A phase 2 clinical trial with Talimogene Laherparepvec

Long title

A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated with Talimogene laherparepvec

EU record number

B/BE/14/BVW1

EudraCT number

2013-005552-15

Company / Sponsor

Amgen Ltd

Phase

II

Treated organism

Humans

Indication category

Cancer therapy

Disease

Melanoma

Therapeutic approach

Immunotherapy

Genetic modification

Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (GM-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

UZ Gent, Cliniques Universitaires St Luc (Brussels), Institut Bordet (Brussels), CHU de Liège

Contained Use: CHU Sart Tilman, Liège + UCL St Luc

Nr of subjects

110 subjects worldwide, 10 subjects foreseen in Belgium

Foreseen duration

2 years

Type of procedure

Contained use and Deliberate release

Current status

Authorized

Pharmaceutical study code

20120325