Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomized, controlled Phase III study investigating IMA901 multipeptide cancer vaccine in patients receiving sunitinib as first-line therapy for advanced/metastatic renal cell carcinoma

    Summary
    EudraCT number
    		 2010-022459-45
    Trial protocol
    		 DE   HU   GB   NL   IT  
    Global end of trial date
    28 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jan 2019
    First version publication date
    23 Jan 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IMA901-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01265901
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Immatics Biotechnologies GmbH
    Sponsor organisation address
    Paul-Ehrlich-Str. 15, Tübingen, Germany, 72076
    Public contact
    Reception, Immatics Biotechnologies GmbH, +49 707153970, info@immatics.com
    Scientific contact
    Reception, Immatics Biotechnologies GmbH, +49 707153970, info@immatics.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
    10 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the present phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with sunitinib
    Protection of trial subjects
    This study was conducted in compliance with local legal and regulatory requirements and in conformance with Good Clinical Practice standards. All subjects were fully informed about nature, scope and possible consequences of the clinical trial in a language appropriate for the subject.
    Background therapy
    		 sunitinib as first-line therapy for advanced/metastatic renal cell carcinoma
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Dec 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    Poland: 64
    Country: Number of subjects enrolled
    United Kingdom: 18
    Country: Number of subjects enrolled
    France: 26
    Country: Number of subjects enrolled
    Germany: 29
    Country: Number of subjects enrolled
    Hungary: 30
    Country: Number of subjects enrolled
    Italy: 16
    Country: Number of subjects enrolled
    Russian Federation: 113
    Country: Number of subjects enrolled
    Romania: 9
    Country: Number of subjects enrolled
    United States: 32
    Worldwide total number of subjects
    339
    EEA total number of subjects
    194
    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)
    212
    From 65 to 84 years
    127
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Between Dec 22, 2010, and Dec 15, 2012 1171 patients were screened at 124 clinical sites in Germany, France, Italy, the Netherlands, Norway, UK, Hungary, Poland, Russia, Romania, and USA, of whom 339 were randomly assigned to receive sunitinib plus IMA901 (n=204) or sunitinib monotherapy (n=135).

    Pre-assignment
    Screening details
    		 The following steps were performed before randomization: check for inclusion/exclusion criteria, eligibility for first-line therapy with sunitinib, contraindications, medical history of the subjects and signing informed consent forms.

    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
    		 sunitinib plus IMA901
    Arm description
    		 Patients randomized to the vaccination arm (Arm 1) received a total of 10 vaccinations with IMA901 + GM-CSF (Visits 1 to 10) in addition to sunitinib during the vaccination period (length of approximately 4 months). Pre-treatment with Cyclophosphamide was given to all patients in Arm 1 three days before first vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IMA901
    Investigational medicinal product code
    IMA901
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    IMA901 was administered intradermal with a dose of 4,13 mg at each vaccination.

    Investigational medicinal product name
    Leukine
    Investigational medicinal product code
    GM-CSF
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    GM-CSF was given intradermally with a dose of 75 μg shortly before the vaccination with IMA901.

    Investigational medicinal product name
    Endoxan
    Investigational medicinal product code
    Cyclophosphamide
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cyclophosphamide was given 3 days before the first vaccination with a dose of 300mg/m² BSA intravenously

    Investigational medicinal product name
    Sutent
    Investigational medicinal product code
    Sunitinib
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Sunitinib was given 50 mg orally once daily, with a complete sunitinib cycle defined as 4 weeks on treatment followed by 2 weeks off treatment

    Arm title
    		 sunitinib
    Arm description
    		 Patients randomized to the control arm (Arm 2) received a sunitinib montherapy.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    sutent
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Sunitinib was given 50 mg orally once daily, with a complete sunitinib cycle defined as 4 weeks on treatment followed by 2 weeks off treatment

    Number of subjects in period 1
    		sunitinib plus IMA901 sunitinib
    Started
    204
    135
    Completed
    185
    130
    Not completed
    19
    5
         did not receive cyclophosphamide
    3
    -
         Consent withdrawn by subject
    12
    2
         other reasons
    4
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    sunitinib plus IMA901
    Reporting group description
    		 Patients randomized to the vaccination arm (Arm 1) received a total of 10 vaccinations with IMA901 + GM-CSF (Visits 1 to 10) in addition to sunitinib during the vaccination period (length of approximately 4 months). Pre-treatment with Cyclophosphamide was given to all patients in Arm 1 three days before first vaccination.

