A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresected, Stage IIIB to IVM1c Melanoma

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Study title: 
A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresected, Stage IIIB to IVM1c Melanoma
EU record number: 
B/BE/15/BVW1
EudraCT number: 
2014-000185-22
Pharmaceutical study code: 
20110265
Company / Sponsor: 
Amgen Ltd
Phase: 
I and III
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 injection into injectable cutaneous, subcutaneous, and nodal lesions
Locations in Belgium: 
UZ Gent, Cliniques Universitaires St Luc (Brussels), UZ Brussels, CHU de Liège
Nr of subjects: 
660 subjects worldwide, 35 subjects foreseen in Belgium
Foreseen duration: 
6 years
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

Information related to the decision procedure