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    Clinical Trial Results:
    An open label Randomised Phase II Trial of RNActive® Cancer Vaccine (CV9104) in high risk and intermediate risk patients with prostate cancer

    Summary
    EudraCT number
    		 2013-004489-32
    Trial protocol
    		 DE  
    Global end of trial date
    12 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Nov 2017
    First version publication date
    18 Nov 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CV-9104-007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CureVac AG
    Sponsor organisation address
    Paul-Ehrlich-Straße 15, Tübingen, Germany, 72076
    Public contact
    Clinical trials Information, CureVac AG, 0049 707198830, info@curevac.com
    Scientific contact
    Clinical trials Information, CureVac AG, 0049 707198830, info@curevac.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
    05 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Apr 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Evaluation of induction of immune responses against 6 tumor antigens encoded by CV9104 administered by conventional intradermal injection or with a needle-free intradermal injection device.
    Protection of trial subjects
    The investigators and all parties involved in this study conducted the study in adherence to the ethical principles based on the Declaration of Helsinki, the German Act on Medical Devices (Medizinproduktegesetz), International Council for Harmonisation (ICH), Good Clinical Practice guidelines, and the applicable national and local laws and regulatory requirements. The investigator ensured that no subject underwent any study-related examination or activity before giving written informed consent to participate in the study. The investigator informed the subject of the objectives, methods, anticipated benefits and potential risks, and inconveniences of the study. The subject was given opportunity to ask for clarification of any points he did not understand and if necessary, ask for more information. At the end of the interview, the subject was given ample time to come to a decision. Insurance coverage for all participating subjects was guaranteed according to applicable legal requirements. Only subjects that met all study inclusion criteria and none of the exclusion criteria were entered in the study. A subject could withdraw his consent to participate in the study at any time without prejudice.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2014
    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
    Germany: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    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)
    17
    From 65 to 84 years
    31
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at 3 centers in Germany. The first subject signed the informed consent form on 23-Jun-2014 and the last subject on 12-Nov-2015. A total of 48 subjects were randomized out of which 46 were evaluable for their immune responder status.

    Pre-assignment
    Screening details
    		 53 subjects were screened, of whom 5 subjects were screening failures because they did not meet the eligibility criteria for the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Subjects in Arm A received 4 administrations of CV9104 with the needle-free intradermal injection device (Tropis®) in Weeks 1, 2, 3, and 5 and underwent radical prostatectomy at least 1 week but not later than 2 weeks after the 4th administration (Week 6 or 7). After surgery, subjects with a confirmed histopathological diagnosis of high risk or very high risk prostate cancer, were offered to receive 2 additional booster administrations of CV9104 starting 8 weeks after surgery (±1 week) with a 2-week interval.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CV9104
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in needle-free injector
    Routes of administration
    Intradermal use
    Dosage and administration details
    Subjects received 4 administrations of CV9104 by needle-free intradermal injection. After radical prostatectomy, subjects with high risk or very high risk prostate cancer, were offered to receive 2 additional administrations of CV9104. One administration with CV9104 included a total of 12 intradermal injections (2 separate injections per individual CV9104 mRNA component) distributed over the 4 limbs (3 injections in each upper arm and thigh). The total dose of CV9104 per administration was 960 µg mRNA with 80 µg mRNA per injection (160 µg per CV9104 mRNA component).

    Arm title
    		 Arm B
    Arm description
    		 Subjects in Arm B received 4 administrations of CV9104 by conventional intradermal injection in Weeks 1, 2, 3, and 5 and underwent radical prostatectomy at least 1 week but not later than 2 weeks after the 4th administration (Week 6 or 7). After surgery, subjects with a confirmed histopathological diagnosis of high risk or very high risk prostate cancer, were offered to receive 2 additional booster administrations of CV9104 starting 8 weeks after surgery (±1 week) with a 2-week interval.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CV9104
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Subjects received 4 administrations of CV9104 by conventional intradermal injection. After radical prostatectomy, subjects with high risk or very high risk prostate cancer, were offered to receive 2 additional administrations of CV9104. One administration with CV9104 included a total of 12 intradermal injections (2 separate injections per individual CV9104 mRNA component) distributed over the 4 limbs (3 injections in each upper arm and thigh). The total dose of CV9104 per administration was 1920 µg mRNA with 160 µg mRNA per injection (320 µg per CV9104 mRNA component).

