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:
    T cell therapy for patients with advanced Ovarian Cancer

    Summary
    EudraCT number
    		 2015-000530-30
    Trial protocol
    		 DK  
    Global end of trial date
    03 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 May 2018
    First version publication date
    24 May 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GY1508
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02482090
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Inge Marie Svane
    Sponsor organisation address
    Herlev Ringvej 75, Herlev, Denmark, 2730
    Public contact
    Inge Marie Svane, Center for Cancer Immune Therapy, 0045 38682131, inge.marie.svane@regionh.dk
    Scientific contact
    Inge Marie Svane, Center for Cancer Immune Therapy, 0045 38682131, inge.marie.svane@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 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Apr 2017
    Was the trial ended prematurely?
    No
    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
    Not relevant
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2015
    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)
    4
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 All patients were enrolled in Herlev, Denmark between October 2015 to November 2016.

    Pre-assignment
    Screening details
    		 Eleven patients had tissue removed for TIL product generation. Five patients did not receive treatment due to: benign surgical biopsy for TIL production (n =1); unsuccessful TIL expansion (n = 1); clinical deterioration (n = 3)

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 TIL in ovarian cancer
    Arm description
    		 All patients receive the same treatment. Alle patients are hospitalized during treatment (approximately 3 weeks) and receive treatment only once. Stem Cells are harvested a minimum of 3 weeks before treatment for potential later use if the patients are having difficulties recovering from the lymphodepleting chemotherapy. The patients are admitted to hospital day -8 and receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine= on day -7 to day -1. The TILs are infused on day 0 and Interleukin-2 therapy is administered on day 0 to day 5. Interleukin-2 is administered in an i.v. continous decrescendo regimen starting approximately 6 hours after TIL infusion with a duration of approximately 5 days. Stem Cells can be administered after treatment if needed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tumor-infiltrating lymphocytes
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5x10e9 to 2x10e11 cells

    Number of subjects in period 1
    		TIL in ovarian cancer
    Started
    6
    Completed
    6

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 6 6
    Age categorical
    They were 50-65 years old (median 59 years) with CA-125 levels ranging from 10-4320 kU/L (median 214) and FIGO stage IIIc (n = 4) and IV (n = 2) disease, and had received two to six prior treatment regimens (median three)
    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)
    		 4 4
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    TIL in ovarian cancer
    Reporting group description
    		 All patients receive the same treatment. Alle patients are hospitalized during treatment (approximately 3 weeks) and receive treatment only once. Stem Cells are harvested a minimum of 3 weeks before treatment for potential later use if the patients are having difficulties recovering from the lymphodepleting chemotherapy. The patients are admitted to hospital day -8 and receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine= on day -7 to day -1. The TILs are infused on day 0 and Interleukin-2 therapy is administered on day 0 to day 5. Interleukin-2 is administered in an i.v. continous decrescendo regimen starting approximately 6 hours after TIL infusion with a duration of approximately 5 days. Stem Cells can be administered after treatment if needed.

    Primary: Tolerability and feasibility

    		 Close Top of page
    End point title
    		 Tolerability and feasibility [1]
    End point description
    There was no unexpected adverse events related to treatment.
    End point type
    Primary
    End point timeframe
    October 2015 - April 2017
    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: This was a pilot study treating patients with ovarian cancer with TIL therapy. No unexpected toxicity was observed in six patients and thus, treatment was deemed tolerable and feasible.
    End point values
    		 TIL in ovarian cancer
    Number of subjects analysed
    6
    Units: Events
    0
    No statistical analyses for this end point

    Secondary: Overall survival

    		 Close Top of page
    End point title
    		 Overall survival
    End point description
    Median overall survival at the time of data analysis
    End point type
    Secondary
    End point timeframe
    October 2015 - April 2017
    End point values
    		 TIL in ovarian cancer
    Number of subjects analysed
    6
    Units: months
    10
    No statistical analyses for this end point

    Secondary: Progression-free survival

    		 Close Top of page
    End point title
    		 Progression-free survival
    End point description
    Median progression-free survival
    End point type
    Secondary
    End point timeframe
    October 2015-April 2017
    End point values
    		 TIL in ovarian cancer
    Number of subjects analysed
    6
    Units: months
    6
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    October 2015 - April 2017
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    TIL in ovarian cancer
    Reporting group description
    		 All patients receive the same treatment. Alle patients are hospitalized during treatment (approximately 3 weeks) and receive treatment only once. Stem Cells are harvested a minimum of 3 weeks before treatment for potential later use if the patients are having difficulties recovering from the lymphodepleting chemotherapy. The patients are admitted to hospital day -8 and receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine= on day -7 to day -1. The TILs are infused on day 0 and Interleukin-2 therapy is administered on day 0 to day 5. Interleukin-2 is administered in an i.v. continous decrescendo regimen starting approximately 6 hours after TIL infusion with a duration of approximately 5 days. Stem Cells can be administered after treatment if needed.

    Serious adverse events
    		 TIL in ovarian cancer
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 6 (33.33%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Venous thrombosis
    Additional description: Deep venous thrombosis grade 2. Unrelated to treatment.
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fever
    Additional description: Fever grade 2 led to prolongation of hospitalization.
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
    Additional description: Dyspnoe grade 4. Related to treatment. Is a known adverse reaction to study treatment.
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 TIL in ovarian cancer
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    Investigations
    Hyponatraemia
    Additional description: Hyponatraemia grade 3. Related to treatment
         subjects affected / exposed
    6 / 6 (100.00%)
         occurrences all number
    6
    Hypophosphataemia
    Additional description: Hypophosphataemia grade 3. Related to treatment.
         subjects affected / exposed
    5 / 6 (83.33%)
         occurrences all number
    5
    Hypokalaemia
    Additional description: Hypokalaemia grade 3. Related to treatment.
         subjects affected / exposed
    5 / 6 (83.33%)
         occurrences all number
    5
    Nervous system disorders
    Confusional state
    Additional description: Confusional state grade 3. Related to treatment.
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Hallucination
    Additional description: Hallucination grade 3. Treatment related.
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    Performance status decreased
    Additional description: Performance status decreased to 3. Related to treatment
         subjects affected / exposed
    6 / 6 (100.00%)
         occurrences all number
    6
    Fever
    Additional description: Fever grade 3.
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Febrile neutropenia
    Additional description: Febrile neutropenia grade 3. Related to study treatment.
         subjects affected / exposed
    6 / 6 (100.00%)
         occurrences all number
    6
    Fatigue
    Additional description: Fatigue grade 3. Related to treatment
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
    Additional description: Grade 3. Related to treatment.
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1

    More information

    		 Close Top of page

    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.
    Pilot trial with only 6 trial subjects.
    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-Thu Apr 25 15:58:25 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA