An Efficacy and Safety Study of JNJ-64041757, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Nivolumab Versus Nivolumab Monotherapy in Participants With Advanced Adenocarcinoma of the Lung

Study summary

The purpose of this study is to evaluate whether the efficacy of JNJ-757 combined with nivolumab is better than the efficacy of nivolumab monotherapy for participants with mesothelin-positive relapsed/refractory Stage IIIB or Stage IV adenocarcinoma of the lung. The open-label study comprises of two parts i.e. Phase 1b (safety run-in) and Phase 2. Phase1b consists of 1 arm whereas Phase 2 is randomized into 2 groups i.e. Group A and Group B.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedJNJ-64041757 and Nivolumab

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV · Recurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 4, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?10 U.S. locations

Locations may change over time.

Who runs it?Janssen Research & Development, LLC

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Janssen Research & Development, LLC
Interventions being studied: Biological: JNJ-64041757; Drug: Nivolumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Metastatic or stage IV→Recurrent or relapsed→Resistant or refractory→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Disease-related criteria: Histologically documented adenocarcinoma of the lung; Stage IIIB or Stage IV disease; Biopsy material available for central assessment of programmed death receptor ligand 1 (PD-L1) and mesothelin
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Progressive disease during or after platinum-based doublet chemotherapy
A woman of childbearing potential must have a negative serum or urine pregnancy test within 14 days before the first dose of nivolumab
Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Reasons someone may not be able to joinExclusion criteria

Tumor with activating epidermal growth factor receptor (EGFR) mutation or ALK translocation
More than 1 prior line of chemotherapy for metastatic disease (Phase 2)
History of disallowed therapies, as follows: In Phase 1b only: Prior exposure to anti-programmed death receptor-1(PD1), anti programmed death receptor ligand 1 (PD-L1), anti-programmed death receptor ligand 2 (PD-L2), anti-CD137, or anti-cytotoxic T lymphocyte associated antigen 4 (CTLA-4) antibody within 28 days before the first dose of study agent, In Phase 2 only: Prior exposure to anti-PD1, anti PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated antigen 4 (CTLA-4) antibody, History of listeriosis or vaccination with a Listeria-based vaccine or prophylactic vaccine within 28 days before the first dose of study agent, Chemotherapy within 28 days before the first dose of study agent, Radiation within 14 days before the first dose of study agent
History of any other condition that may require the initiation of anti-tumor necrosis factor alpha (TNF alpha) therapies or other immunosuppressant medications during the study
Active second malignancy within 2 years prior to Cycle 1 Day 1 (Phase 1b) or randomization (Phase 2)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
Tennessee Oncology, PLLCNashville, Tennessee
Medical Oncology Associates, PSSpokane, Washington
AZ Maria MiddelaresGhent
Hosp. Univ. Quiron DexeusBarcelona
Hosp. Gral. Univ. de ElcheElche
Complejo Hospitalario de JaenJaén
Hosp Regional Univ de MalagaMálaga
Hosp. Son LlatzerPalma de Mallorca
Hosp. Arnau de Vilanova de ValenciaValencia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 4, 2025. Always confirm current availability with the study team.

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