    Arm title
    		 Arm C
    Arm description
    		 Subjects did not receive any study treatment before the radical prostatectomy. Subjects with histopathologically confirmed high risk or very high risk disease could receive 6 optional administrations of CV9104 (960 µg mRNA per administration) by needle-free intradermal injection with the Tropis® device 8, 9, 10, 12, 14 and 16 weeks after surgery.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Arm A Arm B Arm C
    Started
    15
    17
    16
    Completed
    14
    16
    16
    Not completed
    1
    1
    0
         Consent withdrawn by subject
    1
    -
    -
         Adverse event, non-fatal
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Subjects in Arm A received 4 administrations of CV9104 with the needle-free intradermal injection device (Tropis®) in Weeks 1, 2, 3, and 5 and underwent radical prostatectomy at least 1 week but not later than 2 weeks after the 4th administration (Week 6 or 7). After surgery, subjects with a confirmed histopathological diagnosis of high risk or very high risk prostate cancer, were offered to receive 2 additional booster administrations of CV9104 starting 8 weeks after surgery (±1 week) with a 2-week interval.

    Reporting group title
    Arm B
    Reporting group description
    		 Subjects in Arm B received 4 administrations of CV9104 by conventional intradermal injection in Weeks 1, 2, 3, and 5 and underwent radical prostatectomy at least 1 week but not later than 2 weeks after the 4th administration (Week 6 or 7). After surgery, subjects with a confirmed histopathological diagnosis of high risk or very high risk prostate cancer, were offered to receive 2 additional booster administrations of CV9104 starting 8 weeks after surgery (±1 week) with a 2-week interval.

    Reporting group title
    Arm C
    Reporting group description
    		 Subjects did not receive any study treatment before the radical prostatectomy. Subjects with histopathologically confirmed high risk or very high risk disease could receive 6 optional administrations of CV9104 (960 µg mRNA per administration) by needle-free intradermal injection with the Tropis® device 8, 9, 10, 12, 14 and 16 weeks after surgery.

    Reporting group values
    		 Arm A Arm B Arm C Total
    Number of subjects
    		 15 17 16 48
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 6 8 3 17
        From 65-84 years
    		 9 9 13 31
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.6 ± 6.3 63.8 ± 7 67.5 ± 3 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0 0
        Male
    		 15 17 16 48

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Subjects in Arm A received 4 administrations of CV9104 with the needle-free intradermal injection device (Tropis®) in Weeks 1, 2, 3, and 5 and underwent radical prostatectomy at least 1 week but not later than 2 weeks after the 4th administration (Week 6 or 7). After surgery, subjects with a confirmed histopathological diagnosis of high risk or very high risk prostate cancer, were offered to receive 2 additional booster administrations of CV9104 starting 8 weeks after surgery (±1 week) with a 2-week interval.

    Reporting group title
    Arm B
    Reporting group description
    		 Subjects in Arm B received 4 administrations of CV9104 by conventional intradermal injection in Weeks 1, 2, 3, and 5 and underwent radical prostatectomy at least 1 week but not later than 2 weeks after the 4th administration (Week 6 or 7). After surgery, subjects with a confirmed histopathological diagnosis of high risk or very high risk prostate cancer, were offered to receive 2 additional booster administrations of CV9104 starting 8 weeks after surgery (±1 week) with a 2-week interval.

    Reporting group title
    Arm C
    Reporting group description
    		 Subjects did not receive any study treatment before the radical prostatectomy. Subjects with histopathologically confirmed high risk or very high risk disease could receive 6 optional administrations of CV9104 (960 µg mRNA per administration) by needle-free intradermal injection with the Tropis® device 8, 9, 10, 12, 14 and 16 weeks after surgery.

    Primary: Overall immune responders at any post-baseline time point

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    End point title
    		 Overall immune responders at any post-baseline time point [1]
    End point description
    An overall immune responder (OIR) at any post-baseline time point was a subject being an OIR to at least 1 of the antigens in at least 1 of the analytical methods used (enzyme-linked immunosorbent assay [ELISA], enzyme-linked immunospot assay [ELISpot], intracellular cytokine staining [ICS]) at any of the post-baseline time points (pre-surgical Week [PreS W] or post-surgical Week 8 [PostS W8], but also PreS W and PostS W8).
    End point type
    Primary
    End point timeframe
    Post-baseline time points: 1 week after the 4th CV9104 treatment (before prostatectomy) and 8 weeks after prostatectomy (Arms A and B) or 1 week before and 8 weeks after the prostatectomy (Arm C).
    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: No statistical analysis was planned in the protocol.
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    16
    16
    Units: Subjects
    12
    12
    12
    No statistical analyses for this end point

    Primary: Cellular immune responders at any post-baseline time point

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    End point title
    		 Cellular immune responders at any post-baseline time point [2]
    End point description
    A cellular immune responder (CIR) at any post-baseline time point was a subject being a CIR to at least 1 of the antigens in at least 1 of the analytical methods used for measuring cellular immune responses (ELISpot, ICS) at any of the post-baseline time points (PreS W or PostS W8, but also PreS W and PostS W8).
    End point type
    Primary
    End point timeframe
    Post-baseline time points: 1 week after the 4th CV9104 treatment (before prostatectomy) and 8 weeks after prostatectomy (Arms A and B) or 1 week before and 8 weeks after the prostatectomy (Arm C).
    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: No statistical analysis was planned in the protocol.
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    13
    16
    16
    Units: subjects
    10
    8
    7
    No statistical analyses for this end point

    Primary: Humoral immune responders at any post-baseline time point

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    End point title
    		 Humoral immune responders at any post-baseline time point [3]
    End point description
    A humoral immune responder (HIR) at any post-baseline time point was a subject being an HIR with either antigen specific IgG and/or IgM antibodies to at least 1 of the antigens at any of the post-baseline time points (PreS W or PostS W8, but also PreS W and PostS W8).
    End point type
    Primary
    End point timeframe
    Post-baseline time points: 1 week after the 4th CV9104 treatment (before prostatectomy) and 8 weeks after prostatectomy (Arms A and B) or 1 week before and 8 weeks after the prostatectomy (Arm C).
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned in the protocol.
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    16
    16
    Units: subjects
    3
    7
    7
    No statistical analyses for this end point

    Primary: CD4+ T-cell responders at any post-baseline time point

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    End point title
    		 CD4+ T-cell responders at any post-baseline time point [4]
    End point description
    A CD4+ T-cell responder was a subject considered an immune responder (IR) in the ICS assay measuring CV9104 antigen-specific CD4+ T-cells.
    End point type
    Primary
    End point timeframe
    Post-baseline time points: 1 week after the 4th CV9104 treatment (before prostatectomy) and 8 weeks after prostatectomy (Arms A and B) or 1 week before and 8 weeks after the prostatectomy (Arm C).
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned in the protocol.
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    12
    15
    16
    Units: subjects
    3
    1
    2
    No statistical analyses for this end point

    Primary: CD8+ T-cell responders at any post-baseline time point

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    End point title
    		 CD8+ T-cell responders at any post-baseline time point [5]
    End point description
    A CD8+ T-cell responder was a subject considered an IR in the ICS assay measuring CV9104 antigen-specific CD8+ T-cells.
    End point type
    Primary
    End point timeframe
    Post-baseline time points: 1 week after the 4th CV9104 treatment (before prostatectomy) and 8 weeks after prostatectomy (Arms A and B) or 1 week before and 8 weeks after the prostatectomy (Arm C).
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned in the protocol.
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    12
    15
    16
    Units: subjects
    8
    7
    4
    No statistical analyses for this end point

