A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab for Treatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (20130232)

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Study title: 
A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab for Treatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (20130232)
EU record number: 
B/BE/15/BVW2
EudraCT number: 
2015-003011-38
Pharmaceutical study code: 
20130232
Company / Sponsor: 
Amgen Ltd
Phase: 
I and III
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Metastatic Squamous Cell Carcinoma of the Head and Neck
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: 
Institut Jules Bordet (Bruxelles), GasthuisZusters Antwerpen (Campus Sint-Augustinus Wilrijk)
Nr of subjects: 
270 patients in Europe, with a max. of 10 in Belgium
Foreseen duration: 
January 2016 to February 2022
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

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