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    Clinical Trial Results:
    An open Phase II study to assess the clinical activity and safety of recMAGE-A3 + AS15 cancer immunotherapeutic in patients with metastatic cutaneous melanoma, and to explore its immunogenic properties, including their relation to tumor infiltration, genomics and proteomics

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2008-001301-42
    Trial protocol
    FR   BE  
    Global end of trial date
    03 Nov 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Mar 2016
    First version publication date
    03 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    111473
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00896480
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.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
    06 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Clinical Activity - To characterize in patients with MAGE-A3-positive metastatic cutaneous melanoma: The clinical activity of the MAGE-A3 ASCI study treatment in terms of objective response (OR), stable disease (SD) and mixed response (MR)* The clinical activity of the MAGE-A3 ASCI study treatment in terms of time to treatment failure (TTF)* The safety of the MAGE-A3 ASCI study treatment. Immunogenicity - To document the humoral and cellular immune response induced by the MAGE-A3 ASCI study treatment.
    Protection of trial subjects
    The patients will be observed closely for at least 30 minutes following the administration of treatments, with appropriate medical treatment readily available in case of a rare anaphylactic reaction. VMAGE-A3 ASCI/placebo were administered by qualified and trained personnel, only to eligible subjects with no contraindications to any components of these products. During treatment, the following was checked to assess need to postpone treatment: acute disease at time of administration; any systemic grade ≥ 2 Common Terminology Criteria Adverse Event related or possibly related to treatment; fever, defined as an oral, axillary or tympanic temperature =< 38°C; need for influenza vaccine, immunoglobulins and/or any blood products; any medical reason exposing the patient to unacceptable risk. Patients were required to discontinue treatment in case of evidence of disease relapse/occurrence of second primary lung cancer; treatment with either investigational or non-registered product other than MAGE-A3 ASCI study product or other anticancer treatments; anaphylactic reaction following treatment administration; any intolerable adverse event; clinical signs or symptoms indicative of any autoimmune disorder, except vitiligo; appearance of any confirmed or suspected immunosuppressive or immunodeficient condition, or any condition requiring use of any immunosuppressive agent or systemic corticosteroids prescribed for chronic use; inability of the patient to complete study evaluations due to unforeseen circumstances; other conditions indicating the patient’s best interest to be withdrawn from treatment. In addition, between the end of the 120-weeks treatment phase, the following follow-up (FU) of patients was also planned: 1) an active FU for survival, recurrence, serious adverse events related to treatment & SAEs related to study participation and concurrent GSK medication of up to 5 years from the 1st treatment, and 2) annual contacts up to 10 years after 1st treatment.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 May 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    France: 15
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    11
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    During the screening the following steps occurred: check for inclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    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
    MAGE-A3 Group
    Arm description
    Patients planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    recMAGE-A3 recombinant protein formulated in AS15 adjuvant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Administration as follows: -Cycle 1 (ending Week 13): 6 doses at 2-week intervals (Weeks 1, 3, 5, 7, 9 and11) -Cycle 2 (ending Week 32): 6 doses at 3-week intervals (Weeks 15, 18, 21, 24, 27 and 30) -Cycle 3 (ending Week 54): 4 doses at 6-week intervals (Weeks 34, 40, 46 and 52) -Cycle 4: 4 doses at 12-week intervals, starting 12 weeks after end of Cycle 3, followed by, after an interruption of treatment of 6 months, 4 doses at 24-week intervals. All analyses were performed on the overall study population (MAGE3 Group) as well as in the subsets of patients with or without the pre-specified gene signature (GS+ or GS- groups) and in one patient with unknown status as regards GS signature (Unknown Group).

    Number of subjects in period 1
    MAGE-A3 Group
    Started
    24
    Completed
    0
    Not completed
    24
         Ongoing (unknown completion status)
    4
         Withdrawn
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MAGE-A3 Group
    Reporting group description
    Patients planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles.

    Reporting group values
    MAGE-A3 Group Total
    Number of subjects
    24 24
    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)
    65.4 ± 12.4 -
    Gender categorical
    Units: Subjects
        Female
    17 17
        Male
    7 7
    Subject analysis sets

    Subject analysis set title
    GS+/+ Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subset of patients with the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a gene signature positive for two biopsies, as assessed at screening.

    Subject analysis set title
    GS+/- Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subset of patients the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a gene signature positive for only one biopsies, as assessed at screening.

    Subject analysis set title
    GS- Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subset of patients the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a gene signature negative for both biopsies, as assessed at screening.

    Subject analysis sets values
    GS+/+ Group GS+/- Group GS- Group
    Number of subjects
    8
    8
    8
    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)
    70.1 ± 13.4
    66.3 ± 12.7
    59.9 ± 10.1
    Gender categorical
    Units: Subjects
        Female
    5
    5
    7
        Male
    3
    3
    1

    End points

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    End points reporting groups
    Reporting group title
    MAGE-A3 Group
    Reporting group description
    Patients planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles.

    Subject analysis set title
    GS+/+ Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subset of patients with the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a gene signature positive for two biopsies, as assessed at screening.

    Subject analysis set title
    GS+/- Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subset of patients the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a gene signature positive for only one biopsies, as assessed at screening.

    Subject analysis set title
    GS- Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subset of patients the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a gene signature negative for both biopsies, as assessed at screening.

