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    Clinical Trial Results:
    Efficacy of immunotherapy in patients with MMR-deficient localized colon cancer scheduled for curative surgery - A prospective, phase II study

    Summary
    EudraCT number
    		 2021-006046-12
    Trial protocol
    		 DK  
    Global end of trial date
    06 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Aug 2025
    First version publication date
    13 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    05011121
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05662527
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Camilla Qvortrup, Rigshospitalet, +45 35455909, camilla.qvortrup@regionh.dk
    Scientific contact
    Camilla Qvortrup, Rigshospitalet, +45 35455909, camilla.qvortrup@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
    18 Jun 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to evaluate the efficacy of neoadjuvant treatment with pembrolizumab before colonic resection in patients with early-stage (I-III) dMMR colon cancer.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2022
    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: 85
    Worldwide total number of subjects
    85
    EEA total number of subjects
    85
    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)
    14
    From 65 to 84 years
    68
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Between February 17th, 2023 and March 1st, 2024 a total of 117 patients were assessed for eligibility in the study

    Period 1
    Period 1 title
    Actual start of recruitment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Pembrolizumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate and solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    4mg/kg (maximum 400mg) intravenous infusion administered over 30 min.

    Number of subjects in period 1
    		Pembrolizumab
    Started
    85
    Completed
    85

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Actual start of recruitment
    Reporting group description
    		 -

    Reporting group values
    		 Actual start of recruitment Total
    Number of subjects
    		 85 85
    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)
    		 14 14
        From 65-84 years
    		 68 68
        85 years and over
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 61 61
        Male
    		 24 24

    End points

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    End points reporting groups
    Reporting group title
    Pembrolizumab
    Reporting group description
    		 -

    Primary: Pathological complete response

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    End point title
    		 Pathological complete response [1]
    End point description
    End point type
    Primary
    End point timeframe
    At time of surgery
    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: It is a single arm thus non-comperative study therefore not no statistical analyses have been added
    End point values
    		 Pembrolizumab
    Number of subjects analysed
    84 [2]
    Units: Rate
    37
    Notes
    [2] - One patient did not undergo surgery
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Until 4 weeks after surgey
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    Pembrolizumab
    Reporting group description
    		 -

    Serious adverse events
    		 Pembrolizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 85 (5.88%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    hepatitis
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Adrenal insufficiency
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Myositis
         subjects affected / exposed
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pembrolizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    70 / 85 (82.35%)
    Investigations
    alan
         subjects affected / exposed
    4 / 85 (4.71%)
         occurrences all number
    4
    Anaemia
         subjects affected / exposed
    19 / 85 (22.35%)
         occurrences all number
    19
    Weight decreased
         subjects affected / exposed
    7 / 85 (8.24%)
         occurrences all number
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 85 (5.88%)
         occurrences all number
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    32 / 85 (37.65%)
         occurrences all number
    32
    Immune system disorders
    Hyperthyroidism
         subjects affected / exposed
    7 / 85 (8.24%)
         occurrences all number
    7
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    15 / 85 (17.65%)
         occurrences all number
    15
    Constipation
         subjects affected / exposed
    4 / 85 (4.71%)
         occurrences all number
    4
    Appetite disorder
         subjects affected / exposed
    13 / 85 (15.29%)
         occurrences all number
    13
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    10 / 85 (11.76%)
         occurrences all number
    10
    Pneumonia
         subjects affected / exposed
    4 / 85 (4.71%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    6 / 85 (7.06%)
         occurrences all number
    6
    Rash
         subjects affected / exposed
    7 / 85 (8.24%)
         occurrences all number
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 85 (8.24%)
         occurrences all number
    7
    Myalgia
         subjects affected / exposed
    4 / 85 (4.71%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Sep 2023
    addition of secondary endpoints Change in the expected end date of study

    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.
    Non randomized

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/39692004
    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.

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