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AzTrials

Carcinoma, Non-Small-Cell LungPhase 1NCT02592967

Safety & Immunogenicity of JNJ-64041757, Live-attenuated Double-deleted Listeria Immunotherapy, in Subjects With Non Small Cell Lung Cancer

A Phase 1 study testing JNJ-64041757 (Cohort 1A and 1B) and JNJ-64041757 (Cohort 2A and 2B) in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of JNJ-64041757 a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in which two virulence genes, which encode molecules that help cause disease, have been removed) when administered intravenously to participants with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
JNJ-64041757 (Cohort 1A and 1B) and JNJ-64041757 (Cohort 2A and 2B)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
9 sitesUnited States
Study dates
2 Dec 2015to 22 Oct 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Disease-related criteria for Part 1 and Part 2: 1) Histologically or cytologically documented non-small cell lung cancer (NSCLC) - adenocarcinoma; 2) Stage III b or IV disease; 3) Tested for presence of echinoderm microtubule-associated protein-like 4 anaplastic lymphoma kinase (EML4-ALK) rearrangement; 4) Received at least 2 prior lines of Food and Drug Administration (FDA)-approved systemic therapy, of which one therapy has to be a platinum-containing regimen OR failed or completed a first-line platinum-containing regimen and refused a second-line regimen despite being informed about the different therapeutic options and their specific clinical benefit by the investigator; the content of this informed consent discussion including the therapeutic options reviewed by the investigator needs to be documented and the subject needs to sign a specific consent form; Disease-related criteria for Cohort 2B only: 1) Mesothelin protein overexpression, defined by immunohistochemistry (IHC) as detection of the protein by greater than or equal (>=) 50 percent (%) of tumor cells on archived tumor material; 2) Primary tumor or metastatic lesion(s) amenable to tumor core biopsies
  • At least 1 measurable tumor lesion per RECIST v1.1 (exception: subjects in Part 1 are not required to present with measurable disease)
  • Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 to 1
  • At least 28 days since the last chemotherapy or immunotherapy prior to the first dose; at least 14 days since the last radiation prior to the first dose (exception: palliative radiotherapy for pain can be used greater than or equal to (>=) 7 days prior to or after infusion)

Who cannot join

  • Untreated brain metastases. Subjects must have completed treatment for brain metastasis, and be neurologically stable off steroids, for at least 28 days prior to first dose of study drug
  • History of listeriosis or vaccination with a listeria-based vaccine or prophylactic vaccine (eg, influenza, pneumococcal, diphtheria, tetanus, and pertussis [dTP/dTAP]) within 28 days of study treatment
  • Known allergy to both penicillin and trimethoprim/sulfamethoxazole. Participants who are allergic to only one of these antibiotics are allowed to enroll
  • Concurrent treatment with anti-Tumor necrosis factor alpha (TNF alpha) therapies, systemic corticosteroids (prednisone dose greater than [>]10 mg per day or equivalent) or other immune suppressive drugs within the 2 weeks prior to Screening. Steroids that are topical, inhaled, nasal (spray) or ophthalmic solution are permitted
  • Positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Study site

    Baltimore, Maryland

  • Study site

    Bethesda, Maryland

  • Study site

    Boston, Massachusetts

  • Study site

    Detroit, Michigan

  • Study site

    Duarte, California

  • Study site

    Houston, Texas

  • Study site

    Nashville, Tennessee

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    St Louis, Missouri

Other trials in United States

About this study

Official title: An Open Label Phase 1 Study of Safety and Immunogenicity of JNJ-64041757, A Live Attenuated Listeria Monocytogenes Immunotherapy, in Subjects With Non-Small Cell Lung Cancer

The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of JNJ-64041757 a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in which two virulence genes, which encode molecules that help cause disease, have been removed) when administered intravenously to participants with advanced (Stage IIIb) or metastatic (Stage IV) NSCLC (adenocarcinoma).

Read the detailed description

This is a first-in-human (FIH), Phase 1, open-label, multicenter and 2-part study in participants with advanced (Stage IIIb) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) (adenocarcinoma). Part 1 of study will be Dose Escalation phase to determine the recommended Phase 2 dose (RP2D) based on safety and pharmacodynamic assessments and Part 2 will be Dose Expansion Phase to evaluate 2 expansion cohorts (Cohort 2A and 2B) after the RP2D for JNJ-64041757 is determined in Part 1. The study will consist of a Screening Period (from signing of informed consent until immediately before the first dose), an open-label Treatment Period (from the first dose of study drug until the End-of-Treatment Visit); and a Post treatment Follow-up Period (after the End-of Treatment Visit until study discontinuation). Dose limiting toxicity (DLT) in part 1, antigen-specific T-cell response in part 2 and incidence of adverse events in both the parts will be primarily evaluated.

