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

Study title: 
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
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: 
5 nov 2020
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

Information for the public

Information related to the decision procedure