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    Clinical Trial Results:
    Randomized, controlled, open label, multicenter, phase II study to evaluate the efficacy and safety of CetuGEX plus chemotherapy in comparison to cetuximab plus chemotherapy for the treatment of patients with stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck

    Summary
    EudraCT number
    		 2013-003695-13
    Trial protocol
    		 DE   ES   IT   BE   PL  
    Global end of trial date
    04 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2020
    First version publication date
    16 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GEXMab52201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02052960
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Glycotope GmbH
    Sponsor organisation address
    Robert-Roessle-Str.10, Berlin, Germany, 13125
    Public contact
    Dr. Isabelle Ahrens-Fath, Glycotope GmbH, +49 30 94892610, Isabelle.Ahrens-Fath@glycotope.com
    Scientific contact
    Dr. Isabelle Ahrens-Fath, Glycotope GmbH, +49 30 94892610, Isabelle.Ahrens-Fath@glycotope.com
    Sponsor organisation name
    Glycotope GmbH
    Sponsor organisation address
    Robert Roessle St 10, Berlin, Germany, 13125
    Public contact
    Reception desk, Glycotope GmbH, +49 3094892600, Trials@glycotope.com
    Scientific contact
    Reception desk, Glycotope GmbH, +49 3094892600, Trials@glycotope.com
    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
    16 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Oct 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of CetuGEX™ for the treatment of patients with stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) as compared to cetuximab (both in combination with platinum-based chemotherapy) in terms of progression-free survival (PFS).
    Protection of trial subjects
    An independent DSMB was established, whose task was to review periodically the relevant safety data and provide advice on the continuation, modification or termination of the study. The DSMB comprised 3 members, 2 of them being oncologists and 1 of them a statistician. A study-specific charter defined in detail the composition, responsibilities, and procedures of the DSMB (Appendix 16.1.1). As soon as at least 10 patients per treatment arm had completed the second cycle of first line treatment, a first meeting of DSMB was scheduled to review the patient safety data. After this, regular 6-monthly meetings were scheduled until all ongoing patients had been treated for at least 6 months. Starting at the second DSMB meeting, in addition to review of patient safety data a descriptive analysis on progression and survival was included to monitor a potential detrimental effect of the IMP. For important reasons, additional meetings could be scheduled by the coordinating investigator, sponsor, medical monitor, or DSMB members for as long as patients were at risk.
    Background therapy
    		 Eligible patients were randomized to receive as first line treatment either CetuGEX™ or cetuximab in combination with chemotherapy (5-FU and cisplatin) for the maximum duration of 6 cycles of combined treatment. In case of toxicity, chemotherapy could be dose reduced, discontinued or, if later than the first cycle, switched to carboplatin. Single-agent maintenance therapy was continued with an unchanged dosing schedule until progression of disease or limiting toxicity
    Evidence for comparator
    		 Cetuximab (Erbitux®) is a chimeric immunoglobulin G (IgG) 1 mouse-human antibody targeted against the extracellular domain of the epidermal growth factor receptor (EGFR) with high specificity and affinity and is produced in the murine myeloma cell line SP2/0. Cetuximab is approved for use in combination with radiation therapy for treating squamous cell carcinoma of the head and neck (SCCHN) or in combination with platinum-based chemotherapy and 5-fluorouracil (5-FU) for the treatment of recurrent and/or metastatic SCCHN.
    Actual start date of recruitment
    27 Feb 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 24 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 58
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    France: 44
    Country: Number of subjects enrolled
    Germany: 62
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Romania: 43
    Worldwide total number of subjects
    240
    EEA total number of subjects
    240
    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)
    177
    From 65 to 84 years
    63
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 27 Feb 2014 and 25 Jan 2016 a total of 321 patients (100.0%) were screened. Date of first enrollment: 27 Feb 2014