    Primary: Humoral immune responders with antigen specific IgM antibodies at any post-baseline time point

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    End point title
    		 Humoral immune responders with antigen specific IgM antibodies at any post-baseline time point [6]
    End point description
    A subject being an HIR with antigen specific immunoglobulin M [IgM] antibodies measured via ELISA at any of the post-baseline time points (PreS W or PostS W8, but also PreS W and PostS W8).
    End point type
    Primary
    End point timeframe
    Post-baseline time points: 1 week after the 4th CV9104 treatment (before prostatectomy) and 8 weeks after prostatectomy (Arms A and B) or 1 week before and 8 weeks after the prostatectomy (Arm C).
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned in the protocol.
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    16
    16
    Units: subjects
    3
    4
    1
    No statistical analyses for this end point

    Primary: Humoral immune responders with antigen specific IgG antibodies at any post-baseline time point

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    End point title
    		 Humoral immune responders with antigen specific IgG antibodies at any post-baseline time point [7]
    End point description
    A subject being an HIR with antigen specific immunoglobulin G [IgG] antibodies measured via ELISA at any of the post-baseline time points (PreS W or PostS W8, but also PreS W and PostS W8).
    End point type
    Primary
    End point timeframe
    Post-baseline time points: 1 week after the 4th CV9104 treatment (before prostatectomy) and 8 weeks after prostatectomy (Arms A and B) or 1 week before and 8 weeks after the prostatectomy (Arm C).
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned in the protocol.
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    16
    16
    Units: subjects
    2
    4
    7
    No statistical analyses for this end point

    Secondary: Change in prostate-specific antigen, pre-surgery

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    End point title
    		 Change in prostate-specific antigen, pre-surgery
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Week 1 (Baseline) to Week 6 (Arms A and B) or within 1 week prior to surgery (Arm C). The radical prostatectomy was performed in Weeks 6-7 in Arms A and B and in Weeks 4-7 in Arm C.
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    16
    16
    Units: μg/L
        arithmetic mean (standard deviation)
    0.58 ± 2.771
    0.07 ± 1.332
    -0.44 ± 3.326
    No statistical analyses for this end point

    Secondary: Change in prostate-specific antigen, post-surgery

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    End point title
    		 Change in prostate-specific antigen, post-surgery
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Week 8 post-surgery to End of Study visit.
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    13
    15
    Units: μg/L
        arithmetic mean (standard deviation)
    0.02 ± 0.088
    0.16 ± 0.55
    0.02 ± 0.051
    No statistical analyses for this end point

    Secondary: Number of subjects with treatment-emergent adverse events (TEAEs)

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    End point title
    		 Number of subjects with treatment-emergent adverse events (TEAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    From the date of first CV9104 administration (Arms A and B) or the date of randomization (Arm C) until 28 days after the last CV9104 dose or 12 weeks after surgery (if no CV9104 administered at all or post-surgically)
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    17
    16
    Units: subjects
        Any TEAE
    14
    17
    16
        Pre-surgery TEAEs
    14
    17
    6
        Post-surgery TEAEs
    10
    15
    16
    No statistical analyses for this end point

    Secondary: Number of subjects with related TEAEs

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    End point title
    		 Number of subjects with related TEAEs
    End point description
    End point type
    Secondary
    End point timeframe
    From the date of first CV9104 administration (Arms A and B) or the date of randomization (Arm C) until 28 days after the last CV9104 dose or 12 weeks after surgery (if no CV9104 administered at all or post-surgically)
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    17
    16
    Units: subjects
        CV9104-related TEAEs
    14
    17
    6
        Procedure-related TEAEs
    14
    16
    7
        Device-related TEAEs
    4
    5
    3
        Prostatectomy-related TEAEs
    10
    13
    13
    No statistical analyses for this end point

