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

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

© Sciensano - Version 1.0 (20260902.1)