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    Clinical Trial Results:
    Myeloid and plasmacytoid blood dendritic cells for immunotherapy of stage III melanoma patients

    Summary
    EudraCT number
    		 2010-023757-11
    Trial protocol
    		 NL  
    Global end of trial date
    14 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2022
    First version publication date
    29 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    myDC/pDC in stage III melanoma
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02574377
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    RadboudUMC
    Sponsor organisation address
    Geert Grooteplein Zuid, NIJMEGEN, Netherlands, 6525 GA
    Public contact
    Radboudumc, Radboud University Medical Centre Nijmegen, 0031 243617600, jolanda.devries@radboudumc.nl
    Scientific contact
    Radboudumc, Radboud University Medical Centre Nijmegen, 0031 243617600, jolanda.devries@radboudumc.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
    21 Apr 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is an interventional study and the primary objective is the biodistribution and the immunogenicity of single and combined pDC and myDC vaccination.
    Protection of trial subjects
    This study will be conducted in accordance with the principles of the Declaration of Helsinki (October 9th, 2004) and the Medical Research Involving Human Subjects Act (WMO; December 1st, 1999).All serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) will be reported via ToetsingOnline to the CCMO that approved the protocol, according to the requirements of the CCMO. All adverse events will be followed until they have abated, or until a stable situation has been reached. Depending on the event, follow up may require additional tests or medical procedures as indicated, and/or referral to the general physician or a medical specialist.
    Background therapy
    		 N.a.
    Evidence for comparator
    		 N.a.
    Actual start date of recruitment
    01 Oct 2015
    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: 17
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    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)
    12
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 17 patients were included in the study, of which 15 were evaluable. Two patients were replaced because of rapid disease progression.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 myDC
    Arm description
    		 Patients received myeloid dendritic cell vaccinations
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ex vivo labeled peptide-loaded blood DC product: myDC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intralymphatic use
    Dosage and administration details
    Vaccines consisted of 2-5 million autologous myDC

    Arm title
    		 p-DC
    Arm description
    		 Patients received plasmacytoid dendritic cell vaccinations
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ex vivo labeled peptide-loaded blood DC product: pDC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intralymphatic use
    Dosage and administration details
    Vaccines consisted of 1-3 million autologous pDC

    Arm title
    		 pDC/myDC
    Arm description
    		 Patients received combined plasmacytoid and myeloid dendritic cell vaccinations
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ex vivo labeled peptide-loaded blood DC product: myDC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intralymphatic use
    Dosage and administration details
    Vaccines consisted of 2-5 million autologous myDC

    Investigational medicinal product name
    Ex vivo labeled peptide-loaded blood DC product: pDC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intralymphatic use
    Dosage and administration details
    Vaccines consisted of 1-3 million autologous pDC

    Number of subjects in period 1
    		myDC p-DC pDC/myDC
    Started
    5
    7
    5
    Completed
    4
    3
    2
    Not completed
    1
    4
    3
         Consent withdrawn by subject
    -
    -
    1
         Disease progression
    1
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    myDC
    Reporting group description
    		 Patients received myeloid dendritic cell vaccinations

    Reporting group title
    p-DC
    Reporting group description
    		 Patients received plasmacytoid dendritic cell vaccinations

    Reporting group title
    pDC/myDC
    Reporting group description
    		 Patients received combined plasmacytoid and myeloid dendritic cell vaccinations

    Reporting group values
    		 myDC p-DC pDC/myDC Total
    Number of subjects
    		 5 7 5 17
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 4 4 4 12
        From 65-84 years
    		 1 3 1 5
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1 4 3 8
        Male
    		 4 3 2 9

    End points

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    End points reporting groups
    Reporting group title
    myDC
    Reporting group description
    		 Patients received myeloid dendritic cell vaccinations

    Reporting group title
    p-DC
    Reporting group description
    		 Patients received plasmacytoid dendritic cell vaccinations

    Reporting group title
    pDC/myDC
    Reporting group description
    		 Patients received combined plasmacytoid and myeloid dendritic cell vaccinations

    Subject analysis set title
    HLA-A2.1, HLA-AL or HLA-B35 positive patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients for whom matching MHC-dextramers were available to assess antigen-specificity of T-cells

    Subject analysis set title
    HLA-A2.1 positive patients with sufficient SKILS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients for whom both matching MHC-multimers were available and sufficient outgrowth of skin-infiltrating lymphocytes (SKILs) after DTH-challenge.