    Pre-assignment
    Screening details
    		 Patients aged at least 18 years, with histologically confirmed recurrent and/or metastatic SCCHN not eligible for local treatment were enrolled in this study.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CetuGEX
    Arm description
    		 CetuGEX™, chimeric monoclonal immunoglobulin G (IgG) antibody with fully human glycosylation; solution for intravenous infusion, provided in single-use vials.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CetuGEX
    Investigational medicinal product code
    Other name
    Tomuzotuximab
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The IMP CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly, starting with Day 0. Starting with the second infusion (Day 8 of Cycle 1), a time window of ± 1 day was allowed for the weekly infusions (calculated from the previous infusion). The initial dose was 990 mg and subsequent doses were 720 mg once weekly. The initial loading dose was given as split-dose over 2 days with a priming dose of 60 mg on Day 0 diluted to a total volume of 100 mL (administered over 2 hours with a 30-minute break) and the remaining dose of 930 mg on Day 1 diluted to a total volume 500 mL (the intravenous infusion lasted for approximately 4 hours).

    Arm title
    		 Cetuximab
    Arm description
    		 Cetuximab, chimeric monoclonal IgG antibody; solution for intravenous infusion, provided in single-use vials.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    SUB31982
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm. Starting with the second infusion (Day 8 of Cycle 1), a time window of ± 1 day was allowed for the weekly infusions (calculated from the previous infusion). The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA. The maximum Infusion rate for the initial dose could not exceed 5 mg/min. The maximum infusion rate for subsequent doses could not exceed 10 mg/min. The BSA was calculated using the Mosteller formula: BSA [m2] = (Weight [kg] × Height [cm]/3600)½

    Number of subjects in period 1
    		CetuGEX Cetuximab
    Started
    117
    123
    Completed
    59
    74
    Not completed
    58
    49
         Consent withdrawn by subject
    6
    11
         Adverse event, non-fatal
    19
    17
         still on treatment
    4
    3
         unspecified
    25
    15
         Protocol deviation
    4
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CetuGEX
    Reporting group description
    		 CetuGEX™, chimeric monoclonal immunoglobulin G (IgG) antibody with fully human glycosylation; solution for intravenous infusion, provided in single-use vials.

    Reporting group title
    Cetuximab
    Reporting group description
    		 Cetuximab, chimeric monoclonal IgG antibody; solution for intravenous infusion, provided in single-use vials.

    Reporting group values
    		 CetuGEX Cetuximab Total
    Number of subjects
    		 117 123 240
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 88 89 177
        From 65-84 years
    		 29 34 63
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.8 ( 7.54 ) 59.8 ( 7.91 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 17 35
        Male
    		 99 106 205
    Subject analysis sets

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population (SAF) included all patients who received at least one dose of trial medication. This population was used for safety analyses.

    Subject analysis set title
    Intent to treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population consisted of all randomized patients. The ITT population was the primary population for the efficacy analysis.

    Subject analysis sets values
    		 Safety population Intent to treat population
    Number of subjects
    237
    240
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    177
        From 65-84 years
    63
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    59.8 ( 7.72 )
    Gender categorical
    Units: Subjects
        Female
    35
        Male
    205

    End points

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    End points reporting groups
    Reporting group title
    CetuGEX
    Reporting group description
    		 CetuGEX™, chimeric monoclonal immunoglobulin G (IgG) antibody with fully human glycosylation; solution for intravenous infusion, provided in single-use vials.

    Reporting group title
    Cetuximab
    Reporting group description
    		 Cetuximab, chimeric monoclonal IgG antibody; solution for intravenous infusion, provided in single-use vials.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population (SAF) included all patients who received at least one dose of trial medication. This population was used for safety analyses.

    Subject analysis set title
    Intent to treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population consisted of all randomized patients. The ITT population was the primary population for the efficacy analysis.

