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    Clinical Trial Results:
    An exploratory study: Dendritic cells for immunotherapy of metastatic endometrial cancer patients

    Summary
    EudraCT number
    		 2018-004467-31
    Trial protocol
    		 NL  
    Global end of trial date
    01 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2022
    First version publication date
    25 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DECENDO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04212377
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboud University Medical Center
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands, 6525 GA
    Public contact
    Dept of Tumor Immunology, Radboud University Medical Center, 0031 24 361 76 00, dcvaccinatie.til@radboudumc.nl
    Scientific contact
    Dept of Tumor Immunology, Radboud University Medical Center, 0031 24 361 76 00, dcvaccinatie.til@radboudumc.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
    01 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this exploratory study is to show immunologic efficacy of tumor-peptide-loaded natural DC in mEC patients. The immune-monitoring will include: a) functional response and dextramer analysis of DTH infiltrating lymphocytes against tumor peptides, b) type I IFN gene expression in PBMC shortly after vaccination, and c) proliferative, effector cytokine- and humoral responses to keyhole limpet hemocyanin (KLH), an immunogenic protein providing T cell help.
    Protection of trial subjects
    Dendritic cell vaccination is a safe and generally well tolerated treatment. Common side effects are flu-like symptoms and local reaction at the injection side. Patients were allowed to use paracetamol to alleviate these symptoms if needed. Adverse events were monitored throughout the study. All serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) were reported via ToetsingOnline to the CCMO. All adverse events will be followed until they have abated, or until a stable situation has been reached. Depending on the event, follow up may require additional tests or medical procedures as indicated, and/or referral to the general physician or a medical specialist. A progress and safety report was submited to the CCMO on a yearly basis.
    Background therapy
    		 All patients in the trial received chemotherapy with carboplatin (AUC 4) and paclitaxel (90 mg/m2) in a weekly schedule for six cycles. If patients demonstrated at least stable disease, they received three more cycles of carboplatin (AUC 5) and paclitaxel (175 mg/m2) in a three-weekly schedule along with DC vaccination.
    Evidence for comparator
    		 N.a. in this single-arm study.
    Actual start date of recruitment
    08 Apr 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    2
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place between April 8th 2019 and July 16th 2020.

    Pre-assignment
    Screening details
    		 One screening failure occurred, due to rapid disease progression, becoming evident between signing of informed consent and the first study procedure.

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

    Arms
    Arm title
    		 nDC vaccination
    Arm description
    		 Patients in the study received a total of six peptide- and KLH-pulsed nDC-vaccinations in addition to the platinum-based chemotherapy regimen as described earlier.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Autologous tumor antigen peptide-, and KLH-loaded blood-derived natural dendritic cell
    Investigational medicinal product code
    ENDO-DC
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intralymphatic use
    Dosage and administration details
    A total of six vaccinations (3 per round) of nDC, each consisting of 5 million cells/dose

    Number of subjects in period 1
    		nDC vaccination
    Started
    7
    Completed
    7

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 7 7
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Age in years at the time of inclusion
    Units: years
        median (full range (min-max))
    		 65 (58 to 71) -
    Gender categorical
    All patients included were female.
    Units: Subjects
        Female
    		 7 7
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    nDC vaccination
    Reporting group description
    		 Patients in the study received a total of six peptide- and KLH-pulsed nDC-vaccinations in addition to the platinum-based chemotherapy regimen as described earlier.

    Primary: KLH-response after nDC-vaccination

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    End point title
    		 KLH-response after nDC-vaccination [1]
    End point description
    In vitro proliferation of patient-derived PBMCs after exposure to KLH, as measured by a standard 3H-thymidine incorporation assay. Cutoff for positive response was defined as a two-fold increase over KLH-stimulated proliferation in baseline PBMCs.
    End point type
    Primary
    End point timeframe
    After first round of nDC vaccinations
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No comparative analysis was performed for the primary endpoints in this single-arm study.
    End point values
    		 nDC vaccination
    Number of subjects analysed
    5 [2]
    Units: Subjects with a KLH-response
        Responders
    2
        Non-responders
    3
    Notes
    [2] - Only patients who received at least one nDC vaccination were included in this analysis.
    No statistical analyses for this end point

    Primary: Tumor peptide-specific immune response

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    End point title
    		 Tumor peptide-specific immune response [3]
    End point description
    Tumor peptide specificity was assessed in T-cells obtained from a vaccine-challenged site (DTH) by measuring different effector cytokines in response to tumor-specific peptides.
    End point type
    Primary
    End point timeframe
    After the first and second round of nDC-vaccinations
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No comparative analysis was performed for the primary endpoints in this single-arm study.
    End point values
    		 nDC vaccination
    Number of subjects analysed
    3 [4]
    Units: Number of patients with a response
        Responder
    1
        Non-responder
    2
    Notes
    [4] - A sufficient amount of T-cells for this analysis were available for three patients.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were
    Adverse event reporting additional description
    Adverse events were collected during each clinic visit by the treating physician and reported in the electronic patient file.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    nDC vaccination
    Reporting group description
    		 Patients in the study received a total of six peptide- and KLH-pulsed nDC-vaccinations in addition to the platinum-based chemotherapy regimen as described earlier.

    Serious adverse events
    		 nDC vaccination
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 7 (28.57%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Intrathoracic bleeding
    Additional description: Intrathoracic bleeding as complication of an image-guided biopsy.
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diverticulitis
    Additional description: Mild diverticulitis warranting admission to a hospital only because of quick diagnostic workup prior to planned start of chemotherapy.
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 nDC vaccination
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 7 (85.71%)
    General disorders and administration site conditions
    Flu-like symptoms
         subjects affected / exposed
    4 / 7 (57.14%)
         occurrences all number
    4
    Any chemotherapy-related adverse events
         subjects affected / exposed
    6 / 7 (85.71%)
         occurrences all number
    6

    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
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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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