The FPS Public Health and the FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified drug Nous-PEV (formed by the experimental drugs GAd-PEV and MVA-PEV) for the treatment of certain lung and skin cancers. The public consultation will run from 10 November 2020 to 10 December 2020.
For each clinical trial application related to the use of genetically modified organisms, the authority organises a 30-day public consultation (in accordance with the Royal Decree of 21 February 2005 (WEB)). This gives you the opportunity, as a citizen, to share your opinion on the clinical trial application for the genetically modified drug Nous-PEV (formed by the experimental drugs GAd-PEV and MVA-PEV) for the treatment of certain lung and skin cancers.
This clinical trial will study a new treatment, the Nous-PEV vaccine, in combination with a standard treatment - pembrolizumab (Keytruda®) - for the treatment of skin and lung cancers that cannot be cured by surgery alone. Nous-PEV is given with the intention of curing or alleviating an existing cancer. It is thus a therapeutic cancer vaccine. It will be administered in combination with pembrolizumab. It is composed of two vaccines administered sequentially: GAd-PEV (primary vaccination) and MVA-PEV (booster vaccination). GAd-PEV and MVA-PEV are genetically modified organisms (GMOs).
The study will besides efficacity also examine how well people tolerate Nous-PEV and whether it is safe to take it in combination with pembrolizumab.
The clinical trial will take place at the UZ Leuven and the Grand Hôpital de Charleroi.
How can I share my opinion?
The public consultation runs until 10 December 2020 inclusive. You can now access the various data in the application file, as well as an online form (HTML) (Dutch or French) to send your comments or ask your questions about this file.
General information on public consultations on GMOs (HTML) (French or Dutch)