Being tested
JNJ-64041757 (Cohort 1A and 1B), JNJ-64041757 (Cohort 2A and 2B)
Keywords
Carcinoma, Non-Small-Cell Lung, JNJ-64041757, Listeria monocytogenes
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-64041757 (Cohort 1A and 1B)Biological

    JNJ-64041757 will be administered IV at a lower dose in Cohort 1A (1x10^8 colony forming units [CFU] ) and at a higher dose in Cohort 1B (1x10^9 CFU)

  • JNJ-64041757 (Cohort 2A and 2B)Biological

    JNJ-64041757 will be administered intravenously (IV) once every 21 days at the recommended dose as determined in Cohort 1A or 1B.

Study groups in NCT02592967
Study groupRoleWhat they receive
Cohort 1A and 1BExperimentalJNJ-64041757 will be administered intravenously (IV) once every 21 days.
Receives: Biological: JNJ-64041757 (Cohort 1A and 1B)
Cohort 2A and 2BExperimentalJNJ-64041757 will be administered intravenously (IV) once every 21 days.
Receives: Biological: JNJ-64041757 (Cohort 2A and 2B)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Incidence of Dose-limiting toxicity (DLT)

    Percentage of participants who experienced DLT will be evaluated. The DLT dose level is defined as an unacceptable level of toxicity as evidenced by a DLT rate of greater than or equal to (>=) 33%.

    Measured: First 21 days after the first infusion

  2. Part 2: Antigen-specific T-cell Response

    Biomarker analyses leukapheresis will be performed to evaluate immune responses to the vaccine after an single IV immunization.

    Measured: up to 1 year

  3. Part 1 and Part 2: Incidence of Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; suspected transmission of any infectious agent via a medicinal product and medically important. Incidence was defined as the number of participants who experienced an adverse event within their period of participation in this study. Severity of adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE).

    Measured: From signing of informed consent form to 30 days after last dose of study drug

Secondary outcomes (5)

  1. Part 1 and Part 2: Objective Response Rate (ORR)

    Objective response rate is defined as the percentage of participants who achieve complete response (CR) or partial response (PR), as assessed by the investigator.

    Measured: Baseline up to 30 days after last dose of study drug

  2. Part 1 and Part 2: Duration of Response (DOR)

    Duration of response will be calculated from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death.

    Measured: Baseline up to 30 days after last dose of study drug

  3. Part 1 and Part 2: Progression-free Survival (PFS)

    Progression-free survival is defined as the duration from the date of first dose of study drug until the date of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death, whichever comes first.

    Measured: Baseline up to 30 days after last dose of study drug

  4. Part 1 and Part 2: Blood Culture Assessment of JNJ-64041757

    This assessment will include the reporting of surveillance blood cultures (peripherally drawn, and through venous access device [if applicable]) for 1 year after the completion of JNJ-64041757 therapy.

    Measured: Periodically during treatment and up to one year after End of Treatment (EOT) visit

  5. Part 1 and Part 2: Shedding Profile of JNJ-64041757 From Cultured Samples of Feces, Urine, and Saliva

    The shedding profile of JNJ-64041757 will be studied in cultures of (1) feces by stool or rectal swab, (2) urine samples, and (3) saliva samples.

    Measured: During cycle 1 (up to 21 days of treatment period) and at EOT visit (within 30 days after last dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2015 (estimated)
  2. Study start2 Dec 2015
  3. Primary completion14 Aug 2018
  4. Study completion22 Oct 2018

Why it stopped: Development of JNJ-64041757 discontinued due to lack of efficacy. No further follow up data will be collected after October 22, 2018.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02592967
Sponsor's protocol ID
CR107667
Other IDs
64041757LUC1001
Status last verified
Jan 2025
First submitted
29 Oct 2015
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Publications

  • Brockstedt DG, Giedlin MA, Leong ML, Bahjat KS, Gao Y, Luckett W, Liu W, Cook DN, Portnoy DA, Dubensky TW Jr. Listeria-based cancer vaccines that segregate immunogenicity from toxicity. Proc Natl Acad Sci U S A. 2004 Sep 21;101(38):13832-7. doi: 10.1073/pnas.0406035101. Epub 2004 Sep 13.

    PubMed 15365184

  • Le DT, Dubenksy TW Jr, Brockstedt DG. Clinical development of Listeria monocytogenes-based immunotherapies. Semin Oncol. 2012 Jun;39(3):311-22. doi: 10.1053/j.seminoncol.2012.02.008.

    PubMed 22595054

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-64041757 (Cohort 1A and 1B) and JNJ-64041757 (Cohort 2A and 2B) in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Development of JNJ-64041757 discontinued due to lack of efficacy. No further follow up data will be collected after October 22, 2018.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Incidence of Dose-limiting toxicity (DLT) (time frame: First 21 days after the first infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02592967, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

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