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    Clinical Trial Results:
    Postoperative adjuvant radiochemotherapy (aRCH) with Cisplatin (C) versus aRCH with C and Pembrolizumab (P) in locally advanced head and neck squamous cell carcinoma (HNSCC); multicenter randomized Phase II study within the German interdisciplinary study group of German Cancer Society (IAG KHT); Pembro-Adjuvant-highRisk

    Summary
    EudraCT number
    		 2017-002546-74
    Trial protocol
    		 DE  
    Global end of trial date
    30 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 May 2026
    First version publication date
    01 May 2026
    Other versions
    Summary report(s)
    		 ADRISK_Ergebnisbericht_final_2026-01-19_publish

    Trial information

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    Trial identification
    Sponsor protocol code
    ADRISK
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03480672
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Leipzig University
    Sponsor organisation address
    Ritterstr. 26, Leipzig, Germany,
    Public contact
    Anett Schmiedeknecht, Leipzig University, andreas.dietz@medizin.uni-leipzig.de
    Scientific contact
    Andreas Dietz, Leipzig University, andreas.dietz@medizin.uni-leipzig.de
    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
    23 Jul 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jan 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To show that addition of Pembrolizumab (P) to postoperative adjuvant radiochemotherapy (aRCH) with Cisplatin (C) improves event free survival (EFS) compared with aRCH alone in locally advanced intermediate and high risk head and neck squamous cell carcinoma (HNSCC)
    Protection of trial subjects
    not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Aug 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 211
    Worldwide total number of subjects
    211
    EEA total number of subjects
    211
    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)
    144
    From 65 to 84 years
    67
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From 2018-08-06 to 2023-11-30 a total of 220 patients were registered to the trial, from which 211 were randomised.

    Pre-assignment
    Screening details
    		 From 2018-08-06 to 2023-11-30 a total of 220 patients were registered to the trial, from which 211 were randomised.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PaRCH
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    Keytruda
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg per infusion, in 3-week cycle, applied in maximally 18 cyles within the 1st year of trial in combination with standard radiochemotherapy (aRCH) - see Arm 2

    Arm title
    		 aRCH
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    aRCH
    Investigational medicinal product code
    Other name
    Cisplatin, Carboplatin, Radiotherapy
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    • standard treatment (adjuvant radio-chemotherapy): Radiotherapy: standard adjuvant radiotherapy (e.g., pN0 50 Gy; pN1 56 Gy; pECS + primary 66 Gy) Chemotherapy: (according to the respective standard of the trial site) - Cisplatin cumulative dose 300 mg/m2 body surface according to Cooper/Bernier (Cooper et al. 2004; Bernier et al. 2004), or - Cisplatin cumulative dose: 280 mg/m2 body surface, e.g., Cisplatin 40 mg/m2 iv, weekly in 1-7th week of treatment In the case of a cisplatin intolerance (e.g., resulting in relevantly impaired function of kidneys) during aRCH, it was possible to switch to carboplatin

    Number of subjects in period 1 [1]
    		PaRCH aRCH
    Started
    102
    102
    Completed
    102
    102
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: In FAS only patients considered who started treatment according to trial protocol.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PaRCH
    Reporting group description
    		 -

    Reporting group title
    aRCH
    Reporting group description
    		 -

    Reporting group values
    		 PaRCH aRCH Total
    Number of subjects
    		 102 102 204
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.6 ( 8.4 ) 59.8 ( 8.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 21 17 38
        Male
    		 81 85 166
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    only patients with treatment considered according to clinical trial protocol

    Subject analysis sets values
    		 FAS
    Number of subjects
    204
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    60.2 ( 8.5 )
    Gender categorical
    Units: Subjects
        Female
    38
        Male
    166

    End points

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

    Reporting group title
    aRCH
    Reporting group description
    		 -

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    only patients with treatment considered according to clinical trial protocol

    Primary: Event Free Survival (EFS)

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    End point title
    		 Event Free Survival (EFS)
    End point description
    End point type
    Primary
    End point timeframe
    EFS - time from randomization to the first event, i.e.: locoregional or distant recurrence occurrence of further malignoma death from any cause, or initiation of a new anti-cancer treatment without a previous EP-event
    End point values
    		 PaRCH aRCH
    Number of subjects analysed
    102
    102
    Units: month
        number (confidence interval 95%)
    69.4 (60.3 to 79.9)
    64.8 (55.7 to 75.5)
    Statistical analysis title
    		 Confirmatory analysis
    Statistical analysis description
    Cox regression
    Comparison groups
    PaRCH v aRCH
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.423
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.812
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.487
         upper limit
    		 1.353

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From time of first intervention (day 1) until 90 days following cessation of pembrolizumab treatment, or up to initiation of a new anti-cancer treatment whichever is earlier. In control arm documentation must be to month 3 (1st efficacy Follow-up).
    Adverse event reporting additional description
    Details - see attached final trial report: ADRISK_Ergebnisbericht_final_2026-01-19_publish
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Details - see attached final trial report: ADRISK_Ergebnisbericht_final_2026-01-19_publish

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Feb 2019
    Changes in patient informed consent (e.g., new side effects and changes in the frequency of side effects) and minor changes at trial protocol --> according to the sponsor's assessment without relevance for safety or efficacy
    12 Jul 2019
    Changes in patient informed consent (e.g., new side effects and changes in the frequency of side effects) and minor changes at trial protocol --> according to the sponsor's assessment without relevance for safety or efficacy
    14 Oct 2020
    Changes in patient informed consent (e.g., new side effects and changes in the frequency of side effects; change to data protection section due to new requirements) and minor changes in the trial protocol (e.g., prolongation of the recruitment time; more detailed explanation of time lines in visit schedule) --> according to the sponsor's assessment without relevance for safety or efficacy
    27 May 2021
    Changes in patient informed consent (e.g., new side effects and changes in the frequency of side effects) and minor changes at trial protocol (e.g., clearer definition of the starting of reporting period/obligation of AE/SAE; primary endpoint events were specified on the basis of the experience gained during the course of the trial) --> according to the sponsor's assessment without relevance for safety or efficacy
    09 Jun 2022
    Changes in trial protocol: Prolongation of recruitment time
    10 Jul 2023
    Changes in patient informed consent (e.g., new side effects and changes in the frequency of side effects) and changes at trial protocol (e.g., a shortened follow-up period for the last patients due to premature end of the trial) --> according to the sponsor's assessment without relevance for safety or efficacy

    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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