    Reporting group title
    sunitinib
    Reporting group description
    		 Patients randomized to the control arm (Arm 2) received a sunitinib montherapy.

    Reporting group values
    		 sunitinib plus IMA901 sunitinib Total
    Number of subjects
    		 204 135 339
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.2 ( 8.9 ) 59.8 ( 9.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 62 47 109
        Male
    		 142 88 230
    Karnofsky Performance Status
    Units: Subjects
        60-70%
    		 0 3 3
        80-90%
    		 112 64 176
        100%
    		 92 68 160
    Risk group (Heng)
    Units: Subjects
        Favorable
    		 56 35 91
        Intermediate
    		 145 96 241
        Poor
    		 3 4 7
    Nephrectomy
    Units: Subjects
        Yes
    		 183 123 306
        No
    		 21 12 33
    Region
    Units: Subjects
        Western Europe
    		 55 36 91
        Central and Eastern Europe
    		 128 88 216
        United States
    		 21 11 32
    Body-mass index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.6 ( 4.8 ) 28.2 ( 4.6 ) -
    Subject analysis sets

    Subject analysis set title
    Biomarker-positive subgroup 1 (BP-1) in ARM1
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    patients treated with suntinib plus IMA901 with at least one positive biomarker [APOA1 and/or CCL17]

    Subject analysis set title
    Biomarker-positive subgroup 1 (BP-1) in ARM2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    patients treated with sunitinib (ARM1) with at least one positive biomarker [APOA1 and/or CCL17]

    Subject analysis set title
    Class I immune Responder
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with Response to at least one Class I TUMAP in the sunitinib plus IMA901 group (ARM1) analysed for immune responses to the peptides contained in IMA901

    Subject analysis set title
    Class I immune Non-responder
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with no response to any Class I TUMAP in the sunitinib plus IMA901 group (ARM1) analysed for immune responses to the peptides contained in IMA901

    Subject analysis set title
    Class I multi-peptide Responder
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with Response to ≥2 Class I TUMAPs in the sunitinib plus IMA901 group (ARM1) analysed for immune responses to the peptides contained in IMA901

    Subject analysis set title
    Class I multi-peptide response Non-responder
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with Response to ≤ 1 Class I TUMAP in the sunitinib plus IMA901 group (ARM1) analysed for immune responses to the peptides contained in IMA901

    Subject analysis set title
    Safety Population Main Phase in ARM1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    patients randomized to ARM1 to receive sunitinib plus IMA901 having completed Visit D.

    Subject analysis set title
    Safety Population Main Phase in ARM2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    all patients randomized to ARM2 to receive sunitinib having completed Visit D.

    Subject analysis sets values
    		 Biomarker-positive subgroup 1 (BP-1) in ARM1 Biomarker-positive subgroup 1 (BP-1) in ARM2 Class I immune Responder Class I immune Non-responder Class I multi-peptide Responder Class I multi-peptide response Non-responder Safety Population Main Phase in ARM1 Safety Population Main Phase in ARM2
    Number of subjects
    134
    95
    51
    45
    16
    80
    202
    132
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    Karnofsky Performance Status
    Units: Subjects
        60-70%
    2
    0
    0
    0
    0
    0
    2
        80-90%
    70
    44
    23
    26
    10
    39
    110
    62
        100%
    64
    48
    28
    19
    6
    41
    92
    68
    Risk group (Heng)
    Units: Subjects
        Favorable
        Intermediate
        Poor
    Nephrectomy
    Units: Subjects
        Yes
        No
    Region
    Units: Subjects
        Western Europe
        Central and Eastern Europe
        United States
    Body-mass index
    Units: kg/m2
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    sunitinib plus IMA901
    Reporting group description
    		 Patients randomized to the vaccination arm (Arm 1) received a total of 10 vaccinations with IMA901 + GM-CSF (Visits 1 to 10) in addition to sunitinib during the vaccination period (length of approximately 4 months). Pre-treatment with Cyclophosphamide was given to all patients in Arm 1 three days before first vaccination.

