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

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

Pharmaceutical study code

20130232

Information for the public

B/BE/15/BVW2 - Informatie fiche bestemd voor het publiek (voorbereid door de kennisgever)

B/BE/15/BVW2 - Fiche d'information destinée au public (préparée par le notifiant)

B/BE/15/BVW2 - Information for the public (written by the notifier)

Information related to the decision procedure

B/BE/15/BVW2 - Advice Biosafety Council

12 January 2016 - The Biosafety Council issues a positive advice (with conditions) for this trial

B/BE/15/BVW2 - Decision of the Federal Ministers (FINAL DECISION)

16 February 2016: The Federal Ministers give a final decision (positive) for this trial