BE/14/BVW1
EudraCT number: 
2013-005552-15
Pharmaceutical study code: 
20120325
Company / Sponsor: 
Amgen Ltd
Phase: 
II
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Melanoma
Therapeutic approach: 
Immunotherapy
Genetic modification: 
Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (GM-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)
Administered biological material: 
Recombinant HSV-1 D(ICP34,5 & ICP47)
Route of administration: 
Intralesional
Locations in Belgium: 
UZ Gent, Cliniques Universitaires St Luc (Brussels), Institut Bordet (Brussels), CHU de Liège Contained Use: CHU Sart Tilman, Liège + UCL St Luc
Nr of subjects: 
110 subjects worldwide, 10 subjects foreseen in Belgium
Foreseen duration: 
2 years
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

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