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    Clinical Trial Results:
    An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma

    Summary
    EudraCT number
    		 2008-004007-64
    Trial protocol
    		 DE   IE   FR   ES   IT   FI  
    Global end of trial date
    16 Sep 2015

    Results information
    Results version number
    		 v3(current)
    This version publication date
    24 Dec 2020
    First version publication date
    24 Mar 2016
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    111476
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00942162
    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, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, 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
    01 Apr 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the clinical activity of the MAGE-A3 ASCI study product in terms of the 1-year overall survival rate (OSR) in patients with MAGE-A3-positive, unresectable stage III or stage IV M1a melanoma tumors presenting the predictive GS.
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Aug 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
    United States: 24
    Country: Number of subjects enrolled
    France: 24
    Country: Number of subjects enrolled
    Germany: 29
    Country: Number of subjects enrolled
    Ireland: 4
    Country: Number of subjects enrolled
    Italy: 25
    Country: Number of subjects enrolled
    Poland: 11
    Country: Number of subjects enrolled
    Russian Federation: 6
    Country: Number of subjects enrolled
    Spain: 2
    Worldwide total number of subjects
    125
    EEA total number of subjects
    95
    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)
    60
    From 65 to 84 years
    65
    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/exclusion criteria, contraindications/precautions, medical history of the patients and signing informed consent forms.

    Pre-assignment period milestones
    Number of subjects started
    		 125
    Number of subjects completed
    		 123

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 no study treatment received: 2
    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
    		 Overall Study 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
    Immunotherapeutic GSK2132231A
    Investigational medicinal product code
    Other name
    recMAGE-A3 recombinant protein + immunological Adjuvant System
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    6 administrations in Cycle 1, at 2-week intervals (Weeks 0, 2, 4, 6, 8 and 10); 6 administrations in Cycle 2, at 3-week intervals (Weeks 14, 17, 20, 23, 26 and 29); 4 administrations in Cycle 3 at 6-week intervals (Weeks 33, 39, 45 and 51) and 4 administrations in Cycle 4 at 3-months (12-weeks) intervals, followed by 4 further administrations at 6-months (24-weeks) intervals at Months 15, 18, 21, 24, 30, 36, 42, and 48.

    Number of subjects in period 1 [1]
    		Overall Study Group
    Started
    123
    Completed
    1
    Not completed
    122
         Consent withdrawn by subject
    9
         Death
    80
         Unspecified
    29
         Lost to follow-up
    4
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: While 125 subjects were enrolled, only 123 started the study, as 2 subjects did not receive treatment and were excluded.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study 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
    		 Overall Study Group Total
    Number of subjects
    		 123 123
    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)
    		 64.9 ( 13.45 ) -
    Gender categorical
    Units: Subjects
        Female
    		 65 65
        Male
    		 58 58
    Subject analysis sets

    Subject analysis set title
    GSK2132231A 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 potentially predictive gene signature, as assessed at screening.

    Subject analysis set title
    GSK2132231A GS- Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subset of patients without the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.

    Subject analysis set title
    GSK2132231A GS-unknown Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subset of patients with unknown status as regards GS signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.

    Subject analysis sets values
    		 GSK2132231A GS+ Group GSK2132231A GS- Group GSK2132231A GS-unknown Group
    Number of subjects
    71
    50
    2
    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)
    66.9 ( 13.9 )
    62.1 ( 12.6 )
    60.5 ( 6.36 )
    Gender categorical
    Units: Subjects
        Female
    42
    23
    0
        Male
    29
    27
    2

    End points

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    End points reporting groups
    Reporting group title
    Overall Study 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
    GSK2132231A 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 potentially predictive gene signature, as assessed at screening.

    Subject analysis set title
    GSK2132231A GS- Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subset of patients without the pre-specified gene signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.

    Subject analysis set title
    GSK2132231A GS-unknown Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subset of patients with unknown status as regards GS signature, receiving the MAGE-A3 ASCI product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.

