Status:
TERMINATED
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Adenocarcinoma of Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
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 Sc...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03371381
Start Date
January 2 2018
End Date
October 9 2018
Last Update
February 4 2025
Active Locations (10)
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1
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
2
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37201
3
Medical Oncology Associates, PS
Spokane, Washington, United States, 99208-1129
4
AZ Maria Middelares
Ghent, Belgium, 9000