    Primary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    The primary objective of the study was to evaluate the efficacy of CetuGEX™ for the treatment of patients with stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) as compared to cetuximab (both in combination with platinum-based chemotherapy) in terms of progression-free survival (PFS).
    End point type
    Primary
    End point timeframe
    The PFS was defined as time from randomization until disease progression or death of any cause.
    End point values
    		 CetuGEX Cetuximab
    Number of subjects analysed
    117
    123
    Units: weeks
        median (confidence interval 95%)
    27.571 (23.429 to 33.571)
    26.429 (24.714 to 31.286)
    Statistical analysis title
    		 Log-Rank Test and Kaplan-Meier Analysis
    Comparison groups
    CetuGEX v Cetuximab
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8167
    Method
    		 Logrank
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    Objective response rate is the portion of patients with a tumor size reduction of a predefined amount for a minimum time period and it is defined as the sum of partial responses and complete responses.
    End point type
    Secondary
    End point timeframe
    Time from randomization until disease progression or death, whichever occurs first
    End point values
    		 CetuGEX Cetuximab
    Number of subjects analysed
    117
    123
    Units: patients
    52
    57
    Statistical analysis title
    		 Chi-square test
    Comparison groups
    CetuGEX v Cetuximab
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.768
    Method
    		 Chi-squared
    Parameter type
    		 rate difference
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.5
         upper limit
    		 10.7

    Secondary: Clinical Benefit Rate

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    End point title
    		 Clinical Benefit Rate
    End point description
    The clinical benefit rate is the portion of patients with an objective response or stable disease.
    End point type
    Secondary
    End point timeframe
    Time from randomization until disease progression or death, whichever occurs first. SD: follow-up measurements must have met the SD criteria at least once after randomization at a minimum interval of 8 weeks
    End point values
    		 CetuGEX Cetuximab
    Number of subjects analysed
    117
    123
    Units: Subjects
    88
    94
    Statistical analysis title
    		 Chi-square test
    Comparison groups
    Cetuximab v CetuGEX
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8269
    Method
    		 Chi-squared
    Parameter type
    		 rate difference
    Point estimate
    -1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.05
         upper limit
    		 9.63

    Secondary: Response duration

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    End point title
    		 Response duration
    End point description
    Duration of response, defined as the interval between the date of first response and the date of first progression (modified irRC) or death
    End point type
    Secondary
    End point timeframe
    Response duration is measured from the time of initial response until documented tumor progression.
    End point values
    		 CetuGEX Cetuximab
    Number of subjects analysed
    52
    57
    Units: weeks
        median (confidence interval 95%)
    26.143 (21.571 to 34.857)
    30.143 (24.286 to 37.000)
    Statistical analysis title
    		 Log-Rank Test and Kaplan-Meier Analysis
    Comparison groups
    CetuGEX v Cetuximab
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8663
    Method
    		 Logrank
    Confidence interval

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    The overall survival is defined as the duration of time from randomization to the time of death.
    End point type
    Secondary
    End point timeframe
    Duration of time from randomization to the time of death.
    End point values
    		 CetuGEX Cetuximab
    Number of subjects analysed
    117
    123
    Units: weeks
        median (confidence interval 95%)
    49.714 (40.714 to 73.857)
    59.000 (52.857 to 70.286)
    Statistical analysis title
    		 Log-Rank Test and Kaplan-Meier Analysis
    Comparison groups
    CetuGEX v Cetuximab
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9616
    Method
    		 Logrank
    Confidence interval

    Secondary: Time to treatment failure

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    End point title
    		 Time to treatment failure
    End point description
    Time to treatment failure is defined as the time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death
    End point type
    Secondary
    End point timeframe
    Time to treatment failure, defined as the interval between the date of randomization and the date of treatment discontinuation for any reason
    End point values
    		 CetuGEX Cetuximab
    Number of subjects analysed
    116
    123
    Units: weeks
        median (confidence interval 95%)
    22.143 (17.000 to 25.714)
    23.286 (16.143 to 25.571)
    Statistical analysis title
    		 Log-Rank Test and Kaplan-Meier Analysis
    Comparison groups
    CetuGEX v Cetuximab
    Number of subjects included in analysis
    239
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7038
    Method
    		 Logrank
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from the time of signing the ICF through the Safety Follow-Up Visit performed for all patients at 28 days (+ 2 days) after the last dose administered.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    		 The safety population included all patients who received at least 1 dose of trial medication. This population was used for safety analyses.

    Reporting group title
    CetuGEX Safety population
    Reporting group description
    		 -

    Reporting group title
    Cetuximab Safety population
    Reporting group description
    		 -

    Serious adverse events
    		 Safety population CetuGEX Safety population Cetuximab Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    148 / 237 (62.45%)
    70 / 115 (60.87%)
    78 / 122 (63.93%)
         number of deaths (all causes)
    34
    20
    14
         number of deaths resulting from adverse events
    34
    20
    14
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    5 / 237 (2.11%)
    2 / 115 (1.74%)
    3 / 122 (2.46%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    5 / 237 (2.11%)
    3 / 115 (2.61%)
    2 / 122 (1.64%)
         occurrences causally related to treatment / all
    3 / 5
    3 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    3 / 237 (1.27%)
    2 / 115 (1.74%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    3 / 237 (1.27%)
    2 / 115 (1.74%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    18 / 237 (7.59%)
    9 / 115 (7.83%)
    9 / 122 (7.38%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Neutropenia
         subjects affected / exposed
    15 / 237 (6.33%)
    8 / 115 (6.96%)
    7 / 122 (5.74%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    6 / 237 (2.53%)
    2 / 115 (1.74%)
    4 / 122 (3.28%)
         occurrences causally related to treatment / all
    5 / 9
    2 / 2
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    5 / 237 (2.11%)
    3 / 115 (2.61%)
    2 / 122 (1.64%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    5 / 237 (2.11%)
    1 / 115 (0.87%)
    4 / 122 (3.28%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    4 / 237 (1.69%)
    2 / 115 (1.74%)
    2 / 122 (1.64%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    1 / 4
    1 / 2
    0 / 2
    General physical health deterioration
         subjects affected / exposed
    4 / 237 (1.69%)
    2 / 115 (1.74%)
    2 / 122 (1.64%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Device dislocation
         subjects affected / exposed
    3 / 237 (1.27%)
    1 / 115 (0.87%)
    2 / 122 (1.64%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    3 / 237 (1.27%)
    2 / 115 (1.74%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    3 / 237 (1.27%)
    3 / 115 (2.61%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 237 (2.11%)
    3 / 115 (2.61%)
    2 / 122 (1.64%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    5 / 237 (2.11%)
    3 / 115 (2.61%)
    2 / 122 (1.64%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    4 / 237 (1.69%)
    2 / 115 (1.74%)
    2 / 122 (1.64%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    5 / 237 (2.11%)
    2 / 115 (1.74%)
    3 / 122 (2.46%)
         occurrences causally related to treatment / all
    4 / 5
    2 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    3 / 237 (1.27%)
    2 / 115 (1.74%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Renal failure acute
         subjects affected / exposed
    3 / 237 (1.27%)
    1 / 115 (0.87%)
    2 / 122 (1.64%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    21 / 237 (8.86%)
    12 / 115 (10.43%)
    9 / 122 (7.38%)
         occurrences causally related to treatment / all
    10 / 25
    6 / 15
    4 / 10
         deaths causally related to treatment / all
    0 / 8
    0 / 6
    0 / 2
    Sepsis
         subjects affected / exposed
    10 / 237 (4.22%)
    3 / 115 (2.61%)
    7 / 122 (5.74%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 3
    1 / 7
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    1 / 2
    Device related infection
         subjects affected / exposed
    9 / 237 (3.80%)
    5 / 115 (4.35%)
    4 / 122 (3.28%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    3 / 237 (1.27%)
    0 / 115 (0.00%)
    3 / 122 (2.46%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    9 / 237 (3.80%)
    4 / 115 (3.48%)
    5 / 122 (4.10%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    9 / 237 (3.80%)
    4 / 115 (3.48%)
    5 / 122 (4.10%)
         occurrences causally related to treatment / all
    8 / 9
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    7 / 237 (2.95%)
    3 / 115 (2.61%)
    4 / 122 (3.28%)
         occurrences causally related to treatment / all
    4 / 10
    1 / 5
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    5 / 237 (2.11%)
    2 / 115 (1.74%)
    3 / 122 (2.46%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety population CetuGEX Safety population Cetuximab Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    235 / 237 (99.16%)
    114 / 115 (99.13%)
    121 / 122 (99.18%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    32 / 237 (13.50%)
    16 / 115 (13.91%)
    16 / 122 (13.11%)
         occurrences all number
    44
    20
    24
    Hypertension
         subjects affected / exposed
    19 / 237 (8.02%)
    11 / 115 (9.57%)
    8 / 122 (6.56%)
         occurrences all number
    43
    30
    13
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    79 / 237 (33.33%)
    41 / 115 (35.65%)
    38 / 122 (31.15%)
         occurrences all number
    163
    82
    81
    Asthenia
         subjects affected / exposed
    71 / 237 (29.96%)
    34 / 115 (29.57%)
    37 / 122 (30.33%)
         occurrences all number
    135
    60
    75
    Mucosal inflammation
         subjects affected / exposed
    60 / 237 (25.32%)
    24 / 115 (20.87%)
    36 / 122 (29.51%)
         occurrences all number
    108
    45
    63
    Pyrexia
         subjects affected / exposed
    40 / 237 (16.88%)
    16 / 115 (13.91%)
    24 / 122 (19.67%)
         occurrences all number
    47
    17
    30
    Chills
         subjects affected / exposed
    32 / 237 (13.50%)
    26 / 115 (22.61%)
    6 / 122 (4.92%)
         occurrences all number
    34
    28
    6
    General physical health deterioration
         subjects affected / exposed
    13 / 237 (5.49%)
    7 / 115 (6.09%)
    6 / 122 (4.92%)
         occurrences all number
    16
    10
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    25 / 237 (10.55%)
    10 / 115 (8.70%)
    15 / 122 (12.30%)
         occurrences all number
    31
    10
    21
    Dyspnoea
         subjects affected / exposed
    25 / 237 (10.55%)
    11 / 115 (9.57%)
    14 / 122 (11.48%)
         occurrences all number
    33
    17
    16
    Epistaxis
         subjects affected / exposed
    16 / 237 (6.75%)
    6 / 115 (5.22%)
    10 / 122 (8.20%)
         occurrences all number
    20
    7
    13
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    12 / 237 (5.06%)
    8 / 115 (6.96%)
    4 / 122 (3.28%)
         occurrences all number
    18
    13
    5
    Investigations
    Weight decreased
         subjects affected / exposed
    81 / 237 (34.18%)
    42 / 115 (36.52%)
    39 / 122 (31.97%)
         occurrences all number
    155
    83
    72
    Blood creatinine increased
         subjects affected / exposed
    19 / 237 (8.02%)
    11 / 115 (9.57%)
    8 / 122 (6.56%)
         occurrences all number
    34
    19
    15
    Platelet count decreased
         subjects affected / exposed
    13 / 237 (5.49%)
    7 / 115 (6.09%)
    6 / 122 (4.92%)
         occurrences all number
    19
    13
    6
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    13 / 237 (5.49%)
    10 / 115 (8.70%)
    3 / 122 (2.46%)
         occurrences all number
    14
    11
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    29 / 237 (12.24%)
    14 / 115 (12.17%)
    15 / 122 (12.30%)
         occurrences all number
    36
    16
    20
    Headache
         subjects affected / exposed
