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

NCT ID: NCT03371381

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2018-10-09

Brief 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.

Detailed Description

This study evaluates safety and efficacy of JNJ-64041757 with nivolumab. The total study duration will be up to 3 years. It will consist of safety run-in and randomized phase which will comprise of Screening phase(Day(D) -28 to D -1),Treatment Phase,End of Adverse Event Evaluation Period (100 D after last dose of nivolumab)and Post-treatment Follow-up Phase(Every 3 Months). The primary hypothesis is that addition of JNJ-640417577 to nivolumab will result in higher objective response rate compared with nivolumab monotherapy in at least one of programmed death receptor ligand 1 subgroups in participants with relapsed or refractory StageIIIB or StageIV adenocarcinoma of lung. The study procedures include blood culture bacterial shedding assessments, pharmacokinetics, immunogenicity, and biomarkers. Safety will be monitored throughout study.

Conditions

Adenocarcinoma of Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nivolumab + JNJ-64041757

Phase 1b and Phase 2 Group A/Arm 1: Participants will receive separate intravenous (IV) infusions of nivolumab and JNJ-64041757 over approximately 60 minutes during each treatment cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study.

Group Type: EXPERIMENTAL

JNJ-64041757

Intervention Type: BIOLOGICAL

Participants will receive intravenous (IV) infusions of JNJ-64041757 over approximately 60 minutes during each treatment cycle.

Nivolumab

Intervention Type: DRUG

Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.

Nivolumab

Phase 2 Group B/Arm 2: Participants will receive intravenous (IV) infusions of nivolumab over approximately 60 minutes during each treatment cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study.

Group Type: ACTIVE_COMPARATOR

Nivolumab

Intervention Type: DRUG

Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.

Interventions

JNJ-64041757

Participants will receive intravenous (IV) infusions of JNJ-64041757 over approximately 60 minutes during each treatment cycle.

Intervention Type: BIOLOGICAL

Nivolumab

Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.

Intervention Type: DRUG

Other Intervention Names

JNJ-757

Eligibility Criteria

Inclusion 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

Exclusion 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Medical Oncology Associates, PS

Spokane, Washington, United States

AZ Maria Middelares

Ghent, , Belgium

Hosp. Univ. Quiron Dexeus

Barcelona, , Spain

Hosp. Gral. Univ. de Elche

Elche, , Spain

Complejo Hospitalario de Jaen

Jaén, , Spain

Hosp Regional Univ de Malaga

Málaga, , Spain

Hosp. Son Llatzer

Palma de Mallorca, , Spain

Hosp. Arnau de Vilanova de Valencia

Valencia, , Spain

Countries

United States; Belgium; Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-002543-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64041757LUC2002

Identifier Type: OTHER

Identifier Source: secondary_id

CR108232

Identifier Type: -

Identifier Source: org_study_id