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    Clinical Trial Results:
    Phase II study of Avelumab in multiple relapsed/refractory testicular germ cell cancer.

    Summary
    EudraCT number
    		 2016-004632-38
    Trial protocol
    		 SK  
    Global end of trial date
    09 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Sep 2021
    First version publication date
    04 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GCTSK005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03403777
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Národný onkologický ústav
    Sponsor organisation address
    Klenova 1, Bratislava, Slovakia, 83310
    Public contact
    Oddelenie klinických skúšaní, Národný onkologický ústav, 00421 259378592, daniela.svetlovska@nou.sk
    Scientific contact
    Oddelenie klinických skúšaní, Národný onkologický ústav, 00421 259378592, daniela.svetlovska@nou.sk
    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
    28 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    09 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy (as measured by 12-week progression-free survival) of AVELUMAB in patients with multiple relapsed/refractory germ cell tumors.
    Protection of trial subjects
    All the procedures performed in study involving human participants were conducted in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    13 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Enrollment started from 13.11.2017 to 23.1.2019, 8 patients were enrolled.

    Pre-assignment
    Screening details
    		 Relapsed/refractory testicular germ cell cancer.

    Pre-assignment period milestones
    Number of subjects started
    		 8
    Number of subjects completed
    		 8

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Avelumab
    Arm description
    		 Subjects intravenously received 10 mg/kg of Avelumab every two weeks until progression or unacceptable toxicity or other reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Avelumab
    Investigational medicinal product code
    MSB0010718C
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10mg/kg every 2 weeks

    Number of subjects in period 1
    		Avelumab
    Started
    8
    Completed
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study (overall period) Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Avelumab
    Reporting group description
    		 Subjects intravenously received 10 mg/kg of Avelumab every two weeks until progression or unacceptable toxicity or other reason.

    Subject analysis set title
    Overall study
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Single arm trial

    Primary: 12-week progression-free survival rate

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    End point title
    		 12-week progression-free survival rate
    End point description
    Twelve-week PFS in the first 8 patients was 0%, therefore the study was terminated because of futility.
    End point type
    Primary
    End point timeframe
    12-week progression free survival rate was defined as number of living patients without progression after 12-week of start of study treatment.
    End point values
    		 Avelumab Overall study
    Number of subjects analysed
    8
    8
    Units: number of patients
    0
    0
    Statistical analysis title
    		 description statistics
    Comparison groups
    Avelumab v Overall study
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 5
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [1] - 8 patients were analysed, subject in analyses 16 is number doubling automatically by the system

    Secondary: Response rate

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    End point title
    		 Response rate
    End point description
    None of the enrolled patients had partial or complete response to the study treatment.
    End point type
    Secondary
    End point timeframe
    Objective response rate is defined as sum of complete and partial responses. It is defined from start of the treatment until progression of disease or start of new anticancer treatment.
    End point values
    		 Avelumab
    Number of subjects analysed
    8
    Units: number of patients
    0
    No statistical analyses for this end point

    Secondary: overall survival

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    End point title
    		 overall survival
    End point description
    Median OS was 2.7 months, 95% CI (1.0 – 3.3).
    End point type
    Secondary
    End point timeframe
    Overall survival was calculated from the beginning of treatment untill death from any cause on intention-to-treat basis.
    End point values
    		 Avelumab
    Number of subjects analysed
    8
    Units: month
        median (confidence interval 95%)
    2.7 (1.0 to 3.3)
    No statistical analyses for this end point

    Secondary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    Median PFS was 0.9 months, 95%CI (0.5 – 1.9)
    End point type
    Secondary
    End point timeframe
    Progression-free survival was calculated from the beginning of the treatment until progression or death from disease-specific cause on intention-to-treat basis.
    End point values
    		 Avelumab
    Number of subjects analysed
    8
    Units: month
        median (confidence interval 95%)
    0.9 (0.5 to 1.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded from start of study treatment until 28 days after study treatment discontinuation.
    Adverse event reporting additional description
    7 patients experienced any AE grade 1-3, none of the patients experienced grade 4-5 AE. Also none of the patients experienced SAE. Secondary end point was grade 3/4 toxicity, grade 3 toxicity experienced 5 patients, grade 4 none of the patients.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Avelumab
    Reporting group description
    		 7 patients from 8 experienced adverse events from grade 1 to grade 3. None of patients experienced grade 4 or 5 adverse events. None of the patients experienced SAE.

    Serious adverse events
    		 Avelumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
         number of deaths (all causes)
    7
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Avelumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 8 (87.50%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumor pain
    Additional description: Grade 3 tumor pain experienced 3 patients. None patient experienced grade 4. Only grade 3/4 are reported.
         subjects affected / exposed
    3 / 8 (37.50%)
         occurrences all number
    3
    Cachexia
    Additional description: Grade 3 cachexia experienced 1 patient. None patient experienced grade 4. Only grade 3/4 are reported.
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Investigations
    Platelet count decreased
    Additional description: Grade 3 platelet count decreased experienced 1 patient. None patient experienced grade 4. Only grade 3/4 are reported.
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anemia
    Additional description: Grade 3 anemia experienced 1 patient. None patient experienced grade 4. Only grade 3/4 are reported.
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
    Additional description: Grade 3 fatigue experienced 1 patient. None patient experienced grade 4. Only grade 3/4 are reported.
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
    Additional description: Grade 3 dyspnea experienced 1 patient. None patient experienced grade 4. Only grade 3/4 are reported.
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Renal and urinary disorders
    Urinary retention
    Additional description: 1 patient experienced urinary retention grade 3. None patient experienced grade 4. Only grade 3/4 are reported.
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypoalbuminemia
    Additional description: Grade 3 hypoalbuminemia experienced 1 patient. None patient experienced grade 4. Only grade 3/4 are reported.
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31152292
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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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