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Notification report


Full notification file


General information

Notification Number
B/ES/20/18

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
16/12/2020

Title of the Project
A Phase 1/1b, Open-label Clinical Study of Intratumoral/Intralesional
Administration of V938 in Combination with Pembrolizumab
(MK-3475) in Participants with Advanced/Metastatic or Recurrent
Malignancies


Proposed period of release:
02/04/2021 to 15/04/2024

Name of the Institute(s) or Company(ies)
Merck Sharp & Dohme Corp., ;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Germany; Denmark; France;

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
RNA Virus

Identity of the GMO:
Order: Mononegavirales
Family: Paramyxoviridae
Genus: Orthoavulavirus
Species: Avian orthoavulavirus 1
Strain: Nonpathogenic lentogenic strain LaSota L289A


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Newcastle Disease VirusOrthoavulavirusavianorthoavulavirus 1N/ALaSota L289Aclass II, genotype II

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known