    26 / 237 (10.97%)
    13 / 115 (11.30%)
    13 / 122 (10.66%)
         occurrences all number
    35
    16
    19
    Neuropathy peripheral
         subjects affected / exposed
    12 / 237 (5.06%)
    3 / 115 (2.61%)
    9 / 122 (7.38%)
         occurrences all number
    23
    4
    19
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    100 / 237 (42.19%)
    44 / 115 (38.26%)
    56 / 122 (45.90%)
         occurrences all number
    256
    104
    152
    Neutropenia
         subjects affected / exposed
    98 / 237 (41.35%)
    47 / 115 (40.87%)
    51 / 122 (41.80%)
         occurrences all number
    229
    105
    124
    Leukopenia
         subjects affected / exposed
    70 / 237 (29.54%)
    33 / 115 (28.70%)
    37 / 122 (30.33%)
         occurrences all number
    188
    98
    90
    Thrombocytopenia
         subjects affected / exposed
    47 / 237 (19.83%)
    21 / 115 (18.26%)
    26 / 122 (21.31%)
         occurrences all number
    117
    48
    69
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    23 / 237 (9.70%)
    11 / 115 (9.57%)
    12 / 122 (9.84%)
         occurrences all number
    25
    13
    12
    Tinnitus
         subjects affected / exposed
    14 / 237 (5.91%)
    8 / 115 (6.96%)
    6 / 122 (4.92%)
         occurrences all number
    17
    10
    7
    Hearing impaired
         subjects affected / exposed
    13 / 237 (5.49%)
    6 / 115 (5.22%)
    7 / 122 (5.74%)
         occurrences all number
    14
    6
    8
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    19 / 237 (8.02%)
    10 / 115 (8.70%)
    9 / 122 (7.38%)
         occurrences all number
    28
    16
    12
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    121 / 237 (51.05%)
    58 / 115 (50.43%)
    63 / 122 (51.64%)
         occurrences all number
    284
    122
    162
    Diarrhoea
         subjects affected / exposed
    79 / 237 (33.33%)
    38 / 115 (33.04%)
    41 / 122 (33.61%)
         occurrences all number
    157
    73
    84
    Vomiting
         subjects affected / exposed
    76 / 237 (32.07%)
    35 / 115 (30.43%)
    41 / 122 (33.61%)
         occurrences all number
    150
    67
    83
    Constipation
         subjects affected / exposed
    57 / 237 (24.05%)
    34 / 115 (29.57%)
    23 / 122 (18.85%)
         occurrences all number
    87
    47
    40
    Stomatitis
         subjects affected / exposed
    38 / 237 (16.03%)
    26 / 115 (22.61%)
    12 / 122 (9.84%)
         occurrences all number
    87
    66
    21
    Dysphagia
         subjects affected / exposed
    31 / 237 (13.08%)
    15 / 115 (13.04%)
    16 / 122 (13.11%)
         occurrences all number
    42
    20
    22
    Dyspepsia
         subjects affected / exposed
    28 / 237 (11.81%)
    15 / 115 (13.04%)
    13 / 122 (10.66%)
         occurrences all number
    42
    23
    19
    Abdominal pain
         subjects affected / exposed
    19 / 237 (8.02%)
    7 / 115 (6.09%)
    12 / 122 (9.84%)
         occurrences all number
    30
    17
    13
    Abdominal pain upper
         subjects affected / exposed
    15 / 237 (6.33%)
    9 / 115 (7.83%)
    6 / 122 (4.92%)
         occurrences all number
    17
    11
    6
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    91 / 237 (38.40%)
    44 / 115 (38.26%)
    47 / 122 (38.52%)
         occurrences all number
    243
    116
    127
    Dermatitis acneiform
         subjects affected / exposed
    51 / 237 (21.52%)
    30 / 115 (26.09%)
    21 / 122 (17.21%)
         occurrences all number
    170
    106
    64
    Dry skin
         subjects affected / exposed
    43 / 237 (18.14%)
    20 / 115 (17.39%)
    23 / 122 (18.85%)
         occurrences all number
    49
    23
    26
    Skin fissures
         subjects affected / exposed
    36 / 237 (15.19%)
    19 / 115 (16.52%)
    17 / 122 (13.93%)
         occurrences all number