    Primary: One-year overall survival rate (OSR) estimated by complete case method

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    End point title
    		 One-year overall survival rate (OSR) estimated by complete case method [1]
    End point description
    The 1-year overall survival rate (OSR) in the GS+ Population would be above 50% (target = 71%), a proportion which was reported together with its 95% confidence interval (CI). Maximum 1-year OSR of any currently available treatment in the MAGE-A3-positive population = 50% (P0). This median OS of 12 months is based on the observed median OS for MAGE-A3-positive patients, whose tumor did not present the predictive GS. The target 1-year OSR for patients presenting the predictive GS = 71% (P1). This corresponds to a median OS of 24 months when assuming an exponential distribution of OS.
    End point type
    Primary
    End point timeframe
    From Month 0 to Month 12
    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: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 GSK2132231A GS+ Group GSK2132231A GS- Group GSK2132231A GS-unknown Group
    Number of subjects analysed
    65
    48
    2
    Units: Percentage of participants
    number (confidence interval 95%)
        OSR
    83.08 (71.73 to 91.24)
    83.33 (69.78 to 92.52)
    100 (15.81 to 100)
    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) [2]
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Events which were part of the natural course of the disease under study (i.e., disease progression, recurrence) were captured as part of the clinical activity outcome variables in this study; therefore these did not need to be reported as SAEs. Progression/recurrence of the tumor in a patient 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 (From Month 0 to Month 49)
    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: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Overall Study Group
    Number of subjects analysed
    123
    Units: Patients
        Any SAEs
    19
    No statistical analyses for this end point

    Secondary: Number of patients with diseases characteristics by GS

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    End point title
    		 Number of patients with diseases characteristics by GS
    End point description
    Cancer staging (characteristics and categories) as by the categorization by the AJCC Cancer Staging Manual 2002.
    End point type
    Secondary
    End point timeframe
    During the entire study period (From Month 0 to Month 49)
    End point values
    		 GSK2132231A GS+ Group GSK2132231A GS- Group GSK2132231A GS-unknown Group
    Number of subjects analysed
    71
    50
    2
    Units: Patients
        STAGE IIIA
    0
    0
    0
        STAGE IIIB
    11
    4
    1
        STAGE IIIC
    21
    19
    1
        STAGE IV
    39
    27
    0
        STAGE MC
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Progression-free survival (PFS) by GS

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    End point title
    		 Progression-free survival (PFS) by GS
    End point description
    From study start to Month 24, each patient being censored out of the analysis at 1st report of disease progression or death. PFS was defined and calculated as the time from first treatment to either the first progression of the disease or the date of death, whichever occurred first. In case a patient went off protocol treatment, the date of first documented progression (if applicable) was to be used as date of progression. Patients still alive with no evidence of disease progression at the time of their last visit or for whom date of first documented progression was not applicable, were censored at the time of the last examination. PFS analysis was performed using the non-parametric Kaplan-Meier method.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 24
    End point values
    		 Overall Study Group GSK2132231A GS+ Group GSK2132231A GS- Group
    Number of subjects analysed
    123
    71
    50
    Units: Months
    median (confidence interval 95%)
        PFS
    2.8 (2.8 to 2.8)
    2.8 (2.8 to 2.9)
    2.8 (2.5 to 2.8)
    No statistical analyses for this end point

    Secondary: Kaplan-Meier estimates of the Progression-free Survival (PFS) at Months 6, 12 and 24, by Gene Signature

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    End point title
    		 Kaplan-Meier estimates of the Progression-free Survival (PFS) at Months 6, 12 and 24, by Gene Signature
    End point description
    PFS was defined as the time from the date of registration of the patient to either the date of disease progression or the date of death (for whatever reason), whichever comes first. Patients alive and without disease progression were censored at the date of their last tumor evaluation. The PFS estimates were assessed by the Kaplan-Meier method and expressed as the percentage of patients who did not progress and were alive at a given time.
    End point type
    Secondary
    End point timeframe
    At Month 6, Month 12 and Month 24
    End point values
    		 GSK2132231A GS+ Group GSK2132231A GS- Group
    Number of subjects analysed
    71
    50
    Units: Percentage of subjects
    number (confidence interval 95%)
        PFS 6M [71;50]
    13.53 (6.71 to 22.75)
    5 (1 to 14.22)
        PFS 12M [71;50]
    6.02 (1.95 to 13.43)
    5 (1 to 14.22)
        PFS 24M [71;50]
    1.5 (0.13 to 7.12)
    5 (1 to 14.22)
    No statistical analyses for this end point

    Secondary: Overall survival (OS) by GS

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    End point title
    		 Overall survival (OS) by GS
    End point description
    OS was defined as defined as the time from registration of the patient until death, with patients alive at the time of analysis censored at the time of the last contact.
    End point type
    Secondary
    End point timeframe
    Up to 5 years from the time of registration
    End point values
    		 Overall Study Group GSK2132231A GS+ Group GSK2132231A GS- Group
    Number of subjects analysed
    123
    71
    50
    Units: Months
    median (confidence interval 95%)
        OS
    23.9 (19.2 to 28.2)
    20.6 (16.1 to 28.2)
    25.8 (18.4 to 35.5)
    No statistical analyses for this end point

