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    Clinical Trial Results:
    A phase II trial to assess the safety, immunological activity of Trovax plus Pemetrexed/ Cisplatin in patients with malignant pleural mesothelioma.

    Summary
    EudraCT number
    		 2010-023230-22
    Trial protocol
    		 GB  
    Global end of trial date
    04 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jun 2017
    First version publication date
    04 Jun 2017
    Other versions
    Summary report(s)
    		 synopsis
    consort diagram

    Trial information

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    Trial identification
    Sponsor protocol code
    2010/VCC/0049
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01569919
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Velindre NHS Trust
    Sponsor organisation address
    Velindre Cancer Centre, Cardiff, United Kingdom, CF14 2TL
    Public contact
    Joanna Canham - SKOPOS Trial Manager, Wales Cancer Trials Unit - Centre for Trials Research, 02920 687581, SKOPOS@cardiff.ac.uk
    Scientific contact
    Angela Casbard - SKOPOS Senior statistician , Wales Cancer Trials Unit - Centre for Trials Research, 02920 687470, SKOPOS@cardiff.ac.uk
    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
    15 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    04 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate whether TroVax® is active in the treatment of MPM. This will be assessed by measuring the cellular or humoral anti-5T4 immune responses following treatment with TroVax® given in combination with Pem/Cis.
    Protection of trial subjects
    The trial involved the use of a genetically modified vaccine and this was reviewed and given ethical approval by the Gene Therapy Advisory Committee. Standard Operating procedures for the receipt, handling, storage, dispensing, transport, administration and disposal of the vaccine were put in place before the trial opened to protect patients and trial staff. All patients were monitored for safety and serious adverse events throughout the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Feb 2013
    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
    United Kingdom: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    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)
    10
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from Velindre Cancer Centre in Cardiff between February 2013 and December 2014.

    Pre-assignment
    Screening details
    		 Before any trial related procedures were undertaken to assess eligibility, the patient’s written informed consent was obtained. Eligible patients had locally advanced or metastatic, histologically or cytologically proven MPM and were fit to take trial treatment. 37 patients were screened, 3 were not eligibile criteria and 5 patients declined.

    Period 1
    Period 1 title
    Registration
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental
    Arm description
    		 All patients were allocated to the experimental trial treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TroVax
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants were given 9 intramuscular injections of TroVax®, starting two weeks before the commencement of chemotherapy, and continuing at regular intervals during and after chemotherapy. TroVax® is presented as lyophilised material. TroVax® was reconstituted by adding 1.2ml of water for injection (WFI). TroVax was given at a dose of 1 x 10^9 TCID 50/ml in 1ml by intramuscular injection into the deltoid muscle of the shoulder, given on Day 1 or 2 of weeks 1, 3, 6, 9, 12, 15, 18, 21, 24.

    Number of subjects in period 1
    		Experimental
    Started
    29
    Completed
    29
    Period 2
    Period 2 title
    Eligible patients
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental
    Arm description
    		 All patients were allocated to the experimental trial treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TroVax
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants were given 9 intramuscular injections of TroVax®, starting two weeks before the commencement of chemotherapy, and continuing at regular intervals during and after chemotherapy. TroVax® is presented as lyophilised material. TroVax® was reconstituted by adding 1.2ml of water for injection (WFI). TroVax was given at a dose of 1 x 10^9 TCID 50/ml in 1ml by intramuscular injection into the deltoid muscle of the shoulder, given on Day 1 or 2 of weeks 1, 3, 6, 9, 12, 15, 18, 21, 24.

    Number of subjects in period 2
    		Experimental
    Started
    29
    Completed
    23
    Not completed
    6
         Consent withdrawn by subject
    3
         Patient died
    1
         Protocol deviation
    2

    Baseline characteristics

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

    Reporting group values
    		 Registration Total
    Number of subjects
    		 29 29
    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)
    		 10 10
        From 65-84 years
    		 19 19
        85 years and over
    		 0 0
    Age continuous
    Median age of participants
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 67 (63 to 71) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 25 25
    WHO
    WHO performance status
    Units: Subjects
        WHO = 0
    		 13 13
        WHO = 1
    		 16 16
    Mesothelioma type
    Units: Subjects
        Epitheliod
    		 20 20
        Sarcomatoid
    		 5 5
        NOS (not otherwise specified)
    		 4 4
    Mesothelioma stage
    Units: Subjects
        Stage II
    		 11 11
        Stage III
    		 16 16
        Stage IV
    		 2 2
    Platelets
    Units: x 10^9/L
        median (inter-quartile range (Q1-Q3))
    		 313 (250 to 405) -
    Monocytes
    Units: x 10^9/L
        median (inter-quartile range (Q1-Q3))
    		 0.7 (0.5 to 0.8) -
    Haemoglobin
    Units: g/dl
        median (inter-quartile range (Q1-Q3))
    		 13.1 (12.7 to 14.7) -
    Subject analysis sets

    Subject analysis set title
    Per protocol analysis
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    These patients received at least the first 3 TroVax injections and at least 1st cycle of chemotherapy and were confirmed to be eligible for the trial.

    Subject analysis sets values
    		 Per protocol analysis
    Number of subjects
    23
    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)
    9
        From 65-84 years
    14
        85 years and over
    0
    Age continuous
    Median age of participants
    Units: years
        median (inter-quartile range (Q1-Q3))
    66 (61 to 70)
    Gender categorical
    Units: Subjects
        