    74
    38
    36
    Acne
         subjects affected / exposed
    21 / 237 (8.86%)
    10 / 115 (8.70%)
    11 / 122 (9.02%)
         occurrences all number
    63
    23
    40
    Alopecia
         subjects affected / exposed
    20 / 237 (8.44%)
    9 / 115 (7.83%)
    11 / 122 (9.02%)
         occurrences all number
    23
    10
    13
    Erythema
         subjects affected / exposed
    16 / 237 (6.75%)
    8 / 115 (6.96%)
    8 / 122 (6.56%)
         occurrences all number
    18
    8
    10
    Pruritus
         subjects affected / exposed
    14 / 237 (5.91%)
    10 / 115 (8.70%)
    4 / 122 (3.28%)
         occurrences all number
    22
    16
    6
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    16 / 237 (6.75%)
    5 / 115 (4.35%)
    11 / 122 (9.02%)
         occurrences all number
    23
    7
    16
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    13 / 237 (5.49%)
    6 / 115 (5.22%)
    7 / 122 (5.74%)
         occurrences all number
    17
    9
    8
    Infections and infestations
    Paronychia
         subjects affected / exposed
    28 / 237 (11.81%)
    16 / 115 (13.91%)
    12 / 122 (9.84%)
         occurrences all number
    55
    36
    19
    Pneumonia
         subjects affected / exposed
    25 / 237 (10.55%)
    13 / 115 (11.30%)
    12 / 122 (9.84%)
         occurrences all number
    31
    17
    14
    Urinary tract infection
         subjects affected / exposed
    13 / 237 (5.49%)
    7 / 115 (6.09%)
    6 / 122 (4.92%)
         occurrences all number
    19
    12
    7
    Bronchitis
         subjects affected / exposed
    12 / 237 (5.06%)
    3 / 115 (2.61%)
    9 / 122 (7.38%)
         occurrences all number
    17
    3
    14
    Device related infection
         subjects affected / exposed
    12 / 237 (5.06%)
    8 / 115 (6.96%)
    4 / 122 (3.28%)
         occurrences all number
    13
    8
    5
    Sepsis
         subjects affected / exposed
    12 / 237 (5.06%)
    4 / 115 (3.48%)
    8 / 122 (6.56%)
         occurrences all number
    12
    4
    8
    Metabolism and nutrition disorders
    Hypomagnesaemia
         subjects affected / exposed
    104 / 237 (43.88%)
    53 / 115 (46.09%)
    51 / 122 (41.80%)
         occurrences all number
    327
    146
    181
    Decreased appetite
         subjects affected / exposed
    66 / 237 (27.85%)
    36 / 115 (31.30%)
    30 / 122 (24.59%)
         occurrences all number
    95
    47
    48
    Hypokalaemia
         subjects affected / exposed
    42 / 237 (17.72%)
    20 / 115 (17.39%)
    22 / 122 (18.03%)
         occurrences all number
    88
    35
    53
    Dehydration
         subjects affected / exposed
    23 / 237 (9.70%)
    10 / 115 (8.70%)
    13 / 122 (10.66%)
         occurrences all number
    25
    11
    14
    Hypocalcaemia
         subjects affected / exposed
    23 / 237 (9.70%)
    10 / 115 (8.70%)
    13 / 122 (10.66%)
         occurrences all number
    39
    19
    20
    Hyponatraemia
         subjects affected / exposed
    20 / 237 (8.44%)
    11 / 115 (9.57%)
    9 / 122 (7.38%)
         occurrences all number
    23
    14
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Feb 2015
    Modification to the inclusion criteria such that patients with squamous cell carcinoma of the head and neck could be included irrespective of their EGFR status, rather than restricting inclusion to EGFR-positive patients. In addition, patients’ p16 status was removed from the stratification criteria. The EGFR status was added as a subgroup for analysis of secondary endpoints, and an exploration of the effects of both EGFR status and p16 status was added to the sensitivity analyses.

    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
    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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