    Secondary: Number of subjects with TEAEs of CTCAE Grade 3 or higher

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    End point title
    		 Number of subjects with TEAEs of CTCAE Grade 3 or higher
    End point description
    End point type
    Secondary
    End point timeframe
    From the date of first CV9104 administration (Arms A and B) or the date of randomization (Arm C) until 28 days after the last CV9104 dose or 12 weeks after surgery (if no CV9104 administered at all or post-surgically)
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    17
    16
    Units: subjects
        Any TEAE
    3
    5
    3
        CV9104-related TEAEs
    0
    0
    0
        Prostatectomy-related TEAEs
    3
    4
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with treatment-emergent serious adverse events

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    End point title
    		 Number of subjects with treatment-emergent serious adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    From the date of first CV9104 administration (Arms A and B) or the date of randomization (Arm C) until 28 days after the last CV9104 dose or 12 weeks after surgery (if no CV9104 administered at all or post-surgically)
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    17
    16
    Units: subjects
        Any SAE
    2
    3
    5
        Post-surgery SAEs
    2
    3
    5
        Prostatectomy-related SAEs
    2
    3
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with TEAEs leading to permanent discontinuation of study treatment

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    End point title
    		 Number of subjects with TEAEs leading to permanent discontinuation of study treatment
    End point description
    End point type
    Secondary
    End point timeframe
    From the date of first CV9104 administration (Arms A and B) or the date of randomization (Arm C) until 28 days after the last CV9104 dose or 12 weeks after surgery (if no CV9104 administered at all or post-surgically)
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    17
    16
    Units: subjects
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with TEAEs leading to death

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    End point title
    		 Number of subjects with TEAEs leading to death
    End point description
    End point type
    Secondary
    End point timeframe
    From the date of first CV9104 administration (Arms A and B) or the date of randomization (Arm C) until 28 days after the last CV9104 dose or 12 weeks after surgery (if no CV9104 administered at all or post-surgically)
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    17
    16
    Units: subjects
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the date of first CV9104 administration (Arms A and B) or the date of randomization (Arm C) (= treatment-emergent adverse events) until 28 days after the last CV9104 dose or 12 weeks after surgery (if no CV9104 administered at all or post-surgically)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm B
    Reporting group description
    		 -