    Secondary: Time to treatment failure (TTF) by GS

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    End point title
    		 Time to treatment failure (TTF) by GS
    End point description
    The TTF was defined as the time from registration of the patient until the date of the last treatment administration, irrespective of the reason for study treatment discontinuation.
    End point type
    Secondary
    End point timeframe
    During the 24 months period (From Month 0 to Month 24).
    End point values
    		 Overall Study Group GSK2132231A GS+ Group GSK2132231A GS- Group
    Number of subjects analysed
    123
    71
    50
    Units: Months
    median (confidence interval 95%)
        TTF
    2.5 (2.4 to 4.1)
    2.7 (2.4 to 5.4)
    2.4 (2.3 to 2.6)
    No statistical analyses for this end point

    Secondary: Best overall response (BOR) by GS

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    End point title
    		 Best overall response (BOR) by GS
    End point description
    The best overall response was the best response recorded from the start of the treatment until disease progression/recurrence, except for confirmed objective response, which was reported as BOR independently of its time of occurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions without any new lesions and/or progression of existing non-target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD) without any new lesions and/or progression of existing non-target lesions; PD, >=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; NE = Non-evaluable response.
    End point type
    Secondary
    End point timeframe
    During the 24 months period (From Month 0 to Month 24)
    End point values
    		 GSK2132231A GS+ Group GSK2132231A GS- Group GSK2132231A GS-unknown Group
    Number of subjects analysed
    71
    50
    2
    Units: Patients
        CR
    0
    1
    0
        PR
    3
    0
    0
        SD
    11
    4
    0
        SD/PR
    3
    0
    0
        PD
    51
    44
    2
        NE
    3
    1
    0
        Missing
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of response (CR or PR) by GS

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    End point title
    		 Duration of response (CR or PR) by GS
    End point description
    Duration of response was measured from the time when the measurement criteria for CR/PR (whichever was recorded first) were met until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started). Note: As there was only one patient analyzed in the GS- Subgroup, the median duration of response was not calculated for this latter subgroup. When only 1 subject is analyzed, the lower limit (LL) and the upper limit (UL) are entered equal to the geometric mean concentration (GMC) value as the confidence interval could not be calculated with only 1 subject analyzed.
    End point type
    Secondary
    End point timeframe
    During the 24 months period (From Month 0 to Month 24)
    End point values
    		 Overall Study Group GSK2132231A GS+ Group GSK2132231A GS- Group
    Number of subjects analysed
    4
    3
    1
    Units: Months
    median (confidence interval 95%)
        CR/PR
    8.3 (1.9 to 8.3)
    6.9 (1.9 to 9.7)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Duration of stable disease (SD), or Time-to-Progression (TTP) by GS

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    End point title
    		 Duration of stable disease (SD), or Time-to-Progression (TTP) by GS
    End point description
    The duration of stable disease (SD), or TTP, was tabulated for patients whose best response was SD. The minimal time interval required between 2 measurements for determination of SD was 12 weeks.
    End point type
    Secondary
    End point timeframe
    During the 24 months period (From Month 0 to Month 24)
    End point values
    		 Overall Study Group GSK2132231A GS+ Group GSK2132231A GS- Group
    Number of subjects analysed
    15
    11
    4
    Units: Months
    median (confidence interval 95%)
        SD/TTP
    5.4 (5.1 to 9.4)
    5.4 (4.1 to 9.4)
    5.4 (5.1 to 25)
    No statistical analyses for this end point

    Secondary: Number of seropositive patients for anti-MAGE-A3

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    End point title
    		 Number of seropositive patients for anti-MAGE-A3
    End point description
    Seropositive patients were those patients with anti-MAGE-A3 antibody concentrations ≥ 27 ELISA units per millilitre (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    PRE = Pre any dose, PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49).
    End point values
    		 Overall Study Group GSK2132231A GS+ Group GSK2132231A GS- Group GSK2132231A GS-unknown Group
    Number of subjects analysed
    87
    52
    34
    1
    Units: Patients
        Anti-MAGE-A3, PRE [N=87;52;34;1]
    7
    4
    3
    0
        Anti-MAGE-A3, PII(W4) [N=62;39;22;1]
    60
    37
    22
    1
        Anti-MAGE-A3, PVI(W12) [N=52;34;17;1]
    52
    34
    17
    1
        Anti-MAGE-A3, PXII(W31) [N=11;5;6;0]
    11
    5
    6
    0
        Anti-MAGE-A3, PXVI(W54) [N=6;3;3;0]
    6
    3
    3
    0
        Anti-MAGE-A3, PXVII(M18) [N=3;2;1;0]
    3
    2
    1
    0
        Anti-MAGE-A3, PXXIV(M49) [N=4;4;0;0]
    4
    4
    0
    0
    No statistical analyses for this end point

    Secondary: Anti-MAGE-A3 antibody concentrations

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    End point title
    		 Anti-MAGE-A3 antibody concentrations
    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). When only 1 subject is analyzed, the lower limit (LL) and the upper limit (UL) are entered equal to the geometric mean concentration (GMC) value as the confidence interval could not be calculated with only 1 subject analyzed.
    End point type
    Secondary
    End point timeframe
    PRE = Pre any dose, PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49).
    End point values
    		 Overall Study Group GSK2132231A GS+ Group GSK2132231A GS- Group GSK2132231A GS-unknown Group
    Number of subjects analysed
    87
    52
    34
    1
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-MAGE-A3, PRE [N=87;52;34;1]
    11.2 (10.3 to 12.2)
    11.2 (10 to 12.5)
    11.3 (9.8 to 13)
    10 (10 to 10)
        Anti-MAGE-A3, PII(W4) [N=62;39;22;1]
    906.1 (608 to 1350.2)
    728.7 (406 to 1307.9)
    1385.7 (896.4 to 2142)
    387 (387 to 387)
        Anti-MAGE-A3, PVI(W12) [N=52;34;17;1]
    6190.1 (5007.6 to 7652)
    5631 (4284.9 to 7399.8)
    7500.1 (5165.9 to 10889.2)
    5921 (5921 to 5921)
        Anti-MAGE-A3, PXII(W31) [N=11;5;6;0]
    6724.2 (3978 to 11366.4)
    7094.2 (2360 to 21325.5)
    6430.7 (2877.3 to 14372.4)
    0 (0 to 0)
        Anti-MAGE-A3, PXVI(W54) [N=6;3;3;0]
    3289.8 (1575.4 to 6870)
    2570.9 (480.1 to 13765.9)
    4209.7 (622.4 to 28473.7)
    0 (0 to 0)
        Anti-MAGE-A3, PXVII(M18) [N=3;2;1;0]
    4118.6 (1557.3 to 10892.7)
    4784.5 (115.5 to 198255.8)
    3052 (3052 to 3052)
    0 (0 to 0)
        Anti-MAGE-A3, PXXIV(M49) [N=4;4;0;0]
    7063.9 (3780.4 to 13199.4)
    7063.9 (3780.4 to 13199.4)
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of seropositive patients for protein D

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    End point title
    		 Number of seropositive patients for protein D
    End point description
    Seropositive patients were those patients with anti-PD antibody concentrations ≥ 100 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    PRE = Pre any dose, PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49)
    End point values
    		 Overall Study Group GSK2132231A GS+ Group GSK2132231A GS- Group GSK2132231A GS-unknown Group
    Number of subjects analysed
    88
    53
    34
    1
    Units: Patients
        Anti-PD, PRE [N=88;53;34;1]
    29
    20
    8
    1
        Anti-PD, PII(W4) [N=77;46;30;1]
    77
    46
    30
    1
        Anti-PD, PVI(W12) [N=52;34;17;1]
    52
    34
    17
    1
        Anti-PD, PXII(W31) [N=11;5;6;0]
    11
    5
    6
    0
        Anti-PD, PXVI(W54) [N=6;3;3;0]
    6
    3
    3
    0
        Anti-PD, PXVII(M18) [N=3;2;1;0]
    3
    2
    1
    0
        Anti-PD, PXXIV(M49) [N=4;4;0;0]
    4
    4
    0
    0
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against protein D (Anti-PD)

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    End point title
    		 Concentrations of antibodies against protein D (Anti-PD)
    End point description
    Anti-PD antibody concentrations were presented ad geometric mean concentrations (GMTs) and expressed in EL.U/mL. When only 1 subject is analyzed, the lower limit (LL) and the upper limit (UL) are entered equal to the geometric mean concentration (GMC) value as the confidence interval could not be calculated with only 1 subject analyzed.
    End point type
    Secondary
    End point timeframe
    PRE = Pre any dose, PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18)= Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49)
    End point values
    		 Overall Study Group GSK2132231A GS+ Group GSK2132231A GS- Group GSK2132231A GS-unknown Group
    Number of subjects analysed
    88
    53
    34
    1
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD, PRE [N=88;53;34;1]
    81.2 (68.5 to 96.2)
    86.1 (68.9 to 107.5)
    70.6 (54.5 to 91.5)
    412 (412 to 412)
        Anti-PD, PII(W4) [N=77;46;30;1]
    4588 (3397.5 to 6195.7)
    4196.9 (2768 to 6363.3)
    5139.8 (3253.3 to 8120.2)
    9167 (9167 to 9167)
        Anti-PD, PVI(W12) [N=52;34;17;1]
    15036.7 (12057.7 to 18751.5)
    14091.9 (10763.7 to 18449.4)
    16453.2 (10607.9 to 25519.6)
    29553 (29553 to 29553)
        Anti-PD, PXII(W31) [N=11;5;6;0]
    23548.6 (15167.2 to 36561.6)
    25070.5 (8468.5 to 74220)
    22351.2 (13378 to 37343.1)
    0 (0 to 0)
        Anti-PD, PXVI(W54) [N=6;3;3;0]
    12389.9 (6229 to 24644.4)
    9639.2 (1286.9 to 72202.6)
    15925.5 (4872 to 52057)
    0 (0 to 0)
        Anti-PD, PXVII(M18) [N=3;2;1;0]
    11386.1 (3141.7 to 41265.3)
    13839.4 (93.9 to 2040751)
    7707 (7707 to 7707)
    0 (0 to 0)
        Anti-PD, PXXIV(M49) [N=4;4;0;0]
    10546.9 (1777.2 to 62591.1)
    10546.9 (1777.2 to 62591.1)
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Anti-MAGE-A3 antibody response

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    End point title
    		 Anti-MAGE-A3 antibody response
    End point description
    Anti-MAGE-A3 antibody response defined as: For initially seronegative patients: post-vaccination antibody concentration ≥ 27 EL.U/mL. For initially seropositive patients: post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration
    End point type
    Secondary
    End point timeframe
    PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49)
    End point values
    		 Overall Study Group GSK2132231A GS+ Group GSK2132231A GS- Group GSK2132231A GS-unknown Group
    Number of subjects analysed
    62
    39
    22
    1
    Units: Patients
        Anti-MAGE-A3, PII(W4) [N=62;39;22;1]
    60
    37
    22
    1
        Anti-MAGE-A3, PVI(W12) [N=52;34;17;1]
    52
    34
    17
    1
        Anti-MAGE-A3, PXII(W31) [N=11;5;6;0]
    11
    5
    6
    0
        Anti-MAGE-A3, PXVI(W54) [N=6;3;3;0]
    6
    3
    3
    0
        Anti-MAGE-A3, PXVII(M18) [N=3;2;1;0]
    3
    2
    1
    0
        Anti-MAGE-A3, PXXIV(M49) [N=4;4;0;0]
    4
    4
    0
    0
    No statistical analyses for this end point

    Secondary: Anti-PD antibody response

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    End point title
    		 Anti-PD antibody response
    End point description
    Anti-PD antibody response defined as: For initially seronegative patients: post-vaccination antibody concentration ≥ 100 EL.U/mL. For initially seropositive patients: post-vaccination antibody concentration ≥ 2 fold the pre-vaccination antibody concentration
    End point type
    Secondary
    End point timeframe
    PII(W4) = Post-Dose 2 (Week 4), PVI(W12) = Post-Dose 6 (Week 12), PXII(W31) = Post-Dose 12 (Week 31), PXVI(W54) = Post-Dose 16 (Week 54), PXVII(M18) = Post-Dose 17 (Month 18), PXXIV(M49) = Post-Dose 24 (Month 49)
    End point values
    		 Overall Study Group GSK2132231A GS+ Group GSK2132231A GS- Group GSK2132231A GS-unknown Group
    Number of subjects analysed
    77
    46
    30
    1
    Units: Patients
        Anti-PD, PII(W4) [N=77;46;30;1]
    76
    45
    30
    1
        Anti-PD, PVI(W12) [N=52;34;17;1]
    52
    34
    17
    1
        Anti-PD, PXII(W31) [N=11;5;6;0]
    11
    5
    6
    0
        Anti-PD, PXVI(W54) [N=6;3;3;0]
    6
    3
    3
    0
        Anti-PD, PXVII(M18) [N=3;2;1;0]
    3
    2
    1
    0
        Anti-PD, PXXIV(M49) [N=4;4;0;0]
    4
    4
    0
    0
    No statistical analyses for this end point