    Reporting group title
    sunitinib
    Reporting group description
    		 Patients randomized to the control arm (Arm 2) received a sunitinib montherapy.

    Subject analysis set title
    Biomarker-positive subgroup 1 (BP-1) in ARM1
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    patients treated with suntinib plus IMA901 with at least one positive biomarker [APOA1 and/or CCL17]

    Subject analysis set title
    Biomarker-positive subgroup 1 (BP-1) in ARM2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    patients treated with sunitinib (ARM1) with at least one positive biomarker [APOA1 and/or CCL17]

    Subject analysis set title
    Class I immune Responder
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with Response to at least one Class I TUMAP in the sunitinib plus IMA901 group (ARM1) analysed for immune responses to the peptides contained in IMA901

    Subject analysis set title
    Class I immune Non-responder
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with no response to any Class I TUMAP in the sunitinib plus IMA901 group (ARM1) analysed for immune responses to the peptides contained in IMA901

    Subject analysis set title
    Class I multi-peptide Responder
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with Response to ≥2 Class I TUMAPs in the sunitinib plus IMA901 group (ARM1) analysed for immune responses to the peptides contained in IMA901

    Subject analysis set title
    Class I multi-peptide response Non-responder
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with Response to ≤ 1 Class I TUMAP in the sunitinib plus IMA901 group (ARM1) analysed for immune responses to the peptides contained in IMA901

    Subject analysis set title
    Safety Population Main Phase in ARM1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    patients randomized to ARM1 to receive sunitinib plus IMA901 having completed Visit D.

    Subject analysis set title
    Safety Population Main Phase in ARM2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    all patients randomized to ARM2 to receive sunitinib having completed Visit D.

    Primary: Overall Survival

    		 Close Top of page
    End point title
    		 Overall Survival
    End point description
    based on Kaplan-Meier estimates; cut-off date: 12-MAR-2015 ['99999'' indicates that data was not available as respective median and upper limit of 95% confidence interval could not be determined.]
    End point type
    Primary
    End point timeframe
    Overall Survival from randomization to death
    End point values
    		 sunitinib plus IMA901 sunitinib
    Number of subjects analysed
    204
    135
    Units: days
        median (confidence interval 95%)
    1009 (846 to 1258)
    99999 (1024 to 99999)
    Statistical analysis title
    		 Analysis of Primary Endpoint
    Statistical analysis description
    The primary endpoint is to evaluate Overall Survival, comparing patients receiving or not vaccination therapy with IMA901 in addition to first-line therapy with sunitinib. Comparision of both treatmetn arms was performed on basis of Kaplan-Meier estimates
    Comparison groups
    sunitinib plus IMA901 v sunitinib
    Number of subjects included in analysis
    339
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0784
    Method
    		 Logrank
    Confidence interval

