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    Clinical Trial Results:
    Randomized, open-label, parallel-group, multi-centre phase II clinical trial with active cellular immunotherapy DCVAC/PCa in combination with hormone therapy in patients with metastatic prostate cancer

    Summary
    EudraCT number
    		 2011-004986-34
    Trial protocol
    		 CZ  
    Global end of trial date
    27 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jul 2017
    First version publication date
    05 Jul 2017
    Other versions
    Summary report(s)
    		 Public Disclosure Summary_SP002_Version 1.0_26-Jan-2017

    Trial information

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    Trial identification
    Sponsor protocol code
    SP002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02107391
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sotio a.s.
    Sponsor organisation address
    Jankovcova 1518/2, Prague, Czech Republic, 170 00
    Public contact
    Clinical Trials Sotio, Sotio a.s., +420 224175111, clinicaltrial@sotio.com
    Scientific contact
    Clinical Trials Sotio, Sotio a.s., +420 224175111, clinicaltrial@sotio.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
    20 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of this clinical trial were to estimate the proportion of patients with PSA and disease progression within 2 years of randomization; to evaluate quality of life and pain scale scoring using the standardized European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30, version 3; and to evaluate the incidence of adverse events (AEs; with the exception of disease progression-related AEs) and overall survival.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 Androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone analogs according to applicable Summaries of Product Characteristics
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Mar 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 7 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 63
    Worldwide total number of subjects
    63
    EEA total number of subjects
    63
    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)
    25
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screened: 74 Randomized: 63 Analyzed for efficacy: 63 Analyzed for safety: 61

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control group
    Arm description
    		 ADT alone
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Immunotherapy group
    Arm description
    		 DCVAC/PCa in combination with ADT
    Arm type
    		 Experimental

    Investigational medicinal product name
    DCVAC/PCa
    Investigational medicinal product code
    Not applicable
    Other name
    Not applicable
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of approximately 1×10e7 autologous dendritic cells

    Number of subjects in period 1
    		Control group Immunotherapy group
    Started
    31
    32
    Completed
    8
    1
    Not completed
    23
    31
         Consent withdrawn by subject
    4
    1
         Disease progression
    16
    25
         Adverse event, non-fatal
    -
    1
         Death due to underlying diease
    2
    2
         Protocol deviation
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 63 63
    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)
    		 25 25
        From 65-84 years
    		 38 38
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 66.5 (40.6 to 80.4) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 63 63
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients

    Subject analysis set title
    PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A subset of the ITT population without patients with a significant protocol deviation and patients who did not undergo any treatment visit

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized patients who underwent at least V1 (control group) or received at least 1 dose of DCVAC/PCa (immunotherapy group)

    Subject analysis sets values
    		 ITT PPS Safety
    Number of subjects
    63
    57
    61
    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)
    25
        From 65-84 years
    38
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    66.5 (40.6 to 80.4)
    Gender categorical
    Units: Subjects
        Female
    0
    0
    0
        Male
    63
    57
    61

    End points

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    End points reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 ADT alone

    Reporting group title
    Immunotherapy group
    Reporting group description
    		 DCVAC/PCa in combination with ADT

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients

    Subject analysis set title
    PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A subset of the ITT population without patients with a significant protocol deviation and patients who did not undergo any treatment visit

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomized patients who underwent at least V1 (control group) or received at least 1 dose of DCVAC/PCa (immunotherapy group)

    Primary: Proportion of patients with PSA progression within 2 years after randomization

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    End point title
    		 Proportion of patients with PSA progression within 2 years after randomization
    End point description
    End point type
    Primary
    End point timeframe
    Within 2 years after randomization
    End point values
    		 Control group Immunotherapy group
    Number of subjects analysed
    31
    32
    Units: Not applicable
        number (confidence interval 95%)
    0.779 (0.599 to 0.917)
    0.939 (0.765 to 0.996)
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    The analysis of the primary endpoint, i.e., the proportion of patients with PSA progression within 2 years after randomization, was based on time to PSA progression.
    Comparison groups
    Control group v Immunotherapy group
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2018
    Method
    		 Logrank
    Confidence interval

    Secondary: Proportion of patients with disease progression within 2 years after randomization

