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    Clinical Trial Results:
    An Open-label Randomized Phase 1b/2 Study of the Efficacy and Safety of JNJ-64041757, a Live Attenuated Listeria monocytogenes Immunotherapy, in Combination with Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced Adenocarcinoma of the Lung

    Summary
    EudraCT number
    2016-002543-41
    Trial protocol
    ES   BE  
    Global end of trial date
    09 Oct 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Oct 2019
    First version publication date
    24 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    64041757LUC2002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03371381
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202, Raritan, United States, NJ 08869
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Oct 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate whether the efficacy of JNJ-64041757 combined with nivolumab was better than the efficacy of nivolumab monotherapy for the subjects with mesothelin-positive relapsed/refractory Stage IIIB or Stage IV adenocarcinoma of the lung, by PD-L1 level.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety evaluations included monitoring of adverse events, clinical laboratory tests, symptom directed physical examinations, electrocardiograms (ECGs), vital signs, and ECOG performance status.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Mar 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    12
    EEA total number of subjects
    10
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    6
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 12 subjects were enrolled and treated in Phase 1b. No subject was enrolled in phase 2 of the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    JNJ-64041757+Nivolumab
    Arm description
    Subjects received nivolumab 240 milligram (mg) intravenous (IV) infusion followed by JNJ-64041757 (1*10^9 colony-forming units [CFUs]) IV infusion on Day 1 and nivolumab 240 mg IV infusion on Day 15 of each 28-day 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.
    Arm type
    Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    OPDIVO
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received IV infusions of nivolumab 240mg over approximately 60 minutes on Days 1 and 15 of each 28-day 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.

    Investigational medicinal product name
    JNJ-64041757
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous (IV) infusions of JNJ-64041757 (1*10^9 CFUs) over approximately 60 minutes on Day 1 of each 28-day 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.

    Number of subjects in period 1
    JNJ-64041757+Nivolumab
    Started
    12
    Completed
    0
    Not completed
    12
         Death
    5
         Study terminated by sponsor
    3
         Unspecified
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    JNJ-64041757+Nivolumab
    Reporting group description
    Subjects received nivolumab 240 milligram (mg) intravenous (IV) infusion followed by JNJ-64041757 (1*10^9 colony-forming units [CFUs]) IV infusion on Day 1 and nivolumab 240 mg IV infusion on Day 15 of each 28-day 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.

    Reporting group values
    JNJ-64041757+Nivolumab Total
    Number of subjects
    12 12
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    6 6
        From 65 to 84 years
    6 6
        85 years and over
    0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    61.2 ± 12.63 -
    Title for Gender
    Units: subjects
        Female
    4 4
        Male
    8 8

    End points

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    End points reporting groups
    Reporting group title
    JNJ-64041757+Nivolumab
    Reporting group description
    Subjects received nivolumab 240 milligram (mg) intravenous (IV) infusion followed by JNJ-64041757 (1*10^9 colony-forming units [CFUs]) IV infusion on Day 1 and nivolumab 240 mg IV infusion on Day 15 of each 28-day 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: Phase 1b: Percentage of Subjects with Objective Response

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    End point title
    Phase 1b: Percentage of Subjects with Objective Response [1]
    End point description
    Objective response rate is defined as the percentage of subjects who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). RECIST for CR - the disappearance of all lesions, all lymph nodes were non-pathological in size and normalization of tumor marker level; PR - greater than or equal to (>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions. The all treated analysis population consisted of subjects who received at least 1 dose of study agent.
    End point type
    Primary
    End point timeframe
    Up to 6.8 Months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    JNJ-64041757+Nivolumab
    Number of subjects analysed
    12
    Units: Percentage of Subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Phase 1b: Duration of Objective Response (DOR)

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    End point title
    Phase 1b: Duration of Objective Response (DOR)
    End point description
    DOR- the time from initial documentation of a response (CR or PR) to first documented date of disease progression (PD) or death from any cause. RECIST for PD - sum of diameters had increased by >= 20% and >=5 mm from nadir (including baseline if it was smallest sum). Subjects with measurable disease: for "unequivocal progression" based on non-target disease, there was an overall level of substantial worsening that merits discontinuation of therapy (if target disease is stable disease [SD]/PR). Subjects without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden must be comparable to increase required for PD of measurable disease. Furthermore, appearance of 1 or more new lesions or unequivocal progression of a non-target lesion. The all treated analysis population consisted of subjects who received at least 1 dose of study agent.
    End point type
    Secondary
    End point timeframe
    Up to 6.8 months
    End point values
    JNJ-64041757+Nivolumab
    Number of subjects analysed
    0 [2]
    Units: Hours
        number (not applicable)
    Notes
    [2] - Overall number of subjects analyzed is zero, since none of the subjects had objective response.
    No statistical analyses for this end point

    Secondary: Phase 1b: Number of Subjects with Progression-free Survival (PFS)

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    End point title
    Phase 1b: Number of Subjects with Progression-free Survival (PFS)
    End point description
    PFS - time from date of randomization until date of first documented evidence of PD (or relapse for subjects who experience CR during study) or death from any cause, whichever comes first. RECIST for PD - sum of diameters had increased by >= 20% and >=5 mm from nadir (including baseline if it was smallest sum). Subjects with measurable disease: for "unequivocal progression" based on non-target disease, there was an overall level of substantial worsening that merits discontinuation of therapy (if target disease is SD/PR). Subjects without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden must be comparable to increase required for PD of measurable disease. Furthermore, appearance of 1 or more new lesions or unequivocal progression of a non-target lesion. The all treated analysis population consisted of subjects who received at least 1 dose of study agent. Number of subjects with PFS event were reported.
    End point type
    Secondary
    End point timeframe
    Up to 6.8 months
    End point values
    JNJ-64041757+Nivolumab
    Number of subjects analysed
    12
    Units: Subjects
        number (not applicable)
    10
    No statistical analyses for this end point

    Secondary: Phase 1b: Number of Subjects with Overall Survival (OS)

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    End point title
    Phase 1b: Number of Subjects with Overall Survival (OS)
    End point description
    Overall Survival was defined as the duration from the date of randomization to the date of subject's death due to subjects with OS event (died) were reported.
    End point type
    Secondary
    End point timeframe
    Up to 6.8 months
    End point values
    JNJ-64041757+Nivolumab
    Number of subjects analysed
    12
    Units: Subjects
        number (not applicable)
    5
    No statistical analyses for this end point

    Secondary: Phase 1b: Number of Subjects with Treatment Emergent Adverse Events (TEAEs)

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    End point title
    Phase 1b: Number of Subjects with Treatment Emergent Adverse Events (TEAEs)
    End point description
    An adverse event is any untoward medical event that occurs in a subject administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as adverse events with onset or worsening on or after date of first dose of study treatment. Safety analysis set included subjects who received at least 1 administration of any study medication.
    End point type
    Secondary
    End point timeframe
    Up to 6.8 months
    End point values
    JNJ-64041757+Nivolumab
    Number of subjects analysed
    12
    Units: Subjects
    12
    No statistical analyses for this end point

    Secondary: Phase 1b: Number of Subjects With Positive Blood Culture

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    End point title
    Phase 1b: Number of Subjects With Positive Blood Culture
    End point description
    Number of subjects with surveillance cultures positive for listeriosis were reported. The all treated analysis population consisted of subjects who received at least 1 dose of study agent.
    End point type
    Secondary
    End point timeframe
    Up to 6.8 months
    End point values
    JNJ-64041757+Nivolumab
    Number of subjects analysed
    12
    Units: Subjects
    1
    No statistical analyses for this end point

    Secondary: Phase 1b: Number of Subjects with Bacterial Shedding

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    End point title
    Phase 1b: Number of Subjects with Bacterial Shedding
    End point description
    Number of subjects with bacterial shedding were reported. The shedding of JNJ-64041757 was studied in feces by stool or rectal swab, urine, and saliva. The all treated analysis population consisted of subjects who received at least 1 dose of study agent.
    End point type
    Secondary
    End point timeframe
    Up to 6.8 months
    End point values
    JNJ-64041757+Nivolumab
    Number of subjects analysed
    12
    Units: Subjects
    0
    No statistical analyses for this end point

    Secondary: Phase 1b: Serum Concentrations of Nivolumab

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    End point title
    Phase 1b: Serum Concentrations of Nivolumab
    End point description
    Nivolumab serum concentrations were reported. Pharmacokinetic (PK) population consisted of all subjects who received at least 1 dose of study agent and had one PK blood sample available. Early termination of study limited the evaluation of planned PK analysis.
    End point type
    Secondary
    End point timeframe
    Up to 6.8 months
    End point values
    JNJ-64041757+Nivolumab
    Number of subjects analysed
    0 [3]
    Units: Microgram per milliliter (mcg/mL)
        arithmetic mean (standard deviation)
    ±
    Notes
    [3] - Early termination of study limited the evaluation of planned PK analysis.
    No statistical analyses for this end point

    Secondary: Phase 1b: Number of Subjects With Anti-nivolumab Antibodies

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    End point title
    Phase 1b: Number of Subjects With Anti-nivolumab Antibodies
    End point description
    Number of subjects with antibodies to nivolumab were reported. The all treated analysis population consisted of subjects who received at least 1 dose of study agent.
    End point type
    Secondary
    End point timeframe
    Up to 6.8 months
    End point values
    JNJ-64041757+Nivolumab
    Number of subjects analysed
    12
    Units: Subjects
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 6.8 months
    Adverse event reporting additional description
    Safety analysis set included subjects who received at least 1 administration of any study medication.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    JNJ-64041757+Nivolumab
    Reporting group description
    Subjects received nivolumab 240 milligram (mg) intravenous (IV) infusion followed by JNJ-64041757 (1*10^9 colony-forming units [CFUs]) IV infusion on Day 1 and nivolumab 240 mg IV infusion on Day 15 of each 28-day 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.

    Serious adverse events
    JNJ-64041757+Nivolumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 12 (41.67%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    2 / 2
    Dyspnoea
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Non-Cardiac Chest Pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oedema Peripheral
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Back Pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    JNJ-64041757+Nivolumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 12 (100.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hypotension
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Inferior Vena Caval Occlusion
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    6 / 12 (50.00%)
         occurrences all number
    11
    Chills
         subjects affected / exposed
    7 / 12 (58.33%)
         occurrences all number
    14
    Fatigue
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Non-Cardiac Chest Pain
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Pyrexia
         subjects affected / exposed
    8 / 12 (66.67%)
         occurrences all number
    10
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Investigations
    Body Temperature Increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Blood Creatinine Increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Weight Decreased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Cardiac disorders
    Sinus Tachycardia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Tachycardia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 12 (41.67%)
         occurrences all number
    6
    Leukocytosis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    4
    Dyspnoea
         subjects affected / exposed
    5 / 12 (41.67%)
         occurrences all number
    6
    Haemoptysis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hypoxia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Pneumonitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Tremor
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Dry Mouth
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    5 / 12 (41.67%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    4
    Renal and urinary disorders
    Renal Failure
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatic Failure
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dry Skin
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Back Pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Joint Swelling
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Limb Discomfort
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Musculoskeletal Chest Pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Musculoskeletal Pain
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    5
    Pain in Extremity
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    4 / 12 (33.33%)
         occurrences all number
    7
    Hypomagnesaemia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hyponatraemia
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Respiratory Tract Infection
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jun 2017
    Protocol Amendment-1 included following changes: Added a phase 1b Run-in phase to assess the safety of the combination of JNJ-64041757 (JNJ-757) with nivolumab, clarified that the phase 2 randomization was limited to subjects with mesothelin-positive status at Screening, changed the stratification for randomization to 3 levels of programmed death receptor ligand-1, modified the assessment schedules for biomarkers, disease evaluation, blood cultures, nivolumab pharmacokinetics, and nivolumab immunogenicity, added measurements of patient-reported outcomes and updated the nivolumab dosing schedule and safety evaluations based on revisions to product labeling for nivolumab.
    04 Jan 2018
    Protocol Amendment-2 included following changes: Added mesothelin-positive status as an inclusion criterion for all subjects enrolled (phase 1b and phase 2) at Screening and modifications were made to the assessment schedules for biomarkers, core needle biopsy and to add biomarker measurements.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    21 Sep 2018
    The sponsor decided that based on no objective responses in all the 12 treated subjects in the study, along with the new safety concern of increased risk of pneumonitis, that the further development of JNJ-757 in combination with nivolumab would not be pursued. Because of this decision, the sponsor did not proceed to the Randomized phase 2 of the study or enroll any additional subjects in phase 1b, and the study was stopped early.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Sponsor did not proceed to Randomized phase 2 of study or enroll additional subjects in phase 1b as study was stopped early that resulted in limited evaluation of planned patient-related outcomes, PK, immunogenicity and biomarker analyses.
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