A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene

Study title:

EU record number:

B/BE/16/BVW1

EudraCT number:

2014-005386-67

Treated organism:

Humans

Indication category:

Treatment of hepatocellular carcinoma (HCC) and metastatic liver tumors (non-HCC)

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)

Route of administration:

Intrahepatic injection

Locations in Belgium:

UCL Cliniques Universitaires Saint Luc (Bruxelles), Universitair Ziekenhuis Gent, Universitair Ziekenhuis Leuven Campus Gasthuisberg, Universitair Ziekenhuis Antwerpen

Foreseen duration:

April 2017 to December 2019

Information for the public

Information related to the decision procedure

B/BE/16/BVW1 - Advice Biosafety Council

13 December 2016 - The Biosafety Council issues a positive advice (with conditions) for this trial
B/BE/16/BVW1 - Decision of the Federal Ministers (FINAL DECISION)

3 March 2017: The Federal Ministers give a final decision (positive) for this trial