    Primary: Percentage (%) of patients with mixed response (MxR) to MAGE-A3 ASCI study treatment

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    End point title
    Percentage (%) of patients with mixed response (MxR) to MAGE-A3 ASCI study treatment [1]
    End point description
    Assessment was done based on a set of MLs identified at baseline as TLs and NTLs (see above OR endpoint) followed up until disease progression. MLs were assessed as regards matching below MxR definitions. In case of evaluability per RECIST: a) MxR Type 1= at least (a.l.) 30% decrease in LD in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of TL and without appearance of one or more new lesions (= SD/PD with TL regression); b) MxR Type 2: appearance of one or more new lesions occurring in SD/PR status of LD of TL (= SD/PR with new lesion). In case of non-evaluability per RECIST (due to LD<20mm): a) MxR Type 1 = a clear decrease in diameters occurring in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of (baseline) TL and without appearance of one or more new lesions (= SD/PD with TL regression); b) MxR Type 2 = appearance of one or more new lesions occurring in SD/PR status of LD of TL (= SD/PR with new lesion).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at 1st report of disease progression in assessed lesions
    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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group GS+/+ Group GS+/- Group GS- Group
    Number of subjects analysed
    24
    8
    8
    8
    Units: Patients
        Best response CR
    2
    2
    0
    0
        Best response PR
    2
    1
    1
    0
        Best response MR (SD/PR)
    2
    1
    1
    0
        Best response MR (SD/PD)
    3
    2
    0
    1
        Best response SD
    1
    0
    0
    1
        Best response SD/PD
    0
    0
    0
    0
        Best response PD (SPD)
    4
    1
    1
    2
        Best response PD (SPD/MR)
    10
    1
    5
    4
        Best response NE
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage (%) of patients with best objective tumor response (OR) to MAGE-A3 ASCI study treatment

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    End point title
    Percentage (%) of patients with best objective tumor response (OR) to MAGE-A3 ASCI study treatment [2]
    End point description
    Response assessment was done based on a set of measurable lesions (MLs) identified at baseline as target lesions (TLs), and followed up until disease progression. Up to 5 MLs per organ & 10 MLs in total were identified as TLs and measured at baseline, selected based on size (those with the longest diameter [LD]) and measurability; a sum of LDs for all TLs was calculated and reported as baseline sum LD, which was used to characterize objective tumor response (OR), OR being defined as either complete response (CR) and/or partial response (PR) post MAGE-A3 ASCI treatment. All other lesions (or sites of disease) were to be identified as non-target lesions (NTL) and were to also be recorded and measured at baseline. After identification, MLs and TLs were assessed as regards CR and PR definitions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For RECIST criteria details, refer to Therasse P, et al., J Nat Cancer Inst 2000; 92: 205–216).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at 1st report of disease progression in assessed lesions
    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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group GS+/+ Group GS+/- Group GS- Group
    Number of subjects analysed
    24
    8
    8
    8
    Units: Patients
        Best response CR
    2
    2
    0
    0
        Best response PR
    2
    1
    1
    0
        Best response SD
    2
    0
    1
    1
        Best response SD/PR
    1
    1
    0
    0
        Best response PD
    17
    4
    6
    7
        Best response NE
    0
    0
    0
    0
        Best objective response Yes
    4
    3
    1
    0
        Best objective response No
    20
    5
    7
    8
        Disease Control Yes
    7
    4
    2
    1
        Disease Control No
    17
    4
    6
    7
    No statistical analyses for this end point

    Primary: Time to treatment failure (TTF), by Gene Signature

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    End point title
    Time to treatment failure (TTF), by Gene Signature [3]
    End point description
    TTF was defined as withdrawal from treatment with the MAGE-A3 ASCI study product due to disease progression or death. TTF analysis was performed using the non-parametric Kaplan-Meier method. “-9999” & “9999” as results when about the Unknown GS Group are placeholder values for confidence interval results being not applicable/missing.
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at 1st report of disease progression or death
    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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    GS+/+ Group GS+/- Group GS- Group
    Number of subjects analysed
    8
    8
    8
    Units: Time expressed in months
    median (confidence interval 95%)
        TTF
    14.8 (2.3 to 9999)
    2.3 (0.5 to 15)
    2.4 (0.5 to 4.6)
    No statistical analyses for this end point

    Primary: Number of seroconverted patients for anti-MAGE-A3

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    End point title
    Number of seroconverted patients for anti-MAGE-A3 [4]
    End point description
    Seroconversion was defined as a concentration of antibodies assessed that was greater than the cut-off value for a patient whose concentration of such antibodies was below the cut-off level before the initiation of treatment. Seroconverted patients were those patients with anti-MAGE-A3 antibody concentrations ≥ 27 EL.U/mL.
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at 1st report of disease progression in assessed lesions
    Notes
    [4] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group GS+/+ Group GS+/- Group GS- Group
    Number of subjects analysed
    18
    7
    5
    6
    Units: Patients
        Anti-MAGE-A3, PRE [N=18;7;5;6]
    3
    1
    1
    1
        Anti-MAGE-A3, PI (D2) [N=17;7;4;6]
    3
    1
    1
    1
        Anti-MAGE-A3, PI (D7) [N=18;7;5;6]
    4
    1
    2
    1
        Anti-MAGE-A3, PI (D15) [N=17;7;5;5]
    9
    3
    3
    3
        Anti-MAGE-A3, PII (D16) [N=15;7;3;5]
    8
    3
    2
    3
        Anti-MAGE-A3, PII (W5) [N=16;7;4;5]
    16
    7
    4
    5
        Anti-MAGE-A3, PV (W11) [N=12;4;4;4]
    12
    4
    4
    4
        Anti-MAGE-A3, PVI (W13) [N=16;7;4;5]
    16
    7
    4
    5
        Anti-MAGE-A3, PVIII (W21) [N=10;7;2;1]
    10
    7
    2
    1
        Anti-MAGE-A3, PXII (W32) [N=10;7;2;1]
    10
    7
    2
    1
        Anti-MAGE-A3, PXVI (W54) [N=5;4;1;0]
    5
    4
    1
    0
        Anti-MAGE-A3, PXVII (V21+3M) [N=3;3;0;0]
    3
    3
    0
    0
        Anti-MAGE-A3, PXVIII (V22+2W) [N=2;1;1;0]
    2
    1
    1
    0
        Anti-MAGE-A3, PXIX (V24+3M) [N=3;2;1;0]
    3
    2
    1
    0
        Anti-MAGE-A3, PXX (V25+2W) [N=3;2;1;0]
    3
    2
    1
    0
        Anti-MAGE-A3, PXX (V25+6M) [N=2;1;1;0]
    2
    1
    1
    0
        Anti-MAGE-A3, PXXI (V27+2W) [N=3;2;1;0]
    3
    2
    1
    0
        Anti-MAGE-A3, PXXI (V27+6M) [N=3;2;1;0]
    3
    2
    1
    0
        Anti-MAGE-A3, PXXII (V29+2W) [N=3;2;1;0]
    3
    2
    1
    0
        Anti-MAGE-A3, PXXIII (V31+2W) [N=2;2;0;0]
    2
    2
    0
    0
        Anti-MAGE-A3, CCL [N=5;2;0;3]
    5
    2
    0
    3
    No statistical analyses for this end point

    Primary: Anti-MAGE-A3 antibody concentrations

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    End point title
    Anti-MAGE-A3 antibody concentrations [5]
    End point description
    Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per millilitre (EL.U/mL). A seropositive patient was defined as a patient whose concentration greater than or equal to 27 EL.U/mL.
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at 1st report of disease progression in assessed lesions
    Notes
    [5] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group GS+/+ Group GS+/- Group GS- Group
    Number of subjects analysed
    18
    7
    5
    6
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-MAGE-A3, PRE [N=18;7;5;6]
    14.2 (9.5 to 21.4)
    13.9 (6.2 to 31.4)
    15.3 (4.7 to 49.9)
    13.8 (6.1 to 31.3)
        Anti-MAGE-A3, PI (D2) [N=17;7;4;6]
    14.6 (9.5 to 22.6)
    13.9 (6.2 to 30.8)
    16.8 (3.2 to 86.8)
    14.2 (5.8 to 34.7)
        Anti-MAGE-A3, PI (D7) [N=18;7;5;6]
    16.6 (11.1 to 24.7)
    16.1 (6.9 to 37.4)
    18.7 (5.9 to 59.2)
    15.5 (7.3 to 32.7)
        Anti-MAGE-A3, PI (D15) [N=17;7;5;5]
    56.6 (24.8 to 129)
    48.5 (11.6 to 202.6)
    72 (7.4 to 699.2)
    55.1 (5.9 to 512.2)
        Anti-MAGE-A3, PII (D16) [N=15;7;3;5]
    65.1 (25.5 to 166.6)
    55.4 (11.8 to 260.6)
    102.4 (0.7 to 15279.4)
    62.2 (5.8 to 662.9)
        Anti-MAGE-A3, PII (W5) [N=16;7;4;5]
    1865.7 (906.6 to 3839.3)
    1396.9 (234.5 to 8321.5)
    4120.2 (2093 to 8111)
    1484.1 (736.8 to 2989.6)
        Anti-MAGE-A3, PV (W11) [N=12;4;4;4]
    6312.1 (4177.9 to 9536.4)
    4161.6 (1542.3 to 11229.3)
    9775.9 (3065.3 to 31177.1)
    6181.6 (3414.2 to 11191.8)
        Anti-MAGE-A3, PVI (W13) [N=16;7;4;5]
    9080.5 (7030.9 to 11727.6)
    7797.4 (4564.5 to 13320.2)
    13789.3 (7278.1 to 26125.3)
    8046.1 (7249.1 to 8930.8)
        Anti-MAGE-A3, PVIII (W21) [N=10;7;2;1]
    8540.2 (5768.3 to 12644)
    7400.3 (4304 to 12724.1)
    12544.5 (371.2 to 423881.3)
    10790 (10790 to 10790)
        Anti-MAGE-A3, PXII (W32) [N=10;7;2;1]
    6826.9 (4728.9 to 9855.8)
    6128 (3601.6 to 10426.5)
    8384.1 (459.4 to 153006.6)
    9641 (9641 to 9641)
        Anti-MAGE-A3, PXVI (W54) [N=5;4;1;0]
    7429.9 (4876.9 to 11319.3)
    6542.6 (4660.3 to 9185.1)
    12357 (12357 to 12357)
    0 (0 to 0)
        Anti-MAGE-A3, PXVII (V21+3M) [N=3;3;0;0]
    3539.3 (2578.1 to 4859)
    3539.3 (2578.1 to 4859)
    0 (0 to 0)
    0 (0 to 0)
        Anti-MAGE-A3, PXVIII (V22+2W) [N=2;1;1;0]
    5972.3 (24 to 1485256)
    3869 (3869 to 3869)
    9219 (9219 to 9219)
    0 (0 to 0)
        Anti-MAGE-A3, PXIX (V24+3M) [N=3;2;1;0]
    5512.4 (1673 to 18163)
    4260 (452.7 to 40086)
    9230 (9230 to 9230)
    0 (0 to 0)
        Anti-MAGE-A3, PXX (V25+2W) [N=3;2;1;0]
    6523.7 (1713.7 to 24834.3)
    4804.1 (1467.6 to 15725.7)
    12030 (12030 to 12030)
    0 (0 to 0)
        Anti-MAGE-A3, PXX (V25+6M) [N=2;1;1;0]
    3429.1 (0.2 to 67399712)
    1575 (1575 to 1575)
    7466 (7466 to 7466)
    0 (0 to 0)
        Anti-MAGE-A3, PXXI (V27+2W) [N=3;2;1;0]
    5459.7 (1022.8 to 29145.2)
    3699.8 (2894.3 to 4729.5)
    11889 (11889 to 11889)
    0 (0 to 0)
        Anti-MAGE-A3, PXXI (V27+6M) [N=3;2;1;0]
    3010.6 (288.7 to 31395.3)
    1754.4 (351.7 to 8751.9)
    8865 (8865 to 8865)
    0 (0 to 0)
        Anti-MAGE-A3, PXXII (V29+2W) [N=3;2;1;0]
    4657.1 (529.4 to 40967)
    3077.8 (5.3 to 1801276)
    10663 (10663 to 10663)
    0 (0 to 0)
        Anti-MAGE-A3, PXXIII (V31+2W) [N=2;2;0;0]
    2248.7 (226.4 to 22332.9)
    2248.7 (226.4 to 22332.9)
    0 (0 to 0)
    0 (0 to 0)
        Anti-MAGE-A3, CCL [N=5;2;0;3]
    6972.9 (2571.8 to 18905.3)
    4057.1 (0.1 to 135760000)
    0 (0 to 0)
    10004.8 (4092.9 to 24455.9)
    No statistical analyses for this end point

