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    Clinical Trial Results:
    Phase II trial of Pembrolizumab in combination with Doxorubicin in Advanced, Recurrent or Metastatic Endometrial Cancer (TOPIC)

    Summary
    EudraCT number
    		 2017-002824-26
    Trial protocol
    		 ES  
    Global end of trial date
    31 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2022
    First version publication date
    26 Jun 2022
    Other versions
    Summary report(s)
    		 Justification_no_results_available
    Abstract

    Trial information

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    Trial identification
    Sponsor protocol code
    VHIO17001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03276013
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 TOPIC: VHIO17001
    Sponsors
    Sponsor organisation name
    Vall d'Hebron Institute of Oncology (VHIO)
    Sponsor organisation address
    Carrer de Natzaret, 117, Barcelona, Spain, 08035
    Public contact
    Sponsor, Clinical Research Support Unit, Vall d' Hebron Institute of Oncology (VHIO), 34 9325434508614, mcarboneras@vhio.net
    Scientific contact
    Sponsor, Vall d' Hebron Institute of Oncology (VHIO), 686187838 9325434508614, mcarboneras@vhio.net
    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
    Interim
    Date of interim/final analysis
    10 Jun 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the efficacy of anti-PD1 blockade with pembrolizumab in combination with immunogenic chemotherapy with doxorubicin in patients with recurrent endometrial cancer in terms of patients who survived progression free (PFS) at least 6 months. Therefore the primary efficacy objective in this triail is PFS rate at 6 months according to RECIST 1.1 criteria.
    Protection of trial subjects
    This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2018
    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: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    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)
    22
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects with recurrent/metastatic endometrial cancer and progressive disease after platinum-containing cytotoxic chemotherapy. Subjects with advanced epithelial endometrial tumor histologies, including endometriod, serous, clear cell, and squamous carcinoma were enrolled.

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

    Arms
    Arm title
    		 Complete Set
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pembrolizumab in combination with Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Doxorubicin 60 mg/kg IV over 30 minutes on day 1 every 3 weeks up to 9 cycles in combination with Pembrolizumab (MK-3475) 200 mg IV Q3W

    Number of subjects in period 1
    		Complete Set
    Started
    48
    Completed
    48

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Complete Set
    Reporting group description
    		 -

    Subject analysis set title
    Complete Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients receiving treatment

    Primary: PFS rate at 6 months

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    End point title
    		 PFS rate at 6 months [1]
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    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: We are currently finalizing the final statistical analysis on all pre-specified outcome measures. Consequently, no results are available for this trial.
    End point values
    		 Complete Set
    Number of subjects analysed
    Units: %
    48
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From the time of treatment allocation through 30 days following cessation of treatment, all adverse events were reported by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: We are currently finalizing the final statistical analysis on all pre-specified outcome measures. Consequently, no results are available for this trial

    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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