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    Clinical Trial Results:
    Immunomodulation of pembrolizumab plus docetaxel for the treatment of r/m SCCHN after platinum failure

    Summary
    EudraCT number
    		 2015-002325-18
    Trial protocol
    		 AT  
    Global end of trial date
    27 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2024
    First version publication date
    20 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PemDoc
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02718820
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedUniWien
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Marika Rosner, MedUniWien, +43 14040044450, marika.rosner@meduniwien.ac.at
    Scientific contact
    Thorsten Füreder, MedUniWien, +43 14040044450, thorsten.fuereder@meduniwien.ac.at
    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
    27 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the Overall Response Rate (CR/PR) rate and Progression Free Survival (PFS) in patients treated with pembrolizumab plus docetaxel for recurrent or metastatic (R/M) HNSCC after platinum-based first-line therapy • To evaluate the safety of pembrolizumab in combination with docetaxel in subjects diagnosed with R/M HNSCC
    Protection of trial subjects
    CT Thorax/Abdomen every 12 weeks
    Background therapy
    		 antiemetics and dexamethason before and 3 days after administration of docetaxel
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Dec 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
    Austria: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    13
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 22 patient were enrolled in this single-site at the University Hospital Vienna

    Pre-assignment
    Screening details
    		 22 patient were screened according to the inclusion and exclusion criteria

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

    Arms
    Arm title
    		 Treatment arm
    Arm description
    		 There is only one arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    75mg/m2 every 3 weeks

    Investigational medicinal product name
    Pembolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200mg every 3 weeks

    Number of subjects in period 1
    		Treatment arm
    Started
    22
    Completed
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 22 22
    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)
    		 13 13
        From 65-84 years
    		 9 9
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 18 18
    Subject analysis sets

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Docetaxel 75mg/m2 plus pembrolizumab 200mg will be administered every 3 weeks intravenously for 6 cycles. Thereafter pembrolizumab 200mg every 3 weeks will be given as maintenance therapy until progression. Docetaxel: Docetaxel 75mg/m2; q21 Pembrolizumab: Pembrolizumab 200mg, q21

    Subject analysis sets values
    		 Overall trial
    Number of subjects
    22
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    13
        From 65-84 years
    9
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    4
        Male
    18

    End points

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    End points reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 There is only one arm

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Docetaxel 75mg/m2 plus pembrolizumab 200mg will be administered every 3 weeks intravenously for 6 cycles. Thereafter pembrolizumab 200mg every 3 weeks will be given as maintenance therapy until progression. Docetaxel: Docetaxel 75mg/m2; q21 Pembrolizumab: Pembrolizumab 200mg, q21

    Primary: objective tumor response

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    End point title
    		 objective tumor response
    End point description
    End point type
    Primary
    End point timeframe
    Baseline until end of treatment
    End point values
    		 Treatment arm Overall trial
    Number of subjects analysed
    22
    22
    Units: mg/m2;q21
        median (confidence interval 95%)
    22.7 (10.1 to 43.3)
    22.7 (10.1 to 43.3)
    Statistical analysis title
    		 Objective responses rate
    Comparison groups
    Treatment arm v Overall trial
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 descriptive statistics
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Time the consent is signed through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Treatment-related AEs
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment-related AEs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 22 (31.82%)
         number of deaths (all causes)
    14
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Neutropenic infection
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    emesis
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment-related AEs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 22 (100.00%)
    Nervous system disorders
    Vertigo
         subjects affected / exposed
    8 / 22 (36.36%)
         occurrences all number
    8
    Polyneuropathy
         subjects affected / exposed
    9 / 22 (40.91%)
         occurrences all number
    9
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    14 / 22 (63.64%)
         occurrences all number
    14
    Blood and lymphatic system disorders
    Petechiae
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Anaemia
         subjects affected / exposed
    4 / 22 (18.18%)
         occurrences all number
    4
    Neutropenia
         subjects affected / exposed
    4 / 22 (18.18%)
         occurrences all number
    4
    Immune system disorders
    fever
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 22 (18.18%)
         occurrences all number
    4
    emesis
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    9 / 22 (40.91%)
         occurrences all number
    9
    Mucositis
         subjects affected / exposed
    9 / 22 (40.91%)
         occurrences all number
    9
    Erythema
         subjects affected / exposed
    13 / 22 (59.09%)
         occurrences all number
    13
    Alopecia
         subjects affected / exposed
    5 / 22 (22.73%)
         occurrences all number
    5
    nail changes
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jun 2021
    Exploratory analysis of cytokine profile in HNSCC patients treated with docetaxel and pembrolizumab It has been published recently, that serum cytokine levels are altered in HNSCC patients and correlate with disease progression1. Apart from that, it there is growing evidence that not only cytokines such as interferon gamma but also soluble PD-L1 levels are of prognostic and predictive value in patients treated with CPI2,3. Based on this recent evidence we propose a retrospective exploratory analysis of the serum samples collected within the Pem-Doc study prior to publication in order to better understand the treatment responses. In particular we plan to measure the serum levels of interferon gamma; Interleukin 6, interleukin 17A, soluble PD-L1, major-histocompatibility-complex (MHC) class I-related chain genes A and B employing a ProcartaPlex 6-plex immunoassay. Soluble serum parameters will be quantified at baseline and at the initial restaging for patients with disease control and non-responders. Potential differences between paired data will be calculated using Wilcoxon signed-rank tests. Since this is a retrospective exploratory analysis of stored serum samples there will be no additional risks for the remaining patients. Next generation sequencing As already described in the protocol next generation sequencing will be performed. However, the Oncomine Comprehensive Assay v3 (Thermo Fisher Scientific, Waltham, MA, USA) instead of the Qiagen Comprehensive Cancer GeneRead DNAseq Targeted Panel will be used, since this assay is the one currently employed (for routine purposes as well) at the Department of Pathology due to superior performance.

    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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