    Primary: Number of patients with treatment response for anti-MAGE-A3 antibodies

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    End point title
    Number of patients with treatment response for anti-MAGE-A3 antibodies [6]
    End point description
    For initially seronegative patients: post-administration antibody concentration ≥ 27 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration
    End point type
    Primary
    End point timeframe
    From Dose 2 to Study End
    Notes
    [6] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group GS+/+ Group GS+/- Group GS- Group
    Number of subjects analysed
    18
    7
    5
    6
    Units: Patients
        Anti-MAGE-A3, PI (D2) [N=17;7;4;6]
    0
    0
    0
    0
        Anti-MAGE-A3, PI (D7) [N=18;7;5;6]
    1
    0
    1
    0
        Anti-MAGE-A3, PI (D15) [N=17;7;5;5]
    9
    3
    3
    3
        Anti-MAGE-A3, PII (D16) [N=15;7;3;5]
    8
    3
    2
    3
        Anti-MAGE-A3, PII (W5) [N=16;7;4;5]
    16
    7
    4
    5
        Anti-MAGE-A3, PV (W11) [N=12;4;4;4]
    12
    4
    4
    4
        Anti-MAGE-A3, PVI (W13) [N=16;7;4;5]
    16
    7
    4
    5
        Anti-MAGE-A3, PVIII (W21) [N=10;7;2;1]
    10
    7
    2
    1
        Anti-MAGE-A3, PXII (W32) [N=10;7;2;1]
    10
    7
    2
    1
        Anti-MAGE-A3, PXVI (W54) [N=5;4;1;0]
    5
    4
    1
    0
        Anti-MAGE-A3, PXVII (V21+3M) [N=3;3;0;0]
    3
    3
    0
    0
        Anti-MAGE-A3, PXVIII (V22+2W) [N=2;1;1;0]
    2
    1
    1
    0
        Anti-MAGE-A3, PXIX (V24+3M) [N=3;2;1;0]
    3
    2
    1
    0
        Anti-MAGE-A3, PXX (V25+2W) [N=3;2;1;0]
    3
    2
    1
    0
        Anti-MAGE-A3, PXX (V25+6M) [N=2;1;1;0]
    2
    1
    1
    0
        Anti-MAGE-A3, PXXI (V27+2W) [N=3;2;1;0]
    3
    2
    1
    0
        Anti-MAGE-A3, PXXI (V27+6M) [N=3;2;1;0]
    3
    2
    1
    0
        Anti-MAGE-A3, PXXII (V29+2W) [N=3;2;1;0]
    3
    2
    1
    0
        Anti-MAGE-A3, PXXIII (V31+2W) [N=2;2;0;0]
    2
    2
    0
    0
        Anti-MAGE-A3, CCL [N=5;2;0;3]
    5
    2
    0
    3
    No statistical analyses for this end point

    Primary: mean of Anti-MAGE-A3 specific CD4+ and CD8+ T-cells concentrations after immunization

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    End point title
    mean of Anti-MAGE-A3 specific CD4+ and CD8+ T-cells concentrations after immunization [7]
    End point description
    A patient was considered as a cellular mediated immune (CMI) responder if there was an increased amount of antigen-specific T-cells after immunization as compared to the patient’s baseline value. These specific T-cells included the CD4+ or CD8+ T-cells producing cytokines and/or presenting cytolytic activity (or other, following the updated method of detection), and/or specific CD4+ or CD8+ T-cells presenting a particular phenotype (effector/memory).
    End point type
    Primary
    End point timeframe
    From study start to study end
    Notes
    [7] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    17
    Units: T cell
    geometric mean (confidence interval 95%)
        CD4.TNFα (+) + IFNγ (+) PRE
    1.05 (0.98 to 1.11)
        CD8.TNFα (+) + IFNγ (+) PRE
    1.01 (0.99 to 1.03)
        CD4.TNFα (+) + IFNγ (+) PII(W5)
    3.36 (2.2 to 5.13)
        CD8.TNFα (+) + IFNγ (+) PII(W5)
    1 (1 to 1)
        CD4.TNFα (+) + IFNγ (+) PVI(W13)
    5.35 (2.42 to 11.79)
        CD8.TNFα (+) + IFNγ (+) PVI(W13)
    1 (1 to 1)
        CD4.TNFα (+) + IFNγ (+) PXII(W32)
    5.29 (2.09 to 13.37)
        CD8.TNFα (+) + IFNγ (+) PXII(W32)
    1.04 (0.99 to 1.09)
        CD4.TNFα (+) + IFNγ (+) PXVI(W54)
    2.83 (1.04 to 7.68)
        CD8.TNFα (+) + IFNγ (+) PXVI(W54)
    1 (1 to 1)
        CD4.TNFα (+) + IFNγ (+) PXVIII(V22+2W)
    2.62 (0.07 to 92.58)
        CD8.TNFα (+) + IFNγ (+) PXVIII(V22+2W)
    1 (1 to 1)
        CD4.TNFα (+) + IFNγ (+) PXX(V25+2W)
    2.13 (0.29 to 15.91)
        CD8.TNFα (+) + IFNγ (+) PXX(V25+2W)
    1.05 (0.86 to 1.28)
        CD4.TNFα (+) + IFNγ (+) CCL
    2.42 (0 to 185163.6)
        CD8.TNFα (+) + IFNγ (+) CCL
    1 (1 to 1)
        CD4.TNFα (+) + IFNγ (+) At any time point
    0 (0 to 0)
        CD8.TNFα (+) + IFNγ (+) At any time point
    0 (0 to 0)
    No statistical analyses for this end point

    Primary: CD4+ and CD8+ T cell frequency ≥ 1.24 cut-off

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    End point title
    CD4+ and CD8+ T cell frequency ≥ 1.24 cut-off [8]
    End point description
    A patient was considered as a cellular mediated immune (CMI) responder if there was an increased amount of antigen-specific T-cells after immunization as compared to the patient’s baseline value. These specific T-cells included the CD4+ or CD8+ T-cells producing cytokines and/or presenting cytolytic activity (or other, following the updated method of detection), and/or specific CD4+ or CD8+ T-cells presenting a particular phenotype (effector/memory).
    End point type
    Primary
    End point timeframe
    From study start to study end
    Notes
    [8] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    17
    Units: Patients
        CD4.TNFα (+) + IFNγ (+) PRE
    1
        CD8.TNFα (+) + IFNγ (+) PRE
    1
        CD4.TNFα (+) + IFNγ (+) PII(W5)
    15
        CD8.TNFα (+) + IFNγ (+) PII(W5)
    0
        CD4.TNFα (+) + IFNγ (+) PVI(W13)
    11
        CD8.TNFα (+) + IFNγ (+) PVI(W13)
    0
        CD4.TNFα (+) + IFNγ (+) PXII(W32)
    9
        CD8.TNFα (+) + IFNγ (+) PXII(W32)
    2
        CD4.TNFα (+) + IFNγ (+) PXVI(W54)
    4
        CD8.TNFα (+) + IFNγ (+) PXVI(W54)
    0
        CD4.TNFα (+) + IFNγ (+) PXVIII(V22+2W)
    2
        CD8.TNFα (+) + IFNγ (+) PXVIII(V22+2W)
    0
        CD4.TNFα (+) + IFNγ (+) PXX(V25+2W)
    2
        CD8.TNFα (+) + IFNγ (+) PXX(V25+2W)
    1
        CD4.TNFα (+) + IFNγ (+) CCL
    1
        CD8.TNFα (+) + IFNγ (+) CCL
    0
        CD4.TNFα (+) + IFNγ (+) At any time point
    15
        CD8.TNFα (+) + IFNγ (+) At any time point
    3
    No statistical analyses for this end point

    Primary: Number of patients with a cellular response (Anti-MAGE-A3 specific CD4+ and CD8+ T-cells concentrations after immunization)

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    End point title
    Number of patients with a cellular response (Anti-MAGE-A3 specific CD4+ and CD8+ T-cells concentrations after immunization) [9]
    End point description
    A patient was considered as a cellular mediated immune (CMI) responder if there was an increased amount of antigen-specific T-cells after immunization as compared to the patient’s baseline value. These specific T-cells included the CD4+ or CD8+ T-cells producing cytokines and/or presenting cytolytic activity (or other, following the updated method of detection), and/or specific CD4+ or CD8+ T-cells presenting a particular phenotype (effector/memory). Analysis of MAGE-A3 cellular response was not performed. So the numbers presented for them are placeholder values.
    End point type
    Primary
    End point timeframe
    From week 5 to study end
    Notes
    [9] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    17
    Units: Patients
        CD4.TNFα (+) + IFNγ (+) PII(W5)
    5
        CD8.TNFα (+) + IFNγ (+) PII(W5)
    0
        CD4.TNFα (+) + IFNγ (+) PVI(W13)
    8
        CD8.TNFα (+) + IFNγ (+) PVI(W13)
    0
        CD4.TNFα (+) + IFNγ (+) PXII(W32)
    4
        CD8.TNFα (+) + IFNγ (+) PXII(W32)
    0
        CD4.TNFα (+) + IFNγ (+) PXVI(W54)
    2
        CD8.TNFα (+) + IFNγ (+) PXVI(W54)
    0
        CD4.TNFα (+) + IFNγ (+) PXVIII(V22+2W)
    0
        CD8.TNFα (+) + IFNγ (+) PXVIII(V22+2W)
    0
        CD4.TNFα (+) + IFNγ (+) PXX(V25+2W)
    1
        CD8.TNFα (+) + IFNγ (+) PXX(V25+2W)
    0
        CD4.TNFα (+) + IFNγ (+) CCL
    1
        CD8.TNFα (+) + IFNγ (+) CCL
    0
        CD4.TNFα (+) + IFNγ (+) At any time point
    12
        CD8.TNFα (+) + IFNγ (+) At any time point
    0
    No statistical analyses for this end point

    Primary: Number of patients reported with ASCI-related grade3/4 adverse events (AEs) according to the Common Terminology Criteria (CTCAE) version 3.0.

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    End point title
    Number of patients reported with ASCI-related grade3/4 adverse events (AEs) according to the Common Terminology Criteria (CTCAE) version 3.0. [10]
    End point description
    The assessed AEs were ASCI-related grade 3/4 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. AEs may include pre- or post-treatment events that occur as a result of protocol-mandated procedures (i.e. invasive procedures, modification of patient’s previous therapeutic regimen). Related = AE assessed by the investigator as related to the treatment.
    End point type
    Primary
    End point timeframe
    Within the 31-day (Days 0-30) post-administration periods.
    Notes
    [10] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        Any event, Grade 3
    0
        Any event, Grade 4
    0
    No statistical analyses for this end point

    Primary: Number of patients reported with serious adverse events (SAEs)

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    End point title
    Number of patients reported with serious adverse events (SAEs) [11]
    End point description
    Serious adverse events (SAEs) include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient, is a Grade 4 AE according to the CTCAE, version3.0. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. However, if the investigator considered that there was a causal relationship between treatment or protocol design/procedures and the disease progression/recurrence, then the event was reported as an SAE. Any new primary cancer (non-related to the cancer under study) was reported as an SAE.
    End point type
    Primary
    End point timeframe
    During the entire study period.
    Notes
    [11] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        Any SAEs
    2
    No statistical analyses for this end point

    Primary: Number of patients with abnormal Alanine aminotransferase (ALT) values by maximum grade

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    End point title
    Number of patients with abnormal Alanine aminotransferase (ALT) values by maximum grade [12]
    End point description
    The status of each patient as regards ALT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [12] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        ALT - SCR G0; SE G0
    20
        ALT - SCR G0; SE G1
    3
        ALT - SCR G0; SE G2
    0
        ALT - SCR G0; SE G3
    1
        ALT - SCR G0; SE G4
    0
        ALT - SCR G0; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal Aspartate aminotransferase (AST) values by maximum grade

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    End point title
    Number of patients with abnormal Aspartate aminotransferase (AST) values by maximum grade [13]
    End point description
    The status of each patient as regards AST laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported was Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [13] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        AST - SCR G0; SE G0
    19
        AST - SCR G0; SE G1
    5
        AST - SCR G0; SE G2
    0
        AST - SCR G0; SE G3
    0
        AST - SCR G0; SE G4
    0
        AST - SCR G0; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal Alkaline Phosphatase (ALK) values by maximum grade

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    End point title
    Number of patients with abnormal Alkaline Phosphatase (ALK) values by maximum grade [14]
    End point description
    The status of each patient as regards ALK laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK) and Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [14] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        ALK - SCR UNK; SE G0
    0
        ALK - SCR UNK; SE G1
    0
        ALK - SCR UNK; SE G2
    0
        ALK - SCR UNK; SE G3
    0
        ALK - SCR UNK; SE G4
    0
        ALK - SCR UNK; SE UNK
    1
        ALK - SCR G0; SE G0
    17
        ALK - SCR G0; SE G1
    6
        ALK - SCR G0; SE G2
    0
        ALK - SCR G0; SE G3
    0
        ALK - SCR G0; SE G4
    0
        ALK - SCR G0; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal Bilirubine (BIL) values by maximum grade

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    End point title
    Number of patients with abnormal Bilirubine (BIL) values by maximum grade [15]
    End point description
    The status of each patient as regards BIL laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported was Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [15] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        BIL - SCR G0; SE G0
    24
        BIL - SCR G0; SE G1
    0
        BIL - SCR G0; SE G2
    0
        BIL - SCR G0; SE G3
    0
        BIL - SCR G0; SE G4
    0
        BIL - SCR G0; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal Creatinine (CREA) values by maximum grade

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    End point title
    Number of patients with abnormal Creatinine (CREA) values by maximum grade [16]
    End point description
    The status of each patient as regards CREA laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [16] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        CREA - SCR G0; SE G0
    20
        CREA - SCR G0; SE G1
    2
        CREA - SCR G0; SE G2
    0
        CREA - SCR G0; SE G3
    0
        CREA - SCR G0; SE G4
    0
        CREA - SCR G0; SE UNK
    1
        CREA - SCR G1; SE G0
    0
        CREA - SCR G1; SE G1
    0
        CREA - SCR G1; SE G2
    1
        CREA - SCR G1; SE G3
    0
        CREA - SCR G1; SE UNK
    0
        CREA - SCR G1; SE G4
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal gamma-glutamyl transpeptidase (GGT) values by maximum grade

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    End point title
    Number of patients with abnormal gamma-glutamyl transpeptidase (GGT) values by maximum grade [17]
    End point description
    The status of each patient as regards GGT laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK) Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [17] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        GGT - SCR UNK; SE G0
    0
        GGT - SCR UNK; SE G1
    1
        GGT - SCR UNK; SE G2
    0
        GGT - SCR UNK; SE G3
    0
        GGT - SCR UNK; SE G4
    0
        GGT - SCR UNK; SE UNK
    0
        GGT - SCR G0; SE G0
    17
        GGT - SCR G0; SE G1
    2
        GGT - SCR G0; SE G2
    1
        GGT - SCR G0; SE G3
    0
        GGT - SCR G0; SE G4
    0
        GGT - SCR G0; SE UNK
    0
        GGT - SCR G1; SE G0
    0
        GGT - SCR G1; SE G1
    2
        GGT - SCR G1; SE G2
    0
        GGT - SCR G1; SE G3
    1
        GGT - SCR G1; SE G4
    0
        GGT - SCR G1; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal Hemoglobin (HGB) values by maximum grade

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    End point title
    Number of patients with abnormal Hemoglobin (HGB) values by maximum grade [18]
    End point description
    The status of each patient as regards HGB laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [18] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        HGB - SCR G0; SE G0
    14
        HGB - SCR G0; SE G1
    9
        HGB - SCR G0; SE G2
    0
        HGB - SCR G0; SE G3
    0
        HGB - SCR G0; SE G4
    0
        HGB - SCR G0; SE UNK
    0
        HGB - SCR G1; SE G0
    0
        HGB - SCR G1; SE G1
    1
        HGB - SCR G1; SE G2
    0
        HGB - SCR G1; SE G3
    0
        HGB - SCR G1; SE G4
    0
        HGB - SCR G1; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal Hypercalcemia (HCA) values by maximum grade

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    End point title
    Number of patients with abnormal Hypercalcemia (HCA) values by maximum grade [19]
    End point description
    The status of each patient as regards HCA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [19] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        HCA - SCR UNK; SE G0
    3
        HCA - SCR UNK; SE G1
    0
        HCA - SCR UNK; SE G2
    0
        HCA - SCR UNK; SE G3
    0
        HCA - SCR UNK; SE G4
    0
        HCA - SCR UNK; SE UNK
    0
        HCA - SCR G0; SE G0
    15
        HCA - SCR G0; SE G1
    3
        HCA - SCR G0; SE G2
    0
        HCA - SCR G0; SE G3
    0
        HCA - SCR G0; SE G4
    0
        HCA - SCR G0; SE UNK
    0
        HCA - SCR G1; SE G0
    1
        HCA - SCR G1; SE G1
    2
        HCA - SCR G1; SE G2
    0
        HCA - SCR G1; SE G3
    0
        HCA - SCR G1; SE G4
    0
        HCA - SCR G1; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal Hyperkalemia (HKA) values by maximum grade

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    End point title
    Number of patients with abnormal Hyperkalemia (HKA) values by maximum grade [20]
    End point description
    The status of each patient as regards HKA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [20] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        HKA - SCR UNK; SE G0
    2
        HKA - SCR UNK; SE G1
    0
        HKA - SCR UNK; SE G2
    0
        HKA - SCR UNK; SE G3
    0
        HKA - SCR UNK; SE G4
    0
        HKA - SCR UNK; SE UNK
    0
        HKA - SCR G0; SE G0
    17
        HKA - SCR G0; SE G1
    3
        HKA - SCR G0; SE G2
    1
        HKA - SCR G0; SE G3
    0
        HKA - SCR G0; SE G4
    0
        HKA - SCR G0; SE UNK
    0
        HKA - SCR G1; SE G0
    0
        HKA - SCR G1; SE G1
    0
        HKA - SCR G1; SE G2
    1
        HKA - SCR G1; SE G3
    0
        HKA - SCR G1; SE G4
    0
        HKA - SCR G1; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal Hypernatremia (HNA) values by maximum grade

