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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03371381
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Adenocarcinoma of Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JNJ-64041757 — BIOLOGICAL
    Participants will receive intravenous (IV) infusions of JNJ-64041757 over approximately 60 minutes during each treatment cycle.
  • Nivolumab — DRUG
    Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.

Study Details

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.

Key Dates

Start date
Jan 2, 2018
Status verified
Jan 2025
Primary completion
Oct 9, 2018
Completion
Oct 9, 2018

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Phase 1b: Percentage of Participants With Objective Response [ Time Frame: Up to 6.8 Months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287-
Tennessee Oncology, PLLCNashvilleTennessee37201-
Medical Oncology Associates, PSSpokaneWashington99208-1129-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDTennessee Oncology, PLLC· Nashville, TNMedical Oncology Associates, PS· Spokane, WA

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