A phase II study evaluating the efficacy and the safety of first-line chemotherapy combined with TG4010 and nivolumab in patients with advanced non-squamous Non-Small-Cell Lung Cancer (NSCLC)

EU record number

B/BE/17/BVW1

EudraCT number

2016-005115-41

Treated organism

Humans

Indication category

Cancer therapy

Disease

Use as a chemotherapy in combination with the monoclonal antibody Nivolumab in patients with advanced non-squamous Non-Small-Cell Lung Cancer (NSCLC)

Genetic modification

Sequences coding for human mucine 1 (MUC1) antigen and interleukin-2 (IL2)

Method of transfer of nucleic acid of interest

Attenuated Vaccinia Virus (Ankara Strain)

Route of administration

Subcutaneous

Locations in Belgium

Centre Hospitalier de l’Ardenne, Libramont

Nr of subjects

5 patients foreseen in Belgium

Foreseen duration

2 years

Type of procedure

Contained use and Deliberate release

Information for the public

B/BE/17/BVW1 - Summary Notification Information format (SNIF)

Public information presented according to the provisions of Directive 2001/18/EC

B/BE/17/BVW1 - Information publique (préparée par le notifiant)

Information related to the decision procedure

B/BE/17/BVW1 - Advice Biosafety Council

5 September 2017 - The Biosafety Council issues a positive advice (with conditions) for this trial

B/BE/17/BVW1 - Decision of the Federal Ministers (FINAL DECISION)

28 November 2017: The Federal Ministers give a final decision (positive) for this trial