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    End point title
    Number of patients with abnormal Hypernatremia (HNA) values by maximum grade [21]
    End point description
    The status of each patient as regards HNA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK) and Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [21] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        HNA - SCR UNK; SE G0
    2
        HNA - SCR UNK; SE G1
    0
        HNA - SCR UNK; SE G2
    0
        HNA - SCR UNK; SE G3
    0
        HNA - SCR UNK; SE G4
    0
        HNA - SCR UNK; SE UNK
    0
        HNA - SCR G0; SE G0
    19
        HNA - SCR G0; SE G1
    3
        HNA - SCR G0; SE G2
    0
        HNA - SCR G0; SE G3
    0
        HNA - SCR G0; SE G4
    0
        HNA - SCR G0; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal hypoalbuminemia(hAL) values by maximum grade

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    End point title
    Number of patients with abnormal hypoalbuminemia(hAL) values by maximum grade [22]
    End point description
    The status of each patient as regards hAL laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK) and Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [22] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        hAL - SCR UNK; SE G0
    1
        hAL - SCR UNK; SE G1
    1
        hAL - SCR UNK; SE G2
    0
        hAL - SCR UNK; SE G3
    0
        hAL - SCR UNK; SE G4
    0
        hAL - SCR UNK; SE UNK
    0
        hAL - SCR G0; SE G0
    21
        hAL - SCR G0; SE G1
    0
        hAL - SCR G0; SE G2
    0
        hAL - SCR G0; SE G3
    0
        hAL - SCR G0; SE G4
    0
        hAL - SCR G0; SE UNK
    1
    No statistical analyses for this end point

    Primary: Number of patients with abnormal hypocalcemia(hCA) values by maximum grade

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    End point title
    Number of patients with abnormal hypocalcemia(hCA) values by maximum grade [23]
    End point description
    The status of each patient as regards hCA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [23] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        hCA - SCR UNK; SE G0
    3
        hCA - SCR UNK; SE G1
    0
        hCA - SCR UNK; SE G2
    0
        hCA - SCR UNK; SE G3
    0
        hCA - SCR UNK; SE G4
    0
        hCA - SCR UNK; SE UNK
    0
        hCA - SCR G0; SE G0
    18
        hCA - SCR G0; SE G1
    2
        hCA - SCR G0; SE G2
    0
        hCA - SCR G0; SE G3
    0
        hCA - SCR G0; SE G4
    0
        hCA - SCR G0; SE UNK
    0
        hCA - SCR G1; SE G0
    0
        hCA - SCR G1; SE G1
    1
        hCA - SCR G1; SE G2
    0
        hCA - SCR G1; SE G3
    0
        hCA - SCR G1; SE G4
    0
        hCA - SCR G1; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal hypokalemia (hKA) values by maximum grade

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    End point title
    Number of patients with abnormal hypokalemia (hKA) values by maximum grade [24]
    End point description
    The status of each patient as regards hKA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK) and Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [24] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        hKA - SCR UNK; SE G0
    2
        hKA - SCR UNK; SE G1
    0
        hKA - SCR UNK; SE G2
    0
        hKA - SCR UNK; SE G3
    0
        hKA - SCR UNK; SE G4
    0
        hKA - SCR UNK; SE UNK
    0
        hKA - SCR G0; SE G0
    19
        hKA - SCR G0; SE G1
    3
        hKA - SCR G0; SE G2
    0
        hKA - SCR G0; SE G3
    0
        hKA - SCR G0; SE G4
    0
        hKA - SCR G0; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal hyponatremia (hNA) values by maximum grade

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    End point title
    Number of patients with abnormal hyponatremia (hNA) values by maximum grade [25]
    End point description
    The status of each patient as regards hNA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK) and Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [25] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        hNA - SCR UNK; SE G0
    2
        hNA - SCR UNK; SE G1
    0
        hNA - SCR UNK; SE G2
    0
        hNA - SCR UNK; SE G3
    0
        hNA - SCR UNK; SE G4
    0
        hNA - SCR UNK; SE UNK
    0
        hNA - SCR G0; SE G0
    18
        hNA - SCR G0; SE G1
    4
        hNA - SCR G0; SE G2
    0
        hNA - SCR G0; SE G3
    0
        hNA - SCR G0; SE G4
    0
        hNA - SCR G0; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal Leukocytes (LEU) values by maximum grade

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    End point title
    Number of patients with abnormal Leukocytes (LEU) values by maximum grade [26]
    End point description
    The status of each patient as regards LEU laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [26] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        LEU - SCR G0; SE G0
    21
        LEU - SCR G0; SE G1
    2
        LEU - SCR G0; SE G2
    0
        LEU - SCR G0; SE G3
    0
        LEU - SCR G0; SE G4
    0
        LEU - SCR G0; SE UNK
    0
        LEU - SCR G1; SE G0
    1
        LEU - SCR G1; SE G1
    0
        LEU - SCR G1; SE G2
    0
        LEU - SCR G1; SE G3
    0
        LEU - SCR G1; SE G4
    0
        LEU - SCR G1; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal Lymphopenia (LYM) values by maximum grade

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    End point title
    Number of patients with abnormal Lymphopenia (LYM) values by maximum grade [27]
    End point description
    The status of each patient as regards LYM laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [27] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        LYM - SCR G0; SE G0
    17
        LYM - SCR G0; SE G1
    0
        LYM - SCR G0; SE G2
    3
        LYM - SCR G0; SE G3
    0
        LYM - SCR G0; SE G4
    0
        LYM - SCR G0; SE UNK
    0
        LYM - SCR G1; SE G0
    1
        LYM - SCR G1; SE G1
    3
        LYM - SCR G1; SE G2
    0
        LYM - SCR G1; SE G3
    0
        LYM - SCR G1; SE G4
    0
        LYM - SCR G1; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal Neutrophils (NEU) values by maximum grade

