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    Clinical Trial Results:
    Safety and tolerability of neoadjuvant nivolumab for locally advanced resectable oral cancer, combined with [18F]BMS-986192 / [18F]-FDG PET imaging and immunomonitoring for response prediction.

    Summary
    EudraCT number
    		 2018-002643-28
    Trial protocol
    		 NL  
    Global end of trial date
    06 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Feb 2024
    First version publication date
    20 Feb 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CA209-8JD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BMS
    Sponsor organisation address
    Orteliuslaan 1000, Utrecht, Netherlands, 3258 BD
    Public contact
    Dr. C.W. Menke-van Houven van Oordt, Amsterdam UMC, locatie VUmc, 31 0204444321, c.menke@vumc.nl
    Scientific contact
    Dr. C.W. Menke-van Houven van Oordt, Amsterdam UMC, locatie VUmc, 31 0204444321, c.menke@vumc.nl
    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
    04 Feb 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To investigate heterogeneity in tumor uptake of [18F]BMS-986192 between patients and within tumor lesions of the same patient (primary tumor and TDLN/lymph node metastases) before treatment, in relation to changes in [18F]-FDG uptake before and on treatment 2. To investigate the feasibility and safety of neoadjuvant nivolumab immunotherapy prior to surgery for locally advanced oral cancer.
    Protection of trial subjects
    Yes
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 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
    Netherlands: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    3
    From 65 to 84 years
    12
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between March 1, 2019 and July 31, 2021 seventeen patients were enrolled. One patient had to be excluded from the study as the tumor was considered inoperable during the diagnostic workup.

    Pre-assignment
    Screening details
    		 During the screening period (day -5 – 0) potential subjects will be evaluated to determine that they fulfill the entry requirements as set forth in in- and exclusion criteria, according to protocol.

    Pre-assignment period milestones
    Number of subjects started
    		 16
    Number of subjects completed
    		 16

    Period 1
    Period 1 title
    Accrual (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All patients
    Arm description
    		 all patients
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    480 mg

    Number of subjects in period 1
    		All patients
    Started
    16
    Completed
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Accrual
    Reporting group description
    		 -

    Reporting group values
    		 Accrual Total
    Number of subjects
    		 16 16
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 70 ( 10 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 11 11
    Subject analysis sets

    Subject analysis set title
    NeoNivo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis

    Subject analysis sets values
    		 NeoNivo
    Number of subjects
    16
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    70 ( 10 )
    Gender categorical
    Units: Subjects
        Female
    5
        Male
    11

    End points

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    End points reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 all patients

    Subject analysis set title
    NeoNivo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis

    Primary: Serious adverse events

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    End point title
    		 Serious adverse events [1]
    End point description
    End point type
    Primary
    End point timeframe
    baseline - 100 days after nivolumab
    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: 6 SAEs were detected, no statistical analysis was performed on adverse events, only descriptive statistics were used.
    End point values
    		 NeoNivo
    Number of subjects analysed
    Units: SAE
        number (not applicable)
    6
    Attachments
    		 Untitled (Filename: 20240204_AEs.docx)
    No statistical analyses for this end point

    Secondary: [18F]BMS-986192 and [18F]-FDG SUVpeak in tumor lesions before and on-treatment

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    End point title
    		 [18F]BMS-986192 and [18F]-FDG SUVpeak in tumor lesions before and on-treatment
    End point description
    End point type
    Secondary
    End point timeframe
    baseline - follow-up scan
    End point values
    		 NeoNivo
    Number of subjects analysed
    15
    Units: SUVpeak
        median (inter-quartile range (Q1-Q3))
    5.2 (3.5 to 8.5)
    Attachments
    		 Imaging outcome
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Imaging I/Work-up till 100 days after nivolumab
    Adverse event reporting additional description
    Adverse events are defined as any undesirable experience occurring to a subject during the study, whether or not considered related to radioactive tracers or nivolumab treatment. All adverse events were evaluated by an investigator who is a qualified physician, according to the NCI CTCAE, version 5.0
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 16 (37.50%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    2
    Cardiac disorders
    Cardiac asthma
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Stroke
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Malnutrition
    Additional description: Hospitalisation due to malnutrition
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumoniae
    Additional description: Zie details in end point table
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 16 (100.00%)
    Cardiac disorders
    Edema limbs
    Additional description: 1 grade 2
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Atrial flutter
    Additional description: 1 grade 1
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Sinus bradycardia
    Additional description: 1 grade 1
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Supraventricular tachycardia
    Additional description: 1 grade 1
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Blood laboratory abnormality
    Additional description: 14 grade 1, 3 grade 2
         subjects affected / exposed
    16 / 16 (100.00%)
         occurrences all number
    16
    General disorders and administration site conditions
    Insomnia
    Additional description: 3 grade 1
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3
    Fatigue
    Additional description: 1 grade 1
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ear pain
    Additional description: 1 grade 1
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhea
    Additional description: 6 grade 1
         subjects affected / exposed
    6 / 16 (37.50%)
         occurrences all number
    6
    Constipation
    Additional description: 4 grade 1
         subjects affected / exposed
    4 / 16 (25.00%)
         occurrences all number
    4
    Vomiting
    Additional description: 1 grade 1, 2 grade 2
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Eczema
    Additional description: 2 grade 2
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Dermatitis
    Additional description: 1 grade 1
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Renal and urinary disorders
    Urine retention
    Additional description: 1 grade 2
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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