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    Clinical Trial Results:
    Frail-Immune (GORTEC-2018-03) - A multicenter, prospective, single arm phase II study evaluating the efficacy and safety of the combination of Durvalumab with carboplatin and paclitaxel as first line treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck not eligible to standard chemotherapy

    Summary
    EudraCT number
    		 2018-000414-38
    Trial protocol
    		 FR  
    Global end of trial date
    09 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Dec 2025
    First version publication date
    25 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ET18-023
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Léon Bérard
    Sponsor organisation address
    28 Rue Laënnec, Lyon, France,
    Public contact
    Dr Jérôme FAYETTE, Centre Léon Bérard, 33 0478782828, jerome.fayette@lyon.unicancer.fr
    Scientific contact
    Dr Jérôme FAYETTE, Centre Léon Bérard, 33 0478782828, jerome.fayette@lyon.unicancer.fr
    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
    26 Apr 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Mar 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Run-in safety phase The primary objective of the run-in safety study is to evaluate the safety of the combination of Durvalumab with the Carboplatin/Paclitaxel in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy. Tolerance will be determined according to the onset of limiting adverse events at the end of the first cycle of chemotherapy (4 weeks and up to 6 weeks).
    Protection of trial subjects
    Study treatments will continue to be administered as long as patient experiences clinical benefit. The investigator will have to inform the patient of the study treatment, the objectives and the design of the study, provide the patient information leaflet / Informed consent form, answer to any questions that the patient may have and ensure that she understands the potential risks and benefits of participating in the study before signing the informed consent form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 May 2019
    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
    France: 104
    Worldwide total number of subjects
    104
    EEA total number of subjects
    104
    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)
    104
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 the screening period : Inform the patient about the treatments, objectives, outcome and any ancillary studies, answer their questions and sign the informed consent with them after a reflection period of at least 24 hours. Check the eligibility criteria list and perform the exams (e.g. Physicial examination, baseline signs and symptoms...)

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

    Arms
    Arm title
    		 Single Arm
    Arm description
    		 Combination of Durvalumab (MEDI4736) with carboplatin and paclitaxel. Patients may continue treatment with study drug until the end of the 4th cycle or until the patient experiences unacceptable toxicity, disease progression and/or treatment is discontinued per patient request or at the discretion of the investigator.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel and carboplatin will be administered at room temperature (approximately 25°C) by controlled intravenous infusion. At the first cycle only, paclitaxel and carboplatin will be administered the day after durvalumab; it will be considered as the Day 1 of the first cycle (Cycle 1 Day 1). Carboplatin should be administered intravenously in 250ml Glucose 5% over 30-60 minutes.

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel and carboplatin will be administered at room temperature (approximately 25°C) by controlled intravenous infusion. At the first cycle only, paclitaxel and carboplatin will be administered the day after durvalumab; it will be considered as the Day 1 of the first cycle (Cycle 1 Day 1). Paclitaxel should be administered intravenously in 250ml Sodium Chloride 0.9% or Glucose 5% over 1 hour (±5 minutes) via non-PVC infusion bag, with a 0.22 micron in-line filter. Paclitaxel must be diluted to a concentration of 0.3-1.2mg/ml to maintain stability in clinical practice.

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Duration : Up to 1 year (maximum of 13 durvalumab administrations) with the last administration on week 48, unless a criterion for early discontinuation is met first. For the first cycle, durvalumab will be administered the day before the first infusion of paclitaxel then carboplatin; it will be considered as the Cycle 1 Day 0. For the subsequent cycles, Durvalumab will be first administered, then paclitaxel and finally carboplatin Durvalumab will be administered at room temperature (approximately 25°C) by controlled intravenous infusion. The number of vials needed for each patient is 3 vials per injection day for a total dose of 1500mg, Q4W. Following preparation of Durvalumab, the entire contents of the IV bag should be administered as an IV infusion over approximately 60 minutes (±5 minutes), using a 0.2 or 0.22 μm in-line filter.

    Number of subjects in period 1
    		Single Arm
    Started
    104
    Completed
    104

    Baseline characteristics

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

    Reporting group values
    		 Overrall period Total
    Number of subjects
    		 104 104
    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)
    		 54 54
        From 65-84 years
    		 50 50
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 68.5 (50.0 to 90.0) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 94 94

    End points

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    End points reporting groups
    Reporting group title
    Single Arm
    Reporting group description
    		 Combination of Durvalumab (MEDI4736) with carboplatin and paclitaxel. Patients may continue treatment with study drug until the end of the 4th cycle or until the patient experiences unacceptable toxicity, disease progression and/or treatment is discontinued per patient request or at the discretion of the investigator.

    Primary: Run-in safety phase

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    End point title
    		 Run-in safety phase [1]
    End point description
    End point type
    Primary
    End point timeframe
    The primary objective of the run-in safety study is to evaluate the safety of the combination of Durvalumab with the Carboplatin/Paclitaxel in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy.
    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: According to the A’Hern’s single-stage design used in this study with P0=47% and p1=65%, At the time of analysis, if at least 38 successes are observed among the 64 analyzed patients, the treatment will be considered as interesting for further investigation in this indication. Results: Among the 64 analysed patients, 40 pts (62.5%, 95% CI [49.5%; 74.3%]) were alive at 12 months, meaning that the efficacy rule for the primary endpoint is met.
    End point values
    		 Single Arm
    Number of subjects analysed
    64
    Units: Patients in success
    number (not applicable)
        Patients in success
    40
    No statistical analyses for this end point

    Primary: Efficacy of a combination

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    End point title
    		 Efficacy of a combination [2]
    End point description
    End point type
    Primary
    End point timeframe
    The primary objective is to determine the efficacy of a combination of Durvalumab with the Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy.
    Notes
    [2] - 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: According to the A’Hern’s single-stage design used in this study with P0=15% and p1=35%, At the time of analysis, at least 10 successes should be observed among 38 evaluable patients, to consider the treatment as interesting for further investigation in this indication. Results: Among the 40 analysed patients, 39 were evaluable for the primary endpoint and 20/39 pts (51.3%, unilateral 95% CI [37.1%; -] ) were alive at 12 months, meaning that the efficacy rule for the primary endpoint is met.
    End point values
    		 Single Arm
    Number of subjects analysed
    40
    Units: Patients in success
    number (not applicable)
        Patients in success
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The investigator collects (spontaneous patient report or questionning) and immediately notifies the sponsor of all SAEs, in a written report, wether or not theay are deemed to be attributable to research and wich occur during the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    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: Cohort B: At the time of the analysis, 28 patients (70%) had presented AEs related to durvalumab and 38 patients (95%) had presented AEs related to chemotherapy. The most frequent AEs related to durvalumab were asthenia (22.5%). The most frequent AEs related to chemotherapy were anaemia (62.5%). SAEs were reported for 26 patients (65%) Cohort A : 54 patients (84.4%) had presented AEs related to durvalumab and 62 patients (96.9%) had presented AEs related to chemotherapy. SAEs were reported for

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 May 2019
    Modifications made to the initial version following interim letters from the ANSM ; Modifications suggested following our letter of commitment; Other modifications aimed at clarifying the study documents; Addition of questionnaires for patients over 70 years of age; Update of the list of investigators;
    11 Dec 2019
    Update to the Durvalumab Investigator's Brochure (IB): Added details regarding eligibility criteria; Modified exploratory objectives; Clarifications regarding the Run-in phase; Changes to harmonize terminology; Added 2 bibliographic references; Updated list of investigators:
    17 Sep 2020
    Update to the Durvalumab Investigator brochure; Carboplatin premedication; Clarifications regarding the first treatment cycle and administration of treatments; Updated list of investigators
    13 Jul 2021
    Incorporate routine prophylaxis with G-CSF. Update to the Durvalumab Investigator's Brochure (IB) Edition 16 Added clarification by the regulatory text regarding the General Data Protection Regulation (GDPR) Update to the list of investigators
    27 Apr 2022
    Update of the Durvalumab investigator brochure Update the investigors list
    14 Sep 2022
    The extension of the duration of inclusions
    17 Jan 2023
    Changes to the definition of the study population for efficacy analysis; Clarification of the reporting period for the SAE (Synopsis Analysis and Evaluation System); Change to the version number of the synopsis.
    02 May 2023
    Changes to the recommendations for managing immune-related adverse events in the durvalumab investigator brochure ; Change of insurance company name (non-substantial modification)

    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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