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    End point title
    Number of patients with abnormal Neutrophils (NEU) values by maximum grade [28]
    End point description
    The status of each patient as regards NEU laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported was Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [28] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        NEU - SCR G0; SE G0
    21
        NEU - SCR G0; SE G1
    2
        NEU - SCR G0; SE G2
    1
        NEU - SCR G0; SE G3
    0
        NEU - SCR G0; SE G4
    0
        NEU - SCR G0; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with abnormal Platelets(PLT) values by maximum grade

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    End point title
    Number of patients with abnormal Platelets(PLT) values by maximum grade [29]
    End point description
    The status of each patient as regards PLT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported was Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Primary
    End point timeframe
    From study start to study end, each patient being censored out of the analysis at time of death.
    Notes
    [29] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        PLT - SCR G0; SE G0
    24
        PLT - SCR G0; SE G1
    0
        PLT - SCR G0; SE G2
    0
        PLT - SCR G0; SE G3
    0
        PLT - SCR G0; SE G4
    0
        PLT - SCR G0; SE UNK
    0
    No statistical analyses for this end point

    Primary: Number of patients with any AE(s) and with AEs by maximum grade, related to treatment administration

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    End point title
    Number of patients with any AE(s) and with AEs by maximum grade, related to treatment administration [30]
    End point description
    An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5.
    End point type
    Primary
    End point timeframe
    Within the 31-day follow-up period post treatment administration.
    Notes
    [30] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        Patients with any AEs
    23
        Patients with G1 AEs
    11
        Patients with G2 AEs
    12
        Patients with G3 AEs
    0
        Patients with G4 AEs
    0
        Patients with G5 AEs
    0
    No statistical analyses for this end point

    Primary: Number of patients with any adverse events (AEs) and with AEs by maximum grade

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    End point title
    Number of patients with any adverse events (AEs) and with AEs by maximum grade [31]
    End point description
    An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5.
    End point type
    Primary
    End point timeframe
    Within the 31-day follow-up period post treatment administration.
    Notes
    [31] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        Patients with any AEs
    24
        Patients with G1 AEs
    6
        Patients with G2 AEs
    15
        Patients with G3 AEs
    0
        Patients with G4 AEs
    0
        Patients with G5 AEs
    0
    No statistical analyses for this end point

    Primary: Number of patients with any serious adverse events (SAEs) and with AEs by maximum grade

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    End point title
    Number of patients with any serious adverse events (SAEs) and with AEs by maximum grade [32]
    End point description
    SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient, is a Grade 4 AE according to the CTCAE, version3.0. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. SAEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5.
    End point type
    Primary
    End point timeframe
    Within the 31-day follow-up period post treatment administration.
    Notes
    [32] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        Patients with any SAEs
    2
        Patients with G1 SAEs
    0
        Patients with G2 SAEs
    1
        Patients with G3 SAEs
    1
        Patients with G4 SAEs
    0
        Patients with G5 SAEs
    0
    No statistical analyses for this end point

    Primary: Number of patients with any serious adverse events (SAEs) and with AEs by maximum grade, related to treatment administration

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    End point title
    Number of patients with any serious adverse events (SAEs) and with AEs by maximum grade, related to treatment administration [33]
    End point description
    SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient, is a Grade 4 AE according to the CTCAE, version3.0. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. SAEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5.
    End point type
    Primary
    End point timeframe
    Within the 31-day follow-up period post treatment administration.
    Notes
    [33] - 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: This outcome was descriptive, hence no statistical analyses were performed.
    End point values
    MAGE-A3 Group
    Number of subjects analysed
    24
    Units: Patients
        Patients with any SAEs
    0
        Patients with G1 SAEs
    0
        Patients with G2 SAEs
    0
        Patients with G3 SAEs
    0
        Patients with G4 SAEs
    0
        Patients with G5 SAEs
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs: From screening (SCR) up to study end; AEs: Within the 31-day follow-up period post treatment administration, up to study end.
    Adverse event reporting additional description
    The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    MAGE-A3 Group
    Reporting group description
    Patients planned to receive intramuscularly up to 24 doses of MAGE-A3 ASCI (the study product), in 4 cycles.

    Serious adverse events
    MAGE-A3 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 24 (8.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic malignant melanoma
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac disorder
         subjects affected / exposed
    1 / 24 (4.17%)
         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
    MAGE-A3 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 24 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic malignant melanoma
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Metastatic pain
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Dyspnoea
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 24 (29.17%)
         occurrences all number
    31
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    12 / 24 (50.00%)
         occurrences all number
    40
    Injection site reaction
         subjects affected / exposed
    12 / 24 (50.00%)
         occurrences all number
    50
    Pyrexia
         subjects affected / exposed
    10 / 24 (41.67%)
         occurrences all number
    31
    Asthenia
         subjects affected / exposed
    9 / 24 (37.50%)
         occurrences all number
    19
    Fatigue
         subjects affected / exposed
    7 / 24 (29.17%)
         occurrences all number
    13
    Influenza like illness
         subjects affected / exposed
    7 / 24 (29.17%)
         occurrences all number
    40
    Chills
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    8
    Injection site erythema
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    7
    Discomfort
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    10
    Administration site pain
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    4
    Injection site induration
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    7
    Ulcer
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    7 / 24 (29.17%)
         occurrences all number
    17
    Diarrhoea
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Hyperhidrosis
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Pruritus
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Myalgia
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    18
    Back pain
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Groin pain
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Infections and infestations
    Skin infection
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 24 (8.33%)
         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 Mar 2009
    The changes following this amendment concern: • The possibility of taking a new tumor biopsy in case the results of the analysis of the biopsies originally taken are inconclusive. • The description of the AJCC staging system for cutaneous melanoma • The AJCC staging system for cutaneous melanoma • The time window for tumor imaging at screening • The expected time for completing patient recruitment

    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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