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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41449   clinical trials with a EudraCT protocol, of which   6808   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    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:
    A multi-center, open-label trial investigating the efficacy and safety of continued treatment with tisotumab vedotin in patients with solid tumors known to express tissue factor

    Summary
    EudraCT number
    2016-004743-37
    Trial protocol
    BE   GB   SE   HU   DK  
    Global end of trial date
    10 Jan 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Apr 2021
    First version publication date
    14 Apr 2021
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    GCT1015-03
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03245736
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Genmab A/S
    Sponsor organisation address
    Kalvebod Brygge 43, Copenhagen V, Denmark, DK-1560
    Public contact
    Clinical Trial Information, Genmab A/S, +45 70202728, clinicaltrials@genmab.com
    Scientific contact
    Clinical Trial Information, Genmab A/S, +45 70202728, clinicaltrials@genmab.com
    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
    10 Jan 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To collect long-term safety data from participants with solid tumors who have been treated with tisotumab vedotin and completed any base trial (i.e., GEN701 - 2013-001074-15 or GEN702 - 2015-001120-29)
    Protection of trial subjects
    This trial was conducted in accordance with the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) E6 (R2); the United States of America (USA) Food and Drug Administration (FDA) Code of Federal Regulations (CFR) (21 CFR § 50, 56, 312), the Declaration of Helsinki (Fortaleza 2013), and all applicable regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 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
    United States: 1
    Country: Number of subjects enrolled
    United Kingdom: 4
    Worldwide total number of subjects
    5
    EEA total number of subjects
    4
    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)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    All participants entered the trial following completion of other tisotumab vedotin trials such as GEN701 and GEN702. A total of 5 participants took part in the trial at 3 sites in the United Kingdom and 1 site in the United States from 23 August 2017 to 10 January 2019.

    Pre-assignment
    Screening details
    Six participants were screened, 5 of which were enrolled.

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

    Arms
    Arm title
    Tisotumab Vedotin
    Arm description
    Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.
    Arm type
    Experimental

    Investigational medicinal product name
    Tisotumab vedotin
    Investigational medicinal product code
    Other name
    HuMax®-TF-ADC
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 2.0 mg/kg or if dose reduced, the same dose as in base trial by intravenous infusion, over a minimum of 30 minutes.

    Number of subjects in period 1
    Tisotumab Vedotin
    Started
    5
    Completed
    0
    Not completed
    5
         Adverse event, non-fatal
    1
         Progressive Disease
    4

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Tisotumab Vedotin
    Reporting group description
    Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.

    Reporting group values
    Tisotumab Vedotin Total
    Number of subjects
    5 5
    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)
    5 5
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    5 5
        Male
    0 0
    Race
    Units: Subjects
        White
    5 5

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Tisotumab Vedotin
    Reporting group description
    Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.

    Primary: Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)

    Close Top of page
    End point title
    Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE) [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment emergent adverse event (TEAE) is an AE occurring on or after the first dose of study medication or worsening during treatment period.
    End point type
    Primary
    End point timeframe
    Day 1 to Week 24 plus 30 days
    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: Given the low expected number of participants, no formal statistical analyses were planned.
    End point values
    Tisotumab Vedotin
    Number of subjects analysed
    5
    Units: Participants
    5
    No statistical analyses for this end point

    Secondary: Objective Response Rate

    Close Top of page
    End point title
    Objective Response Rate
    End point description
    Objective Response was investigator-assessed based on the Response Evaluation Criteria In Solid Tumors version 1.1 [RECIST 1.1] criteria. The best overall response was reported for each participant.
    End point type
    Secondary
    End point timeframe
    Day 1 to Week 24 plus 30 days
    End point values
    Tisotumab Vedotin
    Number of subjects analysed
    5
    Units: Participants
        Complete Response
    0
        Partial Response
    2
        Stable Disease
    2
        Progressive Disease
    1
    No statistical analyses for this end point

    Secondary: Number of Participants with Increased Cancer Antigen (CA 125) Levels

    Close Top of page
    End point title
    Number of Participants with Increased Cancer Antigen (CA 125) Levels
    End point description
    The number of participants with ovarian cancer whose levels of CA125 Antigen had increased since the end of the base trial are presented.
    End point type
    Secondary
    End point timeframe
    Day 1 to Week 24 plus 30 days
    End point values
    Tisotumab Vedotin
    Number of subjects analysed
    2
    Units: Participants
    1
    No statistical analyses for this end point

    Secondary: Number of Participants with Increased Prostate Specific Antigen (PSA)

    Close Top of page
    End point title
    Number of Participants with Increased Prostate Specific Antigen (PSA)
    End point description
    The number of participants with prostate cancer whose levels of PSA had increased since the end of the base trial are presented.
    End point type
    Secondary
    End point timeframe
    Day 1 to Week 24 plus 30 days
    End point values
    Tisotumab Vedotin
    Number of subjects analysed
    0 [2]
    Units: Participants
    Notes
    [2] - No participants with prostate cancer participated in this trial.
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to Week 24 plus 30 days
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    -

    Serious adverse events
    Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    1 / 5 (20.00%)
         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
    Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    Vascular disorders
    Venous thrombosis limb
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 5 (40.00%)
         occurrences all number
    2
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    4 / 5 (80.00%)
         occurrences all number
    5
    Balance disorder
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Eye disorders
    Retinal exudates
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Ocular toxicity
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Corneal thinning
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Punctate keratitis
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 5 (40.00%)
         occurrences all number
    2
    Infections and infestations
    Localised infection
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Dec 2016
    The purpose of this protocol amendment was to modify the dose modification and the mitigation plan for ocular events accordingly.
    27 Jul 2017
    The purpose for this amendment was to align the treatment schedule with one of the base trials, and implement improved mitigation plan for ocular AE and reporting requirement.
    30 Nov 2017
    The protocol was amended to align with one of the base trials updated inclusion and exclusion criteria, permitted concomitant medications and AEs including medication errors, overdose and pregnancies reporting requirement.

    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
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA