An Open-label Randomized Phase 1b/2 Study of the Efficacy and Safety of JNJ-64041757, a Live Attenuated Listeria monocytogenes Immunotherapy, in Combination with Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced Adenocarcinoma of the Lung

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Study title: 
An Open-label Randomized Phase 1b/2 Study of the Efficacy and Safety of JNJ-64041757, a Live Attenuated Listeria monocytogenes Immunotherapy, in Combination with Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced Adenocarcinoma of the Lung
Date receipt dossier: 
29 mar 2018
EudraCT number: 
2016-002543-41
Company / Sponsor: 
Janssen-Cilag International NV
Phase: 
Ib/II
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Advanced adenocarcinoma of the lung
Therapeutic approach: 
Immunotherapy
Genetic modification: 
Genetically modified, live attenuated Listeria monocytogenes (Lm ΔactA/ΔinlB)
Method of transfer of nucleic acid of interest: 
not applicable
Administered biological material: 
Genetically modified, attenuated Listeria monocytogenes (Lm ΔactA/ΔinlB) - JNJ-(64041)757
Route of administration: 
Intravenous
Locations in Belgium: 
AZ Maria Middelares, Gent
Nr of subjects: 
9
Type of procedure: 
Contained use only
Current status: 
Authorized