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    Clinical Trial Results:
    T-cell therapy in combination with checkpoint inhibitors for patients with advanced ovarian-, fallopian tube- and primary peritoneal cancer.

    Summary
    EudraCT number
    		 2017-002179-24
    Trial protocol
    		 DK  
    Global end of trial date
    02 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jul 2020
    First version publication date
    03 Jul 2020
    Other versions
    Summary report(s)
    		 Summary of results

    Trial information

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    Trial identification
    Sponsor protocol code
    GY1721
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03287674
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    National Center for Cancer Immune Therapy (CCIT-DK)
    Sponsor organisation address
    Borgmester Ib Juuls Vej 25C, Herlev, Denmark, 2730
    Public contact
    National Center for Cancer Immune Therapy, National Center for Cancer Immune Therapy, 0045 38683868, anders.kverneland@regionh.dk
    Scientific contact
    National Center for Cancer Immune Therapy, National Center for Cancer Immune Therapy, 0045 4538683868, anders.kverneland@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jun 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jun 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate toxicity (according to CTCAE version 4.0) and feasibility.
    Protection of trial subjects
    All side effects were treated in accordance with best clinical practice.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    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)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients were recruited from Danish oncology centers between 2017-2018.

    Pre-assignment
    Screening details
    		 Patients eligible for therapy were screening at Herlev Hospital according to in- and exclusion criteria described in the protocol.

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

    Arms
    Arm title
    		 TILs and checkpoint inhibition
    Arm description
    		 Ipilimumab, Cyclophosphamide, Fludarabine, TILs, Nivolumab, IL-2
    Arm type
    		 Experimental

    Investigational medicinal product name
    cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    60 mg/kg daily for 2 days. Day -7 and -6 before TIL infusion

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg once, 2 weeks before tumor removal

    Investigational medicinal product name
    Fludarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    25 mg/m2 daily (max 50 mg) for 5 days. At day -5 to -1 before TIL infusion

    Investigational medicinal product name
    Tumor infiltrating lymphocytes
    Investigational medicinal product code
    Other name
    TILs, REP-TILs
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Typically 25-100 billion autologous T-cells expanded ex vivo from patients's own metastasis

    Investigational medicinal product name
    Interleukin-2
    Investigational medicinal product code
    Other name
    IL-2, aldesleukin
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 MIE daily for 14 days. Starting at day +1 after TIL infusion

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg every 14 days until 4 doses. Starting on day -2 before TILs.

    Number of subjects in period 1
    		TILs and checkpoint inhibition
    Started
    6
    7 patients recruited
    6
    6 patients treated
    6
    6 patients discontinued after therapy
    6
    Completed
    6

    Baseline characteristics

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

    Reporting group values
    		 Treatment time Total
    Number of subjects
    		 6 6
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    TILs and checkpoint inhibition
    Reporting group description
    		 Ipilimumab, Cyclophosphamide, Fludarabine, TILs, Nivolumab, IL-2

    Primary: Feasibility

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    End point title
    		 Feasibility [1]
    End point description
    Succcesful ex vivo expansion and re-infused into the patient
    End point type
    Primary
    End point timeframe
    Oct-2017 to july 2018
    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: The clinical trial is very small with only 6 participants. No consideration was given to statistical power. Statistical analyses involve non-parametric comparisons.
    End point values
    		 TILs and checkpoint inhibition
    Number of subjects analysed
    6
    Units: Succesful TIL therapy
        Succesful ex vivo expansion
    6
        Succesful re-infusion
    6
    No statistical analyses for this end point

    Secondary: Overall response rate

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    End point title
    		 Overall response rate
    End point description
    Best overall response according to RECIST 1.1.
    End point type
    Secondary
    End point timeframe
    3-9 months after TIL infusion
    End point values
    		 TILs and checkpoint inhibition
    Number of subjects analysed
    6
    Units: No. subjects
        Complete response
    0
        Partial response
    1
        Stabile disease
    5
        Progressive disease
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from recruitment to discontinuation from protocol
    Adverse event reporting additional description
    CTCAE 4.0. Non-serious event are only reported if grade>2
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    TIL treated group
    Reporting group description
    		 -

    Serious adverse events
    		 TIL treated group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 6 (66.67%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Hypogammaglobulinaemia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Red blood cell count decreased
    Additional description: anemia following discharge
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colitis
    Additional description: Following ipilimumab
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory symptom
    Additional description: Serious respiratory deficiency following TIL infusion
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cystitis
    Additional description: In relation to JJ cathether
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 TIL treated group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    General disorders and administration site conditions
    Performance status decreased
         subjects affected / exposed
    3 / 6 (50.00%)
         occurrences all number
    6
    Fatigue
         subjects affected / exposed
    3 / 6 (50.00%)
         occurrences all number
    6
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    6 / 6 (100.00%)
         occurrences all number
    6
    red blood cell reduced
         subjects affected / exposed
    6 / 6 (100.00%)
         occurrences all number
    7
    Platelet count decreased
         subjects affected / exposed
    6 / 6 (100.00%)
         occurrences all number
    6
    Immune system disorders
    Infection
    Additional description: Infetion during immune suspression
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Renal and urinary disorders
    Hyponatraemia
         subjects affected / exposed
    3 / 6 (50.00%)
         occurrences all number
    3
    Endocrine disorders
    Thyroiditis
    Additional description: immune mediated
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Infections and infestations
    Fever
    Additional description: Fever>40
         subjects affected / exposed
    3 / 6 (50.00%)
         occurrences all number
    3

    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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