    Secondary: Overall survival by biomarker subgroup

    		 Close Top of page
    End point title
    		 Overall survival by biomarker subgroup
    End point description
    based on Kaplan-Meier estimates; cut-off date: 12-MAR-2015 ['99999'' indicates that data was not available as respective median and upper limit of 95% confidence interval could not be determined.]
    End point type
    Secondary
    End point timeframe
    Overall survival measured from randomization until death.
    End point values
    		 Biomarker-positive subgroup 1 (BP-1) in ARM1 Biomarker-positive subgroup 1 (BP-1) in ARM2
    Number of subjects analysed
    134
    95
    Units: days
        median (confidence interval 95%)
    1258 (922 to 1258)
    99999 (1024 to 99999)
    Statistical analysis title
    		 Overall survival by Biomarker-positive subgroup
    Statistical analysis description
    Secondary endpoint is to evaulaute overall survival in patients who are positive for the prospectively defined primary biomarker signature (identified as being predictive for improved clinical outcome in IMA901-vaccinated patients in the previous phase II study).
    Comparison groups
    Biomarker-positive subgroup 1 (BP-1) in ARM1 v Biomarker-positive subgroup 1 (BP-1) in ARM2
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5104
    Method
    		 Logrank
    Confidence interval

    Secondary: Progression-free Survival (until EOS)

    		 Close Top of page
    End point title
    		 Progression-free Survival (until EOS)
    End point description
    Progression-free survival (PFS) using RECIST 1.1, based on the centrally reviewed tumor images.
    End point type
    Secondary
    End point timeframe
    Progression-free survival (PFS) is defined as the time from randomization to documented progression or death (until EOS)
    End point values
    		 sunitinib plus IMA901 sunitinib
    Number of subjects analysed
    204
    135
    Units: days
        median (confidence interval 95%)
    463 (379 to 550)
    460 (310 to 565)
    Statistical analysis title
    		 Analysis of Secondary Endpoint PFS
    Comparison groups
    sunitinib plus IMA901 v sunitinib
    Number of subjects included in analysis
    339
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.618
    Method
    		 Logrank
    Confidence interval
    Notes
    [1] - Survival Analysis of PFS based on Kaplan-Meier estimates

    Secondary: Progression-free survival including the first 3 months of OS follow-up

    		 Close Top of page
    End point title
    		 Progression-free survival including the first 3 months of OS follow-up
    End point description
    Progression-free survival (PFS) using RECIST 1.1, based on the centrally reviewed tumor images.
    End point type
    Secondary
    End point timeframe
    Progression-free survival (PFS) is defined as the time from randomization to documented progression or death including the first 3 months of survival follow-up.
    End point values
    		 sunitinib plus IMA901 sunitinib
    Number of subjects analysed
    204
    135
    Units: days
        median (confidence interval 95%)
    449 (352 to 518)
    460 (305 to 565)
    Statistical analysis title
    		 Analysis of Secondary Endpoint PFS
    Comparison groups
    sunitinib plus IMA901 v sunitinib
    Number of subjects included in analysis
    339
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.423
    Method
    		 Logrank
    Confidence interval

    Secondary: Progression-free survival (counted from start of sunitinib treatment) until EOS

    		 Close Top of page
    End point title
    		 Progression-free survival (counted from start of sunitinib treatment) until EOS
    End point description
    Progression-free survival (PFS) using RECIST 1.1, based on the centrally reviewed tumor images.
    End point type
    Secondary
    End point timeframe
    Progression-free survival (PFS) is defined as the time from start of sunitinib first-line treatment to documented progression or death (until EOS)
    End point values
    		 sunitinib plus IMA901 sunitinib
    Number of subjects analysed
    204
    135
    Units: days
        median (confidence interval 95%)
    492 (408 to 577)
    490 (341 to 587)
    Statistical analysis title
    		 Analysis of Secondary Endpoint PFS
    Comparison groups
    sunitinib plus IMA901 v sunitinib
    Number of subjects included in analysis
    339
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.698
    Method
    		 Logrank
    Confidence interval

    Secondary: Overall survival by Class I immune response

    		 Close Top of page
    End point title
    		 Overall survival by Class I immune response
    End point description
    OS based on Kaplan-Meier estimates and log-rank test by Class I immune response and Class I immune response ['99999'' indicates data was not available as upper limit of 95% confidence interval could not be determined.]
    End point type
    Secondary
    End point timeframe
    Survival from randomisation until death.
    End point values
    		 Class I immune Responder Class I immune Non-responder
    Number of subjects analysed
    51
    45
    Units: days
        median (confidence interval 95%)
    1241 (853 to 99999)
    973 (689 to 99999)
    Statistical analysis title
    		 Overall survival by T cell response
    Comparison groups
    Class I immune Responder v Class I immune Non-responder
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1806
    Method
    		 Logrank
    Confidence interval

    Secondary: Overall survival by Class I multi-peptide response

    		 Close Top of page
    End point title
    		 Overall survival by Class I multi-peptide response
    End point description
    OS based on Kaplan-Meier estimates and log-rank test by Class I multi-peptide response ['99999'' indicates that data was not available as upper limit of 95% confidence interval could not be determined.]
    End point type
    Secondary
    End point timeframe
    Survival from randomisation until death
    End point values
    		 Class I multi-peptide Responder Class I multi-peptide response Non-responder
    Number of subjects analysed
    16
    80
    Units: days
        median (confidence interval 95%)
    996 (732 to 99999)
    1033 (790 to 99999)
    Statistical analysis title
    		 Overall survival by T cell response
    Comparison groups
    Class I multi-peptide Responder v Class I multi-peptide response Non-responder
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8363
    Method
    		 Logrank
    Confidence interval

    Secondary: Best tumor response (central review)

    		 Close Top of page
    End point title
    		 Best tumor response (central review)
    End point description
    Best tumor response according to RECIST 1.1, based on the centrally reviewed tumor images.
    End point type
    Secondary
    End point timeframe
    CR=Complete response; PR=Partial response; SD=Stable disease; PD=Progressive disease; NE=Not evaluable
    End point values
    		 sunitinib plus IMA901 sunitinib
    Number of subjects analysed
    204
    135
    Units: Best overall response (unconfirmed)
        CR
    4
    8
        PR
    84
    56
        SD
    48
    31
        Non-CR/Non-PD
    18
    9
        PD
    31
    14
        NE
    19
    17
    No statistical analyses for this end point

    Secondary: Best tumor response (central review)

    		 Close Top of page
    End point title
    		 Best tumor response (central review)
    End point description
    Best tumor response according to RECIST 1.1, based on the centrally reviewed tumor images.
    End point type
    Secondary
    End point timeframe
    CR=Complete response; PR=Partial response; SD=Stable disease; PD=Progressive disease; NE=Not evaluable
    End point values
    		 sunitinib plus IMA901 sunitinib
    Number of subjects analysed
    204
    135
    Units: Best overall response (confirmed)
        CR
    4
    7
        PR
    69
    49
        SD
    58
    36
        Non-CR/Non-PD
    17
    10
        PD
    34
    15
        NE
    22
    18
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    The main safety analyis is based on treatment-emergent AEs (TEAEs) in the main phase defined as any AE that started or deteriorated after or at start of IMP treatment with cyclophosphamide at Visit D and before Visit 18/EOS.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    sunitinib plus IMA901
    Reporting group description
    		 Patients randomized to the vaccination arm (Arm 1) received a total of 10 vaccinations with IMA901 + GM-CSF (Visits 1 to 10) in addition to sunitinib during the vaccination period (length of approximately 4 months). Pre-treatment with Cyclophosphamide was given to all patients in Arm 1 three days before first vaccination.

    Reporting group title
    sunitinib
    Reporting group description
    		 Patients randomized to the control arm (Arm 2) received a sunitinib montherapy.

