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    Clinical Trial Results:
    A Phase 1/2 Study to Evaluate the Safety, Tolerability, Immune Response, and Clinical Efficacy of Cancer Peptide Vaccine S-488210 in Patients with Unresectable Locoregionally Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

    Summary
    EudraCT number
    2011-005014-12
    Trial protocol
    BE   DE  
    Global end of trial date
    15 Jul 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    09 Jul 2016
    First version publication date
    01 Aug 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    update needed due to EdraCT downtime in the period Jul-2015-Jan2016

    Trial information

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    Trial identification
    Sponsor protocol code
    1122P1811
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Shionogi & Co., Ltd.
    Sponsor organisation address
    1-8 Doshomachi 3-chome Chuo-ku, Osaka/Osaka, Japan, 541-0045
    Public contact
    Kenji Igarashi, Shionogi & Co., Ltd., +81 664855082, kenji.igarashi@shionogi.co.jp
    Scientific contact
    Kenji Igarashi, Shionogi & Co., Ltd., +81 664855082, kenji.igarashi@shionogi.co.jp
    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
    19 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of S-488210 in human leukocyte antigen (HLA)-A*02:01-positive patients with HNSCC receiving 4 vaccinations of S-488210 at a dose of 1 mg each of the 3 peptides on a weekly basis
    Protection of trial subjects
    1st IDMC meeting:21 Oct 2013, Review of safety data for first 6 patients who received 4 weeks of treatment 2nd IDMC meeting: 25 Mar 2014: Review of safety data for first 6 patients and immune response data of those patients. No safety issues were noticed from both meetings.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Jan 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy
    Long term follow-up duration
    6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Germany: 3
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    4
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    First site activated: 25 July 2012. Recruitment stopped 31 December 2013. Type of location was medical hospital.

    Pre-assignment
    Screening details
    -

    Pre-assignment period milestones
    Number of subjects started
    28 [1]
    Number of subjects completed
    7

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    protocol exclusion criteria met: 21
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Justification: The reported 24 patients were the number of patients planned per protocol. A total of 28 patients were enrolled, and of these patients at least 7 received 1 dose of the study drug. The error in the database occurs because Eudra pulled data from the initial Belgium CT application where the planned number of patients per protocol was filled in (24) and then it compared that number with the actual number of patients screened enrolled in phase 1 (28).
    Period 1
    Period 1 title
    Step 1(Visit 1-4), Step 2(v5-withdrawal) (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    S-488210
    Arm description
    injection of S-488210 once a week over 4-week treatment period followed by extension period, and every 2 weeks after week 13
    Arm type
    Experimental

    Investigational medicinal product name
    not available yet
    Investigational medicinal product code
    S-488210
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3 mg per day

    Number of subjects in period 1
    S-488210
    Started
    7
    4 injections of S-488210
    7
    Completed
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Step 1(Visit 1-4), Step 2(v5-withdrawal)
    Reporting group description
    Injection of S-488210 once a week over 4 weeks treatment period followed by extension period

    Reporting group values
    Step 1(Visit 1-4), Step 2(v5-withdrawal) Total
    Number of subjects
    7 7
    Age categorical
    injection of S-488210 once a week over a 4-week treatment period followed by extension period.
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    4 4
        From 65-84 years
    3 3
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    60.4 ± 8.66 -
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    7 7
    Subject analysis sets

    Subject analysis set title
    safety analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All patients who received at least 1 dose of study drug

    Subject analysis set title
    full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All patients who received at least 1 dose of study drug

    Subject analysis sets values
    safety analysis set full analysis set
    Number of subjects
    7
    7
    Age categorical
    injection of S-488210 once a week over a 4-week treatment period followed by extension period.
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    4
    4
        From 65-84 years
    3
    3
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    60.4 ± 8.66
    60.4 ± 8.66
    Gender categorical
    Units: Subjects
        Female
    0
    0
        Male
    7
    7

    End points

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    End points reporting groups
    Reporting group title
    S-488210
    Reporting group description
    injection of S-488210 once a week over 4-week treatment period followed by extension period, and every 2 weeks after week 13

    Subject analysis set title
    safety analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All patients who received at least 1 dose of study drug

    Subject analysis set title
    full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All patients who received at least 1 dose of study drug

    Primary: The number and percentage of patients with at least 1 treatment-emergent AEs (TEAE)

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    End point title
    The number and percentage of patients with at least 1 treatment-emergent AEs (TEAE) [1]
    End point description
    Adverse events were assessed from the date the ICF was signed up to 30 days after the last dose of study drug. TEAE was defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to study drug.
    End point type
    Primary
    End point timeframe
    Duration from the date the ICF was signed up to 30 days after the last dose of study drug
    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: Justification: Shionogi would not perform any statistical analysis as per protocol since Shionogi & Co, Ltd has decided to terminate phase 2 part because of changing the formula of the cancer peptide vaccine S-488210.
    End point values
    S-488210 safety analysis set
    Number of subjects analysed
    7 [2]
    7 [3]
    Units: subjects
    7
    7
    Notes
    [2] - Patients experienced TEAEs
    [3] - Patients experienced TEAEs
    No statistical analyses for this end point

    Secondary: Cytotoxic T Lymphocyte Induction Rate

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    End point title
    Cytotoxic T Lymphocyte Induction Rate
    End point description
    Cytotoxic T lymphocyte induction was defined as increased CTL activity compared with baseline
    End point type
    Secondary
    End point timeframe
    Every 4 week until 12 weeks
    End point values
    S-488210 full analysis set
    Number of subjects analysed
    6
    6
    Units: subjects
    6
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were assessed from the date the ICF was signed up to 30 days after the last dose of the study drug.
    Adverse event reporting additional description
    A treatment-emergent AE (TEAE) was defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to study drug. Total No of TEAEs, No and % of patients with at least 1 TEAE were tabulated along with the No and % of patients by system/organ/class and pr term
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    S-488210
    Reporting group description
    Injection of S-488210 once a week over 4 week treatment period followed by extension period

    Serious adverse events
    S-488210
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 7 (42.86%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Disease progression
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Non cardiac chest pain
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    S-488210
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    Vascular disorders
    Lymphoedema
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Immune system disorders
    Contrast media allergy
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    7
    Injection site erythema
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    7
    Asthenia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Injection site papule
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Injection site pruritus
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Confusional state
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Oropharyngeal pain
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Presyncope
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    7
    Dysphagia
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    7
    Vomiting
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    7
    Diarrhoea
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Nausea
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Skin and subcutaneous tissue disorders
    Ecchymosis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Pruritus
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    7
    Arthralgia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Feb 2013
    Amendment 3, Protocol version 4.0 - Inclusion criterion 9 was updated to remove the upper age limit. - Exclusion criterion 2 was updated to clarify that only patients with proof or suggestion of active infection will be excluded. - Exclusion criterion 17 was updated to change the allowable time period for previous use of another investigational product from “within 60 days of enrollment” to “within 28 days of enrollment”.
    21 Jun 2013
    Amendment 4, Protocol version 5.0 • Exclusion criterion 3 was updated to clarify that the exclusion of patients with human papilloma virus-positive tumor applied to patients in the Phase 2 part of the study only.
    16 Mar 2014
    Amendment 5, Protocol version 6.0 • It was added that overall survival and progression-free survival will be assessed for the Phase 1 part 6 months after the last patient has completed Step 1 of the Phase 1 part.

    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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