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    Clinical Trial Results:
    A phase I- IIa open-label clinical trial, evaluating the therapeutic vaccine hVEGF26-104/RFASE in patients with advanced solid tumors

    Summary
    EudraCT number
    		 2013-002663-25
    Trial protocol
    		 NL  
    Global end of trial date
    01 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jan 2021
    First version publication date
    02 Jan 2021
    Other versions
    Summary report(s)
    		 Eindrapportage - wetenschappelijke publicatie 24-09-2020

    Trial information

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    Trial identification
    Sponsor protocol code
    VEGFVAX
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VU University Medical Center
    Sponsor organisation address
    De Boelelaan 1117, Amsterdam, Netherlands, 1081 HV
    Public contact
    Secretary Medical Oncology, VU University Medical Center, 0031 0204444321, r.goedegebuure@amsterdamumc.nl
    Scientific contact
    Secretary Medical Oncology, VU University Medical Center, 0031 0204444321, r.goedegebuure@amsterdamumc.nl
    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
    24 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part 1: The primary objectives of the study are: - To investigate the safety and tolerability profile of the therapeutic vaccine hVEGF26-104/RFASE. - To determine the effective dose of hVEGF26-104/RFASE required to neutralize VEGF in serum, defined as a VEGF level below 9,0 pg/mL. Part 2: - To investigate the safety and VEGF neutralizing ability of hVEGF26-104/RFASE combined with irinotecan chemotherapy in a metastatic colorectal cancer expansion cohort. - To investigate the safety and VEGF neutralizing ability of hVEGF26-104/RFASE combined with the XELOX regimen (capecitabine plus oxaliplatin) in a metastatic colorectal cancer expansion cohort.
    Protection of trial subjects
    Extensively described in studie protocol and approved by Dutch ethics committee (CCMO): 3+3 dose-escalating design, admission during clinical admission with extensive safety monitoring, saftey lab, bi weekly follow-up.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2013
    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
    Netherlands: 27
    Worldwide total number of subjects
    27
    EEA total number of subjects
    27
    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)
    10
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients with advanced solid malignancies with no standard treatment options available were eligible when fulfilling predefined in- and exclusion criteria

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dose-level 1
    Arm description
    		 VEGF26–104/RFASE 62.5 μg/20 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    hVEGF/RFASE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM injection on day 0, 14 and 28

    Arm title
    		 Dose-level 2
    Arm description
    		 hVEGF26–104/RFASE 125 μg/20 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    hVEGF/RFASE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM injection on day 0, 14 and 28

    Arm title
    		 Dose-level 3A
    Arm description
    		 hVEGF26–104/RFASE 250 μg/20 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    hVEGF/RFASE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM injection on day 0, 14 and 28

    Arm title
    		 Dose-level 3B
    Arm description
    		 hVEGF26–104/RFASE 250 μg/40 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    hVEGF/RFASE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM injection on day 0, 14 and 28

    Arm title
    		 Dose-level 4
    Arm description
    		 hVEGF26–104/RFASE 500 μg/40 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    hVEGF/RFASE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM injection on day 0, 14 and 28

    Arm title
    		 Dose-level 5
    Arm description
    		 hVEGF26–104/RFASE 1.000 μg/40 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    hVEGF/RFASE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    IM injection on day 0, 14 and 28

    Number of subjects in period 1
    		Dose-level 1 Dose-level 2 Dose-level 3A Dose-level 3B Dose-level 4 Dose-level 5
    Started
    4
    3
    4
    4
    8
    4
    Completed
    4
    3
    4
    4
    7
    4
    Not completed
    0
    0
    0
    0
    1
    0
         did not commence treatment
    -
    -
    -
    -
    1
    -

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Dose-level 1
    Reporting group description
    		 VEGF26–104/RFASE 62.5 μg/20 mg

    Reporting group title
    Dose-level 2
    Reporting group description
    		 hVEGF26–104/RFASE 125 μg/20 mg

    Reporting group title
    Dose-level 3A
    Reporting group description
    		 hVEGF26–104/RFASE 250 μg/20 mg

    Reporting group title
    Dose-level 3B
    Reporting group description
    		 hVEGF26–104/RFASE 250 μg/40 mg

    Reporting group title
    Dose-level 4
    Reporting group description
    		 hVEGF26–104/RFASE 500 μg/40 mg

    Reporting group title
    Dose-level 5
    Reporting group description
    		 hVEGF26–104/RFASE 1.000 μg/40 mg

    Primary: Safety and tolerability

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    End point title
    		 Safety and tolerability [1]
    End point description
    End point type
    Primary
    End point timeframe
    overall clinical trial
    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: Descriptive data
    End point values
    		 Dose-level 1 Dose-level 2 Dose-level 3A Dose-level 3B Dose-level 4 Dose-level 5
    Number of subjects analysed
    4
    3
    3
    4
    7 [2]
    4
    Units: Grade 3 or higher related adverse events
    0
    0
    0
    0
    0
    0
    Notes
    [2] - 1 did not commence treatment
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Whole clinical trial
    Adverse event reporting additional description
    Please see PMID: 33105058 DOI: 10.1002/onco.13576
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Whole clinical trial
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Please see PMID: 33105058 DOI: 10.1002/onco.13576
    Serious adverse events
    		 Whole clinical trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 26 (65.38%)
         number of deaths (all causes)
    8
         number of deaths resulting from adverse events
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pain
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    tromboembolic event
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Confusional state
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Somnolence
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    anemia
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    2 / 26 (7.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Fever
         subjects affected / exposed
    3 / 26 (11.54%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Whole clinical trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)

    More information

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

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

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33105058
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