    Serious adverse events
    		 sunitinib plus IMA901 sunitinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    54 / 202 (26.73%)
    27 / 132 (20.45%)
         number of deaths (all causes)
    101
    54
         number of deaths resulting from adverse events
    5
    8
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric cancer
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic pain
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oncologic complication
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 202 (1.98%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    1 / 202 (0.50%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Aortic thrombosis
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Extremity necrosis
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 202 (0.50%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hyperthermia
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (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
    Pulmonary embolism
         subjects affected / exposed
    0 / 202 (0.00%)
    3 / 132 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Respiratory failure
         subjects affected / exposed
    2 / 202 (0.99%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 202 (0.50%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 202 (0.50%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tibia fracture
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 202 (0.50%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Headache
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 202 (1.49%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 202 (0.99%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 202 (0.50%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 202 (0.50%)
    4 / 132 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    4 / 202 (1.98%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 202 (0.50%)
    2 / 132 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 202 (0.50%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    2 / 202 (0.99%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flatulence
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal perforation
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periproctitis
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis acute
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatorenal failure
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyoderma gangrenosum
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 202 (0.00%)
    2 / 132 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal impairment
         subjects affected / exposed
    1 / 202 (0.50%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute prerenal failure
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    4 / 202 (1.98%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (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
    Pneumonia
         subjects affected / exposed
    3 / 202 (1.49%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyothorax
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sinusitis
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethritis
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 202 (0.50%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 202 (0.00%)
    1 / 132 (0.76%)
         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
    		 sunitinib plus IMA901 sunitinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    179 / 202 (88.61%)
    115 / 132 (87.12%)
    Investigations
    Weight decreased
         subjects affected / exposed
    30 / 202 (14.85%)
    16 / 132 (12.12%)
         occurrences all number
    47
    27
    Blood creatinine increased
         subjects affected / exposed
    18 / 202 (8.91%)
    16 / 132 (12.12%)
         occurrences all number
    20
    26
    Aspartate aminotransferase increased
         subjects affected / exposed
    15 / 202 (7.43%)
    10 / 132 (7.58%)
         occurrences all number
    28
    14
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    13 / 202 (6.44%)
    11 / 132 (8.33%)
         occurrences all number
    16
    15
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    17 / 202 (8.42%)
    3 / 132 (2.27%)
         occurrences all number
    25
    6
    Platelet count decreased
         subjects affected / exposed
    13 / 202 (6.44%)
    7 / 132 (5.30%)
         occurrences all number
    28
    18
    Vascular disorders
    Hypertension
         subjects affected / exposed
    51 / 202 (25.25%)
    31 / 132 (23.48%)
         occurrences all number
    80
    40
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    29 / 202 (14.36%)
    20 / 132 (15.15%)
         occurrences all number
    51
    31
    Headache
         subjects affected / exposed
    12 / 202 (5.94%)
    8 / 132 (6.06%)
         occurrences all number
    22
    10
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    42 / 202 (20.79%)
    30 / 132 (22.73%)
         occurrences all number
    70
    47
    Asthenia
         subjects affected / exposed
    35 / 202 (17.33%)
    16 / 132 (12.12%)
         occurrences all number
    80
    31
    Oedema peripheral
         subjects affected / exposed
    23 / 202 (11.39%)
    12 / 132 (9.09%)
