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    Clinical Trial Results:
    Estudio fase II con inmunoterapia mediante células dendríticas e Hiltonol en pacientes con tumores sólidos.

    Summary
    EudraCT number
    		 2010-023139-40
    Trial protocol
    		 ES  
    Global end of trial date
    19 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CD-2010-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01734564
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clinica Universidad de Navarra
    Sponsor organisation address
    AVENIDA PÍO XII, Nº 36, PAMPLONA/IRUÑA, Spain, 31008
    Public contact
    UCEC, Clinica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
    Scientific contact
    UCEC, Clinica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
    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 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    19 May 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Tumor response rate assessed by RECIST criteria
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Mar 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
    Spain: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 It is intended to include patients with advanced solid tumors without conventional treatment. The study has two cohorts. In one of them, treatment with only dendritic cells and Hiltonol will be administered and in the second treatment with radiotherapy will be added.

    Pre-assignment
    Screening details
    		 17 subjects are included of which 15 complete the study and 2 are screening failures. In the first cohort, 10 patients were included, of which 1 was a screening failure. In the second cohort, 7 patients were included, of which 1 was a screening failure.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1
    Arm description
    		 Hiltonol and autologous dendritic cells
    Arm type
    		 Experimental

    Investigational medicinal product name
    Autologous dendritic cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    The expected dose of dendritic cells is 5-10x10E6, resuspended in 0.5-1 ml of physiological saline. If there are not enough cells to complete the treatment, those that are available will be administered, reducing the dose or the number of injections.

    Investigational medicinal product name
    Hiltonol
    Investigational medicinal product code
    Other name
    poly-ICLC
    Pharmaceutical forms
    Injection
    Routes of administration
    Intratumoral use
    Dosage and administration details
    Patients will receive 2 doses of Hiltonol 0.25 mg by intratumoral injection.

    Arm title
    		 Cohort 2
    Arm description
    		 Hiltonol, dendritic cells and radiation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Autologous dendritic cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    The expected dose of dendritic cells is 5-10x10E6, resuspended in 0.5-1 ml of physiological saline. If there are not enough cells to complete the treatment, those that are available will be administered, reducing the dose or the number of injections.

    Investigational medicinal product name
    Hiltonol
    Investigational medicinal product code
    Other name
    poly-ICLC
    Pharmaceutical forms
    Injection
    Routes of administration
    Intratumoral use
    Dosage and administration details
    Patients will receive 2 doses of Hiltonol 0.25 mg by intratumoral injection.

    Number of subjects in period 1
    		Cohort 1 Cohort 2
    Started
    9
    6
    Completed
    9
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 15 15
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 10 10
        From 65-84 years
    		 5 5
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Hiltonol and autologous dendritic cells

    Reporting group title
    Cohort 2
    Reporting group description
    		 Hiltonol, dendritic cells and radiation

    Primary: Response rate

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    End point title
    		 Response rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    8-10 weeks
    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: It is primarily a descriptive statistic.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    9
    6
    Units: Number of patients
        SD
    4
    5
        PD
    5
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During treatment.
    Adverse event reporting additional description
    The incidence of all treatment-related adverse events is presented.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 -

    Reporting group title
    Cohort 2
    Reporting group description
    		 -

    Serious adverse events
    		 Cohort 1 Cohort 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 9 (22.22%)
    2 / 6 (33.33%)
         number of deaths (all causes)
    8
    5
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Hospitalisation
         subjects affected / exposed
    2 / 9 (22.22%)
    2 / 6 (33.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Cohort 1 Cohort 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    5 / 6 (83.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 9 (33.33%)
    3 / 6 (50.00%)
         occurrences all number
    3
    3
    Local reaction
         subjects affected / exposed
    7 / 9 (77.78%)
    2 / 6 (33.33%)
         occurrences all number
    7
    2
    Decreased appetite
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Infusion related reaction
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 6 (16.67%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jul 2013
    New version of IMPD file 09-033.
    05 Feb 2015
    New cohort associating radiotherapy with treatment with dendritic cells and hiltonol.
    04 Feb 2016
    The possibility of performing tumor biopsies, for research purposes, during the trial treatment is added. The radiotherapy administration scheme is optimized. Errata are corrected in the protocol.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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