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    End point title
    		 Proportion of patients with disease progression within 2 years after randomization
    End point description
    End point type
    Secondary
    End point timeframe
    Within 2 years after randomization
    End point values
    		 Control group Immunotherapy group
    Number of subjects analysed
    31
    32
    Units: Not applicable
        number (confidence interval 95%)
    0.774 (0.589 to 0.904)
    0.906 (0.75 to 0.98)
    Statistical analysis title
    		 Secondary analysis
    Comparison groups
    Control group v Immunotherapy group
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1836
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Until the end of the study
    End point values
    		 Control group Immunotherapy group
    Number of subjects analysed
    31
    32
    Units: months
        median (confidence interval 95%)
    1000 (24.89 to 1000)
    30.07 (12.85 to 1000)
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    1000 means "not reached"
    Comparison groups
    Control group v Immunotherapy group
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0818
    Method
    		 Logrank
    Confidence interval

    Secondary: Quality of life as per the standardized EORTC QLQ-C30 v3 questionnaire

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    End point title
    		 Quality of life as per the standardized EORTC QLQ-C30 v3 questionnaire
    End point description
    Global health status scale
    End point type
    Secondary
    End point timeframe
    Within 2 years after randomization
    End point values
    		 Control group Immunotherapy group
    Number of subjects analysed
    31
    32
    Units: Not applicable
        arithmetic mean (standard deviation)
    60 ± 25.8
    45.8 ± 21.7
    No statistical analyses for this end point

    Secondary: Pain scale influence scoring as per the standardized EORTC QLQ-C30 v3 questionnaire

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    End point title
    		 Pain scale influence scoring as per the standardized EORTC QLQ-C30 v3 questionnaire
    End point description
    End point type
    Secondary
    End point timeframe
    Within 2 years after randomization
    End point values
    		 Control group Immunotherapy group
    Number of subjects analysed
    31
    32
    Units: Not applicable
        arithmetic mean (standard deviation)
    22.2 ± 34.3
    28.3 ± 30.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent AEs were AEs that started or worsened during the period starting at V1 and ending 30 days after the End of treatment visit.
    Adverse event reporting additional description
    Only treatment-emergent AEs are listed.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 ADT alone

    Reporting group title
    Immunotherapy group
    Reporting group description
    		 DCVAC/PCa in combination with ADT

    Serious adverse events
    		 Control group Immunotherapy group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 30 (10.00%)
    7 / 31 (22.58%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral ischaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord thickening
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary tract obstruction
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Control group Immunotherapy group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 30 (60.00%)
    22 / 31 (70.97%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Oedema peripheral
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    0
    3
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 31 (9.68%)
         occurrences all number
    1
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 30 (10.00%)
    4 / 31 (12.90%)
         occurrences all number
    3
    4
    Arthralgia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Bone pain
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 31 (9.68%)
         occurrences all number
    3
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Dec 2011
    -European Pharminvent Services to be responsible for pharmacovigilance services. -Definition of progression was detailed and consequently was updated secondary endpoint. -Added specification of assessment for leukapheresis technical feasibility (vein access evaluation) prior the procedure for patients in immunotherapy group. -Specification for HIV tests was added (CE marked kits; accredited laboratory).
    07 Jun 2012
    -Prolongation of time period for performance of leukapheresis and for leukapheresis technical feasibility assessment. -Clarification of cyclophosphamide dosing. -Clarification of active cellular immunotherapy dosing. -Inclusion criterion (Inc-3) detailed for soft-tissue metastasis. -Inclusion criterion (Inc-4) detailed for androgen deprivation therapy. -Updated SAE reporting. -Explanation added for not performing leukapheresis in control group. -Screening period prolonged. -Details provided about CT/Scintigraphy readings. -Added criteria for early patient termination in the study. -Active cellular immunotherapy transport and application description updated. -Prolonged sampling period for Immunology and Immunomonitoring to 6 months. -Explanation added that missed active cellular immunotherapy administration is not considered as a reason for termination of patient participation in the trial.
    27 May 2013
    -Deleted the criterion for patient early termination in the study – PSA progression with castrate levels of testosterone.
    05 Feb 2015
    -Detailed description of exploratory objectives, endpoints, and analysis. -Clearly distinguishing IMP from immune enhancers. -Detailed description of laboratory testing performed, including samples for research. - Statistical analysis section updated. -Information about phase I/II clinical trials conducted by University -Hospital in Motol updated per current knowledge. -Section on concomitant medication was updated. -Updated safety reporting sections, including the transfer of safety monitoring responsibilities from European Pharminvent Services to SOTIO a.s. -New term introduction: End of the Treatment, End of Study, End of Study Examination visit, Follow-up, and PSA and Survival Follow-up. -Updated timeline for clinical trial duration. -Updated section Rationale for Prostate Cancer Immunotherapy Terminology harmonization.
    15 Dec 2015
    -Information about study termination clarified -Information about study duration updated -Timing of statistical analysis described -Accord Research s.r.o. appointed for monitoring of PSA and survival follow-up data

    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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