A Phase 1b Study of Talimogene Laherparepvec in Combination With Atezolizumab in Subjects With Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases

Study title: 
A Phase 1b Study of Talimogene Laherparepvec in Combination With Atezolizumab in Subjects With Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases
EU record number: 
B/BE/17/BVW2
EudraCT number: 
2015-005480-16
Company / Sponsor: 
Amgen Ltd
Phase: 
Ib
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Subjects with triple negative breast cancer and colorectal cancer with liver metastases
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: 
Intrahepatic injection
Locations in Belgium: 
UCL Cliniques Universitaires Saint Luc (Bruxelles), Universitair Ziekenhuis Gent
Nr of subjects: 
5 subjects foreseen in Belgium (36 subjects for the whole clinical trial)
Foreseen duration: 
January 2018 to December 2021
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

Information for the public

Information related to the decision procedure