    Secondary: 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
    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) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3 and Unknown (UNK).
    End point type
    Secondary
    End point timeframe
    From study start to study end (Month 0 - Month 49), each patient being censored out of the analysis at time of death
    End point values
    		 Overall Study Group
    Number of subjects analysed
    123
    Units: Patients
        ALT - SCR G0; SE G0
    100
        ALT - SCR G0; SE G1
    8
        ALT - SCR G0; SE G2
    1
        ALT - SCR G0; SE G3
    1
        ALT - SCR G0; SE UNK
    1
        ALT - SCR G1; SE G0
    3
        ALT - SCR G1; SE G1
    8
        ALT - SCR G1; SE G2
    1
    No statistical analyses for this end point

    Secondary: 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
    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 were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1 and Unknown (UNK).
    End point type
    Secondary
    End point timeframe
    From study start to study end (Month 0 - Month 49), each patient being censored out of the analysis at time of death.
    End point values
    		 Overall Study Group
    Number of subjects analysed
    123
    Units: Patients
        AST - SCR G0; SE G0
    101
        AST - SCR G0; SE G1
    12
        AST - SCR G0; SE UNK
    1
        AST - SCR G1; SE G0
    6
        AST - SCR G1; SE G1
    3
    No statistical analyses for this end point

    Secondary: 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
    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 Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1 and Unknown (UNK).
    End point type
    Secondary
    End point timeframe
    From study start to study end (Month 0 - Month 49), each patient being censored out of the analysis at time of death.
    End point values
    		 Overall Study Group
    Number of subjects analysed
    123
    Units: Patients
        ALK - SCR G0; SE G0
    103
        ALK - SCR G0; SE G1
    7
        ALK - SCR G0; SE UNK
    1
        ALK - SCR G1; SE G0
    5
        ALK - SCR G1; SE G1
    7
    No statistical analyses for this end point

    Secondary: 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
    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 were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2 and Unknown (UNK).
    End point type
    Secondary
    End point timeframe
    From study start to study end (Month 0 - Month 49), each patient being censored out of the analysis at time of death.
    End point values
    		 Overall Study Group
    Number of subjects analysed
    123
    Units: Patients
        BIL - SCR G0; SE G0
    113
        BIL - SCR G0; SE G1
    5
        BIL - SCR G0; SE UNK
    1
        BIL - SCR G1; SE G0
    2
        BIL - SCR G2; SE G1
    1
        BIL - SCR G2; SE G2
    1
    No statistical analyses for this end point

    Secondary: 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
    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), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2 and Unknown (UNK).
    End point type
    Secondary
    End point timeframe
    From study start to study end (Month 0 - Month 49), each patient being censored out of the analysis at time of death.
    End point values
    		 Overall Study Group
    Number of subjects analysed
    123
    Units: Patients
        CREA - SCR G0; SE G0
    105
        CREA - SCR G0; SE G1
    7
        CREA - SCR G0; SE UNK
    1
        CREA - SCR G1; SE G0
    1
        CREA - SCR G1; SE G1
    6
        CREA - SCR G1; SE G2
    2
        CREA - SCR G2; SE G2
    1
    No statistical analyses for this end point

    Secondary: 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
    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), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).
    End point type
    Secondary
    End point timeframe
    From study start to study end (Month 0 - Month 49), each patient being censored out of the analysis at time of death.
    End point values
    		 Overall Study Group
    Number of subjects analysed
    123
    Units: Patients
        HGB - SCR G0; SE G0
    61
        HGB - SCR G0; SE G1
    30
        HGB - SCR G0; SE G2
    1
        HGB - SCR G0; SE G3
    1
        HGB - SCR G0; SE UNK
    1
        HGB - SCR G1; SE G0
    1
        HGB - SCR G1; SE G1
    16
        HGB - SCR G1; SE G2
    6
        HGB - SCR G1; SE G3
    3
        HGB - SCR G1; SE G4
    1
        HGB - SCR G2; SE G0
    1
        HGB - SCR G2; SE G2
    1
    No statistical analyses for this end point