         occurrences all number
    38
    17
    Mucosal inflammation
         subjects affected / exposed
    16 / 202 (7.92%)
    15 / 132 (11.36%)
         occurrences all number
    22
    24
    Injection site erythema
         subjects affected / exposed
    21 / 202 (10.40%)
    0 / 132 (0.00%)
         occurrences all number
    32
    0
    Pyrexia
         subjects affected / exposed
    11 / 202 (5.45%)
    8 / 132 (6.06%)
         occurrences all number
    22
    13
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    39 / 202 (19.31%)
    19 / 132 (14.39%)
         occurrences all number
    88
    41
    Anaemia
         subjects affected / exposed
    32 / 202 (15.84%)
    15 / 132 (11.36%)
         occurrences all number
    80
    37
    Thrombocytopenia
         subjects affected / exposed
    29 / 202 (14.36%)
    16 / 132 (12.12%)
         occurrences all number
    71
    42
    Leukopenia
         subjects affected / exposed
    24 / 202 (11.88%)
    20 / 132 (15.15%)
         occurrences all number
    66
    61
    Lymphopenia
         subjects affected / exposed
    11 / 202 (5.45%)
    7 / 132 (5.30%)
         occurrences all number
    26
    14
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    55 / 202 (27.23%)
    38 / 132 (28.79%)
         occurrences all number
    183
    112
    Nausea
         subjects affected / exposed
    40 / 202 (19.80%)
    25 / 132 (18.94%)
         occurrences all number
    63
    45
    Stomatitis
         subjects affected / exposed
    26 / 202 (12.87%)
    22 / 132 (16.67%)
         occurrences all number
    58
    34
    Vomiting
         subjects affected / exposed
    28 / 202 (13.86%)
    18 / 132 (13.64%)
         occurrences all number
    40
    33
    Dyspepsia
         subjects affected / exposed
    14 / 202 (6.93%)
    14 / 132 (10.61%)
         occurrences all number
    17
    17
    Abdominal pain upper
         subjects affected / exposed
    20 / 202 (9.90%)
    6 / 132 (4.55%)
         occurrences all number
    30
    14
    Abdominal pain
         subjects affected / exposed
    17 / 202 (8.42%)
    6 / 132 (4.55%)
         occurrences all number
    29
    8
    Constipation
         subjects affected / exposed
    9 / 202 (4.46%)
    9 / 132 (6.82%)
         occurrences all number
    10
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    19 / 202 (9.41%)
    11 / 132 (8.33%)
         occurrences all number
    21
    13
    Epistaxis
         subjects affected / exposed
    18 / 202 (8.91%)
    10 / 132 (7.58%)
         occurrences all number
    21
    13
    Dyspnoea
         subjects affected / exposed
    14 / 202 (6.93%)
    10 / 132 (7.58%)
         occurrences all number
    19
    12
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    55 / 202 (27.23%)
    38 / 132 (28.79%)
         occurrences all number
    147
    85
    Dry skin
         subjects affected / exposed
    15 / 202 (7.43%)
    7 / 132 (5.30%)
         occurrences all number
    18
    7
    Rash
         subjects affected / exposed
    15 / 202 (7.43%)
    5 / 132 (3.79%)
         occurrences all number
    18
    6
    Yellow skin
         subjects affected / exposed
    13 / 202 (6.44%)
    7 / 132 (5.30%)
         occurrences all number
    15
    10
    Hair colour changes
         subjects affected / exposed
    10 / 202 (4.95%)
    9 / 132 (6.82%)
         occurrences all number
    14
    9
    Erythema
         subjects affected / exposed
    11 / 202 (5.45%)
    7 / 132 (5.30%)
         occurrences all number
    14
    7
    Skin discolouration
         subjects affected / exposed
    12 / 202 (5.94%)
    6 / 132 (4.55%)
         occurrences all number
    27
    15
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    63 / 202 (31.19%)
    35 / 132 (26.52%)
         occurrences all number
    86
    46
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    24 / 202 (11.88%)
    9 / 132 (6.82%)
         occurrences all number
    31
    10
    Pain in extremity
         subjects affected / exposed
    17 / 202 (8.42%)
    11 / 132 (8.33%)
         occurrences all number
    28
    14
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    34 / 202 (16.83%)
    19 / 132 (14.39%)
         occurrences all number
    51
    27

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 May 2011
    - In the original study protocol sunitinib was considered a Non Investigational Medical Product (NIMP). With the amendment sunitinib was considered an Investigational Medicinal Product (IMP) and provided by the sponsor. The product provided is a clinical image material. The clinical image supplies are qualitatively and quantitatively identical to the commercial product with the exception that they lack markings on the capsule shell. - Specification for End of Trial (EoT) was included
    27 Sep 2013
    - With this amendment, the sponsor implemented the qualification criteria for continued sunitinib treatment after completion of the interventional period of the study. - Further, the specification of patient-follow up after primary completion date was given

    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.

    European Medicines Agency © 1995-Fri Apr 26 01:27:52 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA