B/BE/20/BVW5 - Summary Notification Information Format (SNIF) - 1Public information presented according to the provisions of Directive 2001/18/EC (related to GAd20)
Long title
An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Nous-PEV, with pembrolizumab, in Patients with Unresectable Stage III / IV Cutaneous Melanoma and with Stage IV NSCLC (PDL1≥ 50%)
Date receipt dossier
EU record number
B/BE/20/BVW5
EudraCT number
2019-004759-35
Company / Sponsor
Nouscom Srl
Phase
Ib
Treated organism
Humans
Indication category
Cancer therapy
Disease
​Treatment of skin and lung cancer
Therapeutic approach
Immunotherapy
Genetic modification
The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the PEV neoantigens gene; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the neoantigens gene.
Method of transfer of nucleic acid of interest
Non-replicating recombinant viruses
Administered biological material
Genetically modified viruses
Route of administration
Intramuscular
Locations in Belgium
Universitair Ziekenhuis Leuven, Grand Hôpital de Charleroi
Nr of subjects
Planned number of patients to be enrolled in Belgium is 11
Foreseen duration
The study is expected to start in Belgium in Feb-2021 and to be completed on 31-Mar-2023
Type of procedure
Contained use and Deliberate release
Current status
Authorized