A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Noncentral Nervous System Tumors That are Amenable to Direct Injection

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Study title: 
A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Noncentral Nervous System Tumors That are Amenable to Direct Injection
Long title: 
A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Noncentral Nervous System Tumors That are Amenable to Direct Injection
Date receipt dossier: 
19 Mar 2019
EU record number: 
B/BE/19/BVW3
EudraCT number: 
2015-003645-25
Company / Sponsor: 
Amgen Ltd
Phase: 
I
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Pediatric subjects with advanced non-central nervous system tumors
Therapeutic approach: 
Immunotherapy
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)
Administered biological material: 
Recombinant HSV-1 D(ICP34,5 & ICP47)
Route of administration: 
Intralesional
Locations in Belgium: 
Universitair Ziekenhuis Gent
Nr of subjects: 
2 subjects foreseen in Belgium (10 subjects in Europe)
Foreseen duration: 
2 years 11 months, starting in June 2019
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

Information related to the decision procedure