    Secondary: 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
    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), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G4, and Unknown (UNK).
    End point type
    Secondary
    End point timeframe
    From study start to study end (Month 0 - Month 49), each patient being censored out of the analysis at time of death.
    End point values
    		 Overall Study Group
    Number of subjects analysed
    123
    Units: Patients
        LEU - SCR G0; SE G0
    99
        LEU - SCR G0; SE G1
    10
        LEU - SCR G0; SE G2
    1
        LEU - SCR G0; SE G4
    1
        LEU - SCR G0; SE UNK
    1
        LEU - SCR G1; SE G0
    6
        LEU - SCR G1; SE G1
    3
        LEU - SCR G1; SE G2
    1
        LEU - SCR G2; SE G1
    1
    No statistical analyses for this end point

    Secondary: 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
    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), G1, G2 and G3. CTC grade statuses reported at SE were G0, G1, G2, G3 and Unknown (UNK).
    End point type
    Secondary
    End point timeframe
    From study start to study end (Month 0 - Month 49), each patient being censored out of the analysis at time of death.
    End point values
    		 Overall Study Group
    Number of subjects analysed
    123
    Units: Patients
        LYM - SCR G0; SE G0
    67
        LYM - SCR G0; SE G1
    18
        LYM - SCR G0; SE G2
    3
        LYM - SCR G0; SE UNK
    1
        LYM - SCR G1; SE G0
    3
        LYM - SCR G1; SE G1
    23
        LYM - SCR G1; SE G2
    4
        LYM - SCR G2; SE G2
    1
        LYM - SCR G2; SE G3
    1
        LYM - SCR G3; SE G3
    2
    No statistical analyses for this end point

    Secondary: 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
    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 were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3 and Unknown (UNK).
    End point type
    Secondary
    End point timeframe
    From study start to study end (Month 0 - Month 49), each patient being censored out of the analysis at time of death.
    End point values
    		 Overall Study Group
    Number of subjects analysed
    123
    Units: Patients
        NEU - SCR G0; SE G0
    108
        NEU - SCR G0; SE G1
    4
        NEU - SCR G0; SE G2
    1
        NEU - SCR G0; SE UNK
    1
        NEU - SCR G1; SE G0
    2
        NEU - SCR G1; SE G1
    5
        NEU - SCR G1; SE G3
    1
        NEU - SCR G2; SE G1
    1
    No statistical analyses for this end point

    Secondary: 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
    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 were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G4, and Unknown (UNK).
    End point type
    Secondary
    End point timeframe
    From study start to study end (Month 0 - Month 49), each patient being censored out of the analysis at time of death.
    End point values
    		 Overall Study Group
    Number of subjects analysed
    123
    Units: Patients
        PLT - SCR G0; SE G0
    112
        PLT - SCR G0; SE G1
    5
        PLT - SCR G0; SE G4
    1
        PLT - SCR G0; SE UNK
    1
        PLT - SCR G1; SE G1
    4
    No statistical analyses for this end point

    Secondary: Number of patients with autoimmune diseases or immune-mediated inflammatory disorders

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    End point title
    		 Number of patients with autoimmune diseases or immune-mediated inflammatory disorders
    End point description
    Auto-immune diseases or immune-mediated inflammatory disorders were tabulated during the whole duration of the study (up to 30 days after the last administration of the study treatment).
    End point type
    Secondary
    End point timeframe
    During the whole study period (From Month 0 to Month 49)
    End point values
    		 Overall Study Group
    Number of subjects analysed
    123
    Units: Patients
        Any event(s)
    4
    No statistical analyses for this end point

    Secondary: Number of patients reported with unsolicited adverse events (AEs) by maximum grade.