    Subject analysis set title
    Patients with sufficient SKILs regardless of HLA-haplotype
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients for whom sufficient SKILs were available to assess antigen-specificity of T-cells with an HLA-independent method

    Subject analysis set title
    Patients evaluable for HRQoL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients for whom an HRQoL questionnaire was completed at baseline and week 26

    Primary: Antigen-specific T-cells (in DTH-challenged sites) detected by MHC-multimer staining

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    End point title
    		 Antigen-specific T-cells (in DTH-challenged sites) detected by MHC-multimer staining [1]
    End point description
    Number of patients with demonstrable antigen-specific T-cells cultured from skin biopsies in a DTH-challenged site
    End point type
    Primary
    End point timeframe
    After the first vaccination cycle
    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: For this endpoint, no between-group comparison with statistical analysis was performed.
    End point values
    		 HLA-A2.1 positive patients with sufficient SKILS
    Number of subjects analysed
    5
    Units: Number of patients with a response
    4
    No statistical analyses for this end point

    Primary: Antigen-specific T-cells (in PBMCs) detected by MHC-multimer staining

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    End point title
    		 Antigen-specific T-cells (in PBMCs) detected by MHC-multimer staining [2]
    End point description
    Number of patients with demonstrable antigen-specific T-cells derived from PBMCs
    End point type
    Primary
    End point timeframe
    After the first vaccination cycle
    Notes
    [2] - 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: For this endpoint, no between-group comparison with statistical analysis was performed.
    End point values
    		 HLA-A2.1, HLA-AL or HLA-B35 positive patients
    Number of subjects analysed
    11
    Units: Patients with a response
    7
    No statistical analyses for this end point

    Primary: Antigen-specific T-cells (in DTH-challenged sites) assessed in an HLA-independent assay

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    End point title
    		 Antigen-specific T-cells (in DTH-challenged sites) assessed in an HLA-independent assay [3]
    End point description
    Number of patients with demonstrable antigen-specific T-cells cultured from skin biopsies in a DTH-challenged site, assessed by measuring IFNy - response after coculturing with peptide-loaded PBMCs.
    End point type
    Primary
    End point timeframe
    After the first vaccination cycle
    Notes
    [3] - 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: For this endpoint, no between-group comparison with statistical analysis was performed.
    End point values
    		 Patients with sufficient SKILs regardless of HLA-haplotype
    Number of subjects analysed
    14
    Units: Number of patients with a response
    9
    No statistical analyses for this end point

    Secondary: Recurrence-free survival

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    End point title
    		 Recurrence-free survival
    End point description
    Recurrence-free survival in months. For groups were median survival is not reached at the date of data-cutoff, the median duration of follow-up is given. This was the case for the pDC/myDC group.
    End point type
    Secondary
    End point timeframe
    Long-term follow-up
    End point values
    		 myDC p-DC pDC/myDC
    Number of subjects analysed
    5
    5
    5
    Units: months
        median (full range (min-max))
    17.1 (3.5 to 60.8)
    47.7 (9.2 to 61.5)
    57.5 (3.3 to 61.0)
    No statistical analyses for this end point

    Secondary: HRQoL - global health status

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    End point title
    		 HRQoL - global health status
    End point description
    As measured by EORTC-QLQ-C30 questionnaire
    End point type
    Secondary
    End point timeframe
    After 26 weeks compared to baseline
    End point values
    		 Patients evaluable for HRQoL
    Number of subjects analysed
    12
    Units: Difference in HRQoL score from baseline
        arithmetic mean (standard deviation)
    15 ( 16 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were reported from inclusion onwards throughout the treatment phase.
    Adverse event reporting additional description
    Adverse events of at least grade 3 or grade 1–2 and occurring in more than 1 patient are shown.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Serious adverse events
    		 Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 15 (100.00%)
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    5
    Blood and lymphatic system disorders
    Hypocalcaemia
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Hypophosphataemia
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    5
    Eosinophil count increased
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Hypernatraemia
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Hypokalaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    11 / 15 (73.33%)
         occurrences all number
    11
    Pain
    Additional description: Skin pain at administration site
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    4
    Injection site reaction
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Hepatobiliary disorders
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2

    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.
    Full article can be found on https://www.tandfonline.com/doi/full/10.1080/2162402X.2021.2015113

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30465182
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