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    Clinical Trial Results:
    Bevacizumab, Interleukin-2 and Interferon-alpha in metastathic renal cell carcinoma

    Summary
    EudraCT number
    		 2009-012010-52
    Trial protocol
    		 DK  
    Global end of trial date
    31 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Dec 2020
    First version publication date
    03 Dec 2020
    Other versions
    Summary report(s)
    		 DaRenCa study-1

    Trial information

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    Trial identification
    Sponsor protocol code
    mRCC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01274273
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University
    Sponsor organisation address
    Noerrebrogade 44, Aarhus, Denmark,
    Public contact
    Frede Donskov, Aarhus University Hospital, +45 27147015, fd@oncology.au.dk
    Scientific contact
    Frede Donskov, Aarhus University Hospital, +45 27147015, fd@oncology.au.dk
    Sponsor organisation name
    Department of Oncology, Aarhus University Hospital
    Sponsor organisation address
    Noerrebrogade 44, Aarhus, Denmark,
    Public contact
    Frede Donskov , Aarhus university hospital, +45 27147015, fd@oncology.au.dk
    Scientific contact
    Frede Donskov , Aarhus university hospital, +45 27147015, fd@oncology.au.dk
    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
    31 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Avastin as monotherapy has effect in mRCC. Avastin in combination with interferon-alfa (IFN-α) has significant efficacy in mRCC and has been approved by EMEA. The present study assessed whether the combination of Interleukin-2 (IL-2) and IFN-α with Avastin may add efficacy in patients with mRCC with a tolerable safety profile. Primary endpoint: Progression Free Survival
    Protection of trial subjects
    No specific measures
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Oct 2009
    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
    Denmark: 118
    Worldwide total number of subjects
    118
    EEA total number of subjects
    118
    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)
    98
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 N/A

    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
    		 IL2/INF/BEV2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    bevacizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/kg IV

    Arm title
    		 IL2/INF
    Arm description
    		 -
    Arm type
    		 Standard therapy

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		IL2/INF/BEV2 IL2/INF
    Started
    59
    59
    Completed
    59
    59

    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
    		 118 118
    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)
    		 116 116
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 57 (28 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 25 25
        Male
    		 93 93
    IMDC
    IMDC risk classification
    Units: Subjects
        Favorable
    		 26 26
        Intermediate
    		 68 68
        Poor
    		 24 24
    Karnofsky PS
    Karnofsky PS
    Units: Subjects
        100
    		 68 68
        90
    		 35 35
        80
    		 10 10
        70
    		 5 5
    MSKCC risk
    MSKCC risk classification
    Units: Subjects
        Favorable
    		 61 61
        intermediate
    		 57 57
    Metastasis -free interval
    Units: Subjects
        < 1 year
    		 88 88
        >1
    		 30 30
    Nephrectomy
    Units: Subjects
        yes
    		 101 101
        No
    		 17 17
    Subject analysis sets

    Subject analysis set title
    IL2/IFN/BEV
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients treated with IL2/IFN/BEV

    Subject analysis set title
    IL2/INF
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients treated with IL2/INF

    Subject analysis sets values
    		 IL2/IFN/BEV IL2/INF
    Number of subjects
    59
    59
    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)
    58
    58
        From 65-84 years
    1
    1
        85 years and over
    0
    0
    Age continuous
    Units: years
        median (full range (min-max))
    58 (28 to 70)
    55 (37 to 69)
    Gender categorical
    Units: Subjects
        Female
    13
    12
        Male
    46
    47
    IMDC
    IMDC risk classification
    Units: Subjects
        Favorable
    14
    12
        Intermediate
    32
    36
        Poor
    13
    11
    Karnofsky PS
    Karnofsky PS
    Units: Subjects
        100
    31
    37
        90
    19
    16
        80
    6
    4
        70
    3
    2
    MSKCC risk
    MSKCC risk classification
    Units: Subjects
        Favorable
    30
    31
        intermediate
    29
    28
    Metastasis -free interval
    Units: Subjects
        < 1 year
    43
    45
        >1
    16
    14
    Nephrectomy
    Units: Subjects
        yes
    50
    51
        No
    9
    8

    End points

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    End points reporting groups
    Reporting group title
    IL2/INF/BEV2
    Reporting group description
    		 -

    Reporting group title
    IL2/INF
    Reporting group description
    		 -

    Subject analysis set title
    IL2/IFN/BEV
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients treated with IL2/IFN/BEV

    Subject analysis set title
    IL2/INF
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients treated with IL2/INF

    Primary: Progression free survival (PFS)

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    End point title
    		 Progression free survival (PFS)
    End point description
    End point type
    Primary
    End point timeframe
    Response evaluation (according to RECIST 1.1) every 12th week until week 104. Hereafter every 24th week until disease progression
    End point values
    		 IL2/INF/BEV2 IL2/INF
    Number of subjects analysed
    59
    59
    Units: months
        median (confidence interval 95%)
    8.0 (4.2 to 11.9)
    8.1 (5.1 to 11.0)
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    IL2/INF/BEV2 v IL2/INF
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 5
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Statistical analysis title
    		 Efficacy analysis
    Statistical analysis description
    Differences in progression free survival in the two treatment arms will be tested with a two-sided log rank test at the 5% alpha level. Kaplan Meier curves will be displayed, with median progression free survival estimates and confidence limits given.
    Comparison groups
    IL2/INF/BEV2 v IL2/INF
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 5
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Response evaluation (according to RECIST 1.1) every 12th week until week 104. Hereafter every 24th week until disease progression or death
    End point values
    		 IL2/INF/BEV2 IL2/INF
    Number of subjects analysed
    59
    59
    Units: Months
        median (confidence interval 95%)
    30.3 (20.6 to 40.0)
    34.1 (19.9 to 48.2)
    No statistical analyses for this end point

    Secondary: Objective respons rate (ORR)

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    End point title
    		 Objective respons rate (ORR)
    End point description
    End point type
    Secondary
    End point timeframe
    Response evaluation (according to RECIST 1.1) every 12th week until week 104. Hereafter every 24th week until disease progression
    End point values
    		 IL2/INF/BEV2 IL2/INF
    Number of subjects analysed
    59
    59
    Units: Rate
    44
    29
    No statistical analyses for this end point

    Secondary: Time-to-treatment failure (TTF)

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    End point title
    		 Time-to-treatment failure (TTF)
    End point description
    End point type
    Secondary
    End point timeframe
    Response evaluation (according to RECIST 1.1) every 12th week until week 104. Hereafter every 24th week until disease progression
    End point values
    		 IL2/INF/BEV2 IL2/INF
    Number of subjects analysed
    59
    59
    Units: months
        median (confidence interval 95%)
    7.4 (4.4 to 10.3)
    5.6 (2.6 to 8.5)
    No statistical analyses for this end point

    Secondary: Frequency of no evidence of disease (NED)

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    End point title
    		 Frequency of no evidence of disease (NED)
    End point description
    End point type
    Secondary
    End point timeframe
    Response evaluation (according to RECIST 1.1) every 12th week until week 104. Hereafter every 24th week until disease progression
    End point values
    		 IL2/INF/BEV2 IL2/INF
    Number of subjects analysed
    59
    59
    Units: patients
    3
    9
    No statistical analyses for this end point

    Secondary: Frequency of surgical residual disease

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    End point title
    		 Frequency of surgical residual disease
    End point description
    End point type
    Secondary
    End point timeframe
    Response evaluation (according to RECIST 1.1) every 12th week until week 104. Hereafter every 24th week until disease progression
    End point values
    		 IL2/INF/BEV2 IL2/INF
    Number of subjects analysed
    59
    59
    Units: patients
    17
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event was reported during the clinical study as per protocol
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    current
    Reporting groups
    Reporting group title
    IL2/IFN/BEV
    Reporting group description
    		 Experimental arm

    Reporting group title
    IL2/IFN-alfa
    Reporting group description
    		 Control arm

    Serious adverse events
    		 IL2/IFN/BEV IL2/IFN-alfa
    Total subjects affected by serious adverse events
         subjects affected / exposed
    50 / 59 (84.75%)
    49 / 59 (83.05%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Weight decrease neonatal
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    15 / 59 (25.42%)
    2 / 59 (3.39%)
         occurrences causally related to treatment / all
    15 / 15
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypotension
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thrombosis
         subjects affected / exposed
    4 / 59 (6.78%)
    11 / 59 (18.64%)
         occurrences causally related to treatment / all
    4 / 4
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    38 / 59 (64.41%)
    36 / 59 (61.02%)
         occurrences causally related to treatment / all
    38 / 38
    36 / 36
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    flu like symptoms
         subjects affected / exposed
    22 / 59 (37.29%)
    24 / 59 (40.68%)
         occurrences causally related to treatment / all
    22 / 22
    24 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 59 (8.47%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    5 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 59 (5.08%)
    4 / 59 (6.78%)
         occurrences causally related to treatment / all
    3 / 3
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vomiting
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 59 (0.00%)
    3 / 59 (5.08%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    3 / 59 (5.08%)
    3 / 59 (5.08%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    confusion
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    15 / 59 (25.42%)
    15 / 59 (25.42%)
         occurrences causally related to treatment / all
    15 / 15
    15 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IL2/IFN/BEV IL2/IFN-alfa
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    59 / 59 (100.00%)
    59 / 59 (100.00%)
    Investigations
    Weight decreased
         subjects affected / exposed
    33 / 59 (55.93%)
    38 / 59 (64.41%)
         occurrences all number
    33
    38
    Vascular disorders
    Hypertension
         subjects affected / exposed
    17 / 59 (28.81%)
    8 / 59 (13.56%)
         occurrences all number
    17
    8
    Hypotension
         subjects affected / exposed
    10 / 59 (16.95%)
    5 / 59 (8.47%)
         occurrences all number
    10
    5
    Thrombosis
         subjects affected / exposed
    4 / 59 (6.78%)
    11 / 59 (18.64%)
         occurrences all number
    4
    11
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    19 / 59 (32.20%)
    20 / 59 (33.90%)
         occurrences all number
    19
    20
    flu like symptoms
         subjects affected / exposed
    34 / 59 (57.63%)
    31 / 59 (52.54%)
         occurrences all number
    34
    31
    Injection site reaction
         subjects affected / exposed
    34 / 59 (57.63%)
    40 / 59 (67.80%)
         occurrences all number
    34
    40
    Gastrointestinal disorders
    Diarrhea
    Additional description: No new or unexpected toxicity was observed
         subjects affected / exposed
    33 / 59 (55.93%)
    42 / 59 (71.19%)
         occurrences all number
    33
    42
    Nausea
         subjects affected / exposed
    50 / 59 (84.75%)
    48 / 59 (81.36%)
         occurrences all number
    50
    48
    Vomiting
         subjects affected / exposed
    31 / 59 (52.54%)
    33 / 59 (55.93%)
         occurrences all number
    31
    33
    Dyspepsia
         subjects affected / exposed
    7 / 59 (11.86%)
    18 / 59 (30.51%)
         occurrences all number
    7
    18
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 59 (18.64%)
    12 / 59 (20.34%)
         occurrences all number
    11
    12
    Dyspnoea
         subjects affected / exposed
    24 / 59 (40.68%)
    18 / 59 (30.51%)
         occurrences all number
    24
    18
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    25 / 59 (42.37%)
    20 / 59 (33.90%)
         occurrences all number
    25
    20
    Dry skin
         subjects affected / exposed
    42 / 59 (71.19%)
    48 / 59 (81.36%)
         occurrences all number
    42
    48
    Rash
         subjects affected / exposed
    11 / 59 (18.64%)
    6 / 59 (10.17%)
         occurrences all number
    11
    6
    Pruritus
         subjects affected / exposed
    50 / 59 (84.75%)
    35 / 59 (59.32%)
         occurrences all number
    50
    35
    Psychiatric disorders
    confusion
         subjects affected / exposed
    14 / 59 (23.73%)
    17 / 59 (28.81%)
         occurrences all number
    14
    17
    Depression
         subjects affected / exposed
    19 / 59 (32.20%)
    15 / 59 (25.42%)
         occurrences all number
    19
    15
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    7 / 59 (11.86%)
    0 / 59 (0.00%)
         occurrences all number
    7
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    10 / 59 (16.95%)
    1 / 59 (1.69%)
         occurrences all number
    10
    1
    Infections and infestations
    Stomatitis
         subjects affected / exposed
    19 / 59 (32.20%)
    10 / 59 (16.95%)
         occurrences all number
    19
    10
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    10 / 59 (16.95%)
    8 / 59 (13.56%)
         occurrences all number
    10
    8

    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
    For support, Contact us.
    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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