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    End point title
    		 Number of patients reported with unsolicited adverse events (AEs) by maximum grade.
    End point description
    The assessed AEs were ASCI-related adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death due to AE. 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
    End point type
    Secondary
    End point timeframe
    Through 30 days after the last administration of the study treatment, approximately 49 months
    End point values
    		 Overall Study Group
    Number of subjects analysed
    123
    Units: Patients
        Any event, Grade 1
    52
        Any event, Grade 2
    35
        Any event, Grade 3
    21
        Any event, Grade 4
    5
        Any event, Grade 5
    3
    No statistical analyses for this end point

    Secondary: Number of patients reported with unsolicited AE(s)

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    End point title
    		 Number of patients reported with unsolicited AE(s)
    End point description
    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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
    End point type
    Secondary
    End point timeframe
    Through 30 days after the last administration of the study treatment, approximately 49 months
    End point values
    		 Overall Study Group
    Number of subjects analysed
    123
    Units: Patients
        Any AE(s)
    116
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs up to 30 days post treatment; SAEs during the entire study period (from Month 0 to Month 49).
    Adverse event reporting additional description
    As planned per study protocol, safety was assessed in the overall population regardless of GS status.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Overall Study 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
    		 Overall Study Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 123 (15.45%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Vascular disorders
    Lymphoedema
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Phlebitis
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cognitive disorder
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Guillain-Barre syndrome
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotonia
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia of chronic disease
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Multi-organ failure
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Autoimmune colitis
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    2 / 123 (1.63%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 123 (0.81%)
         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
    		 Overall Study Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    107 / 123 (86.99%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 123 (11.38%)
         occurrences all number
    20
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    17 / 123 (13.82%)
         occurrences all number
    42
    Chills
         subjects affected / exposed
    21 / 123 (17.07%)
         occurrences all number
    42
    Fatigue
         subjects affected / exposed
    30 / 123 (24.39%)
         occurrences all number
    110
    Influenza like illness
         subjects affected / exposed
    15 / 123 (12.20%)
         occurrences all number
    46
    Injection site erythema
         subjects affected / exposed
    21 / 123 (17.07%)
         occurrences all number
    53
    Injection site pain
         subjects affected / exposed
    60 / 123 (48.78%)
         occurrences all number
    193
    Injection site reaction
         subjects affected / exposed
    9 / 123 (7.32%)
         occurrences all number
    38
    Pain
         subjects affected / exposed
    11 / 123 (8.94%)
         occurrences all number
    11
    Pyrexia
         subjects affected / exposed
    41 / 123 (33.33%)
         occurrences all number
    155
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    10 / 123 (8.13%)
         occurrences all number
    22
    Diarrhoea
         subjects affected / exposed
    13 / 123 (10.57%)
         occurrences all number
    32
    Nausea
         subjects affected / exposed
    15 / 123 (12.20%)
         occurrences all number
    35
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 123 (6.50%)
         occurrences all number
    10
    Dyspnoea
         subjects affected / exposed
    7 / 123 (5.69%)
         occurrences all number
    20
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 123 (7.32%)
         occurrences all number
    12
    Myalgia
         subjects affected / exposed
    12 / 123 (9.76%)
         occurrences all number
    96
    Pain in extremity
         subjects affected / exposed
    18 / 123 (14.63%)
         occurrences all number
    25

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jan 2011
    The main changes in Amendment 1 concern: 1. The addition of an interim analysis for the early assessment of the predictive value of the gene signature (Statistical analysis, Section 10). The interim analysis will assess all available safety and clinical activity data at the time at least 36 enrolled patients have been followed up for one year or have died. Amongst these 36 patients, 18 should have a tumor with the predictive gene signature. The original version of the protocol specified a fixed sample size study of 51 patients with the predictive gene signature having started protocol treatment and having been followed for at least 1 year (or having died). The implementation of a group sequential test design with two stages in the amendment leads to an increase in final sample size from 51 to 53 patients with the predictive gene signature having started protocol treatment and having been followed for at least 1 year (or having died). Assumptions and details of the statistical considerations are described below in Section 10.3. Moreover, in this amendment, it has been specified that the final analysis will take place approximately one year after last patient’s first visit and that updated analysis of overall survival will be performed on a yearly basis until all patients have been followed up for 5 years. 2. Contact information for reporting SAEs has been updated. 3. A new section (Section 6.3.7) has been introduced describing all the remaining Visits/procedures to be performed by patients withdrawn from study treatment. 4. An appendix was added with recommendations for biopsy collection (refer to Appendix B).
    08 Sep 2014
    Amendment 2: The main changes in Amendment 2 : • Removal of all active follow-up visits and procedures, • Removal of blood sampling for humoral immunological response and PBMC collection at the end of Cycle 4, • Clarifications regarding the decision to not perform further testing on samples already collected in the study but not tested yet, in the following sections: • Synopsis, • Objectives, • Biologicals sample handling and analysis, • Translational Research, • Secondary endpoints, • Analysis of immunogenicity, • Translational research analysis. • The section ‘Final analysis’ was updated.

    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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