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    Clinical Trial Results:
    Phase I/II study of peptide vaccination associated with tumoral immunomodulation with proinflammatory cytokines and imiquimod in patients with advanced metastatic melanoma

    Summary
    EudraCT number
    		 2010-020435-40
    Trial protocol
    		 BE  
    Global end of trial date
    20 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Mar 2021
    First version publication date
    17 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LUC 10-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01191034
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cliniques universitaires Saint-Luc
    Sponsor organisation address
    Avenue Hippocrate 10, Brussels, Belgium, 1200
    Public contact
    Cliniques universitaires Saint-Luc, Cliniques universitaires Saint-Luc, 0032 2 7645471, jean-francois.baurain@uclouvain.be
    Scientific contact
    Jean-François Baurain, Jean-François Baurain, 0032 2 7645471, jean-francois.baurain@uclouvain.be
    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
    01 Aug 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Aug 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether peptide vaccination associated with local peritumoral treatment with a combination of interleukin-2, interferon-alpha, granulocyte-macrophage colony stimulating factor, and imiquimod, induces tumor responses.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) régulations/guidelines, and country-specific national and local laws.
    Background therapy
    		 - Vaccinations : vaccine MAGE-3.A1 peptide or NA17.A2 peptide - Local treatment with immunomodulatory drugs : IL-2, IFN-α, GM-CSF and Imiquimod
    Evidence for comparator
    		 No applicable
    Actual start date of recruitment
    01 Oct 2010
    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
    Belgium: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    1
    From 65 to 84 years
    1
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Dermatology consultation from AUG 2010 till MAR 2013

    Pre-assignment
    Screening details
    		 NA

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental arm
    Arm description
    		 The vaccine is either the MAGE-3.A1 peptide, or the NA17.A2 peptide, or both,matching the patient's HLA type and the gene expression of his tumor. If both antigens are expressed, then the patient received both peptides. This treatment is combine subcutaneous peritumoral injections of IL-2, IFN-α and GMCSF,as well as topical applications of imiquimod.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MAGE-3.A1 peptide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use, Intradermal use
    Dosage and administration details
    300 µg

    Investigational medicinal product name
    NA17.A2 peptide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use, Subcutaneous use
    Dosage and administration details
    300 µg

    Investigational medicinal product name
    IL-2
    Investigational medicinal product code
    Other name
    Proleukin®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IL-2 : 6000 IU peritumoral injection

    Investigational medicinal product name
    IFN-α
    Investigational medicinal product code
    Other name
    IntronA®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    IFN-α : 100.000 IU peritumoral injection

    Investigational medicinal product name
    GM-CSF
    Investigational medicinal product code
    Other name
    Leukine®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    GM-CSF : 300 ng peritumoral injection

    Investigational medicinal product name
    Imiquimod cream
    Investigational medicinal product code
    Other name
    Aldara
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    - Imiquimod cream : topical application, applied during 24h, applied on days +2 and +7 following vaccines 3 and 4.

    Number of subjects in period 1
    		Experimental arm
    Started
    3
    Completed
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 The vaccine is either the MAGE-3.A1 peptide, or the NA17.A2 peptide, or both,matching the patient's HLA type and the gene expression of his tumor. If both antigens are expressed, then the patient received both peptides. This treatment is combine subcutaneous peritumoral injections of IL-2, IFN-α and GMCSF, as well as topical applications of imiquimod.

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 3 3
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 1 1
        From 65-84 years
    		 1 1
        85 years and over
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 71 ( 13.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 The vaccine is either the MAGE-3.A1 peptide, or the NA17.A2 peptide, or both,matching the patient's HLA type and the gene expression of his tumor. If both antigens are expressed, then the patient received both peptides. This treatment is combine subcutaneous peritumoral injections of IL-2, IFN-α and GMCSF,as well as topical applications of imiquimod.

    Primary: Tumor response

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    End point title
    		 Tumor response [1]
    End point description
    To determine whether peptide vaccination associated with local peritumoral treatment with a combination of interleukin-2, interferon-alpha, granulocyte-macrophage colony stimulating factor, and imiquimod, induces tumor responses. Tumor response assessed in accordance with the Modified RECIST version 1.1
    End point type
    Primary
    End point timeframe
    Week 11 day 71
    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: only descriptive analysis since 3 patients included
    End point values
    		 Experimental arm
    Number of subjects analysed
    3
    Units: percent
        number (not applicable)
    66
    No statistical analyses for this end point

    Primary: Immunogenicity of the treatment

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    End point title
    		 Immunogenicity of the treatment [2]
    End point description
    To document whether this association induces cytolytic T lymphocyte responses to the vaccine antigens. CTL responses assessed by comparing either the anti-MAGE-3.A1 or the anti- NA17.A2 CTLp frequency in the pre- and post-immune blood of patients vaccinated with the respective antigen.
    End point type
    Primary
    End point timeframe
    At week 11, day 71
    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: only descriptive analysis since 3 patients included
    End point values
    		 Experimental arm
    Number of subjects analysed
    3
    Units: Immune response against Antigens
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Serious Adverse Events occurring at any time after the patient has signed the informed consent, the screening visit, and within 30 days of the last day on which the investigational agent was administered must be reported within 24 hours of awareness o
    Adverse event reporting additional description
    Adverse Events attributes assigned by the investigator: AE diagnosis or syndrome(s); event description; dates of onset and resolution; severity; assessment of relatedness to study treatment; and action taken.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE GRADE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 The vaccine is either the MAGE-3.A1 peptide, or the NA17.A2 peptide, or both,matching the patient's HLA type and the gene expression of his tumor. If both antigens are expressed, then the patient received both peptides. This treatment is combine subcutaneous peritumoral injections of IL-2, IFN-α and GMCSF,as well as topical applications of imiquimod.

    Serious adverse events
    		 Experimental arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Experimental arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
    Injury, poisoning and procedural complications
    Pain due to a fall
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Oedema right leg
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Pain right leg
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Bleeding of lesions after intratumoral infections
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Pain in injected lesions
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    2
    Gastrointestinal disorders
    Gastric pain
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Erythema right leg
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Dec 2010
    Amendment 1, version 1.1
    15 Mar 2012
    Amendment 2, version 2.0

    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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