    Reporting group title
    Arm C
    Reporting group description
    		 -

    Serious adverse events
    		 Arm A Arm B Arm C
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 14 (14.29%)
    3 / 17 (17.65%)
    5 / 16 (31.25%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acral lentiginous melanoma
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    1 / 14 (7.14%)
    3 / 17 (17.65%)
    2 / 16 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm A Arm B Arm C
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    17 / 17 (100.00%)
    15 / 16 (93.75%)
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertension
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Lymphocele
         subjects affected / exposed
    3 / 14 (21.43%)
    4 / 17 (23.53%)
    4 / 16 (25.00%)
         occurrences all number
    3
    6
    5
    Lymphoedema
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Chest pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Chills
         subjects affected / exposed
    0 / 14 (0.00%)
    5 / 17 (29.41%)
    1 / 16 (6.25%)
         occurrences all number
    0
    12
    3
    Extravasation
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 14 (7.14%)
    4 / 17 (23.53%)
    1 / 16 (6.25%)
         occurrences all number
    3
    6
    3
    Influenza like illness
         subjects affected / exposed
    2 / 14 (14.29%)
    8 / 17 (47.06%)
    0 / 16 (0.00%)
         occurrences all number
    6
    18
    0
    Injection site erythema
         subjects affected / exposed
    13 / 14 (92.86%)
    17 / 17 (100.00%)
    6 / 16 (37.50%)
         occurrences all number
    63
    79
    34
    Injection site haemorrhage
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site pain
         subjects affected / exposed
    3 / 14 (21.43%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    7
    4
    2
    Injection site pruritus
         subjects affected / exposed
    1 / 14 (7.14%)
    5 / 17 (29.41%)
    1 / 16 (6.25%)
         occurrences all number
    1
    11
    2
    Local swelling
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Pain
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 14 (0.00%)
    4 / 17 (23.53%)
    2 / 16 (12.50%)
         occurrences all number
    0
    10
    5
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    2 / 14 (14.29%)
    3 / 17 (17.65%)
    6 / 16 (37.50%)
         occurrences all number
    2
    3
    6
    Pelvic pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Testicular pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Testicular swelling
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Obstructive airways disorder
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Blood uric acid increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Prostatic specific antigen increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Dysaesthesia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    3 / 14 (21.43%)
    2 / 17 (11.76%)
    1 / 16 (6.25%)
         occurrences all number
    4
    2
    1
    Hypoaesthesia
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 17 (11.76%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Motor dysfunction
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Asthenopia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 17 (11.76%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Anal fissure
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Constipation
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    4
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 17 (11.76%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Vomiting
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    1
    Hepatobiliary disorders
    Hepatic cyst
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Pruritus generalised
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Urticaria
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Bladder dysfunction
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Dysuria
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Nocturia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    1
    Pollakiuria
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Stress urinary incontinence
         subjects affected / exposed
    7 / 14 (50.00%)
    6 / 17 (35.29%)
    11 / 16 (68.75%)
         occurrences all number
    7
    6
    12
    Urethral pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 17 (11.76%)
    0 / 16 (0.00%)
         occurrences all number
    0
    3
    0
    Back pain
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 17 (17.65%)
    0 / 16 (0.00%)
         occurrences all number
    0
    4
    0
    Groin pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 17 (11.76%)
    2 / 16 (12.50%)
         occurrences all number
    0
    7
    3
    Neck pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 17 (17.65%)
    1 / 16 (6.25%)
         occurrences all number
    0
    5
    1
    Spinal column stenosis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Spinal pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Epididymitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes zoster
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Infected lymphocele
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Oral herpes
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Diabetes mellitus
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Gout
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 17 (5.88%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Feb 2014
    It was added that study treatment was to be permanently discontinued in case of disease progression after radical prostatectomy requiring anti-tumor treatment. Considerations for the sample size estimation were added.
    28 May 2014
    The number of sites was increased from 1 site to approximately 4 sites. Due to the change from a mono-center to a multi-center study, the role of a central pathologist was no longer applicable. Revision of inclusion criterion 2: the requirement for at least 3 biopsies with confirmed adenocarcinoma with at least 50% tumor infiltration in at least 1 biopsy was removed. To allow for a more exact localization of the tumor, optional magnetic-resonance imaging assessment was included. Dipstick as method for the urinalysis was removed to allow the use of different methods. It was clarified that only those serious adverse events (SAEs) were to be reported to the sponsor after end of the observation period that were considered related by the investigator.
    18 Jul 2014
    Revision of inclusion criterion 2: the restriction for subjects to have only 1 criterion for high risk disease (Gleason score of 8-10, a serum PSA <20 ng/mL or cT3a without tumor fixation to adjacent organs) was removed. It was clarified that in case no study medication was administered to a subject, the observation period for adverse events (AEs) was to last until 12 weeks after surgery. The handling and follow-up of AEs after the end of study visit was described in more detail.
    24 Feb 2015
    Revision of the primary endpoint: The definition of the primary endpoint was extended to include humoral immune response rates against all RNActive® encoded antigens. Humoral immune response rates were to be measured against all 6 RNActive®-encoded antigens and not only against 4 of 6 antigens; however ultimately, humoral immune response could only be measured for 4 of the 6 antigens. Blood sampling for HLA-class I and II antigen testing was added for completeness. The reporting requirements of SAEs in regard to the medical device were revised. The definition of the safety analysis set was revised to allow the inclusion of subjects in Arm C.
    06 Jul 2015
    Enrolled subjects diagnosed with very high risk prostate cancer after surgery (based on histopathological assessment) were allowed to receive post-surgical administrations of CV9104. It was clarified that the administration of CV9104 was to be completed before the initiation of adjuvant or salvage radiotherapy. It was clarified that if time windows for post-surgical administrations of CV9104 were missed, the respective administration was to be skipped and the next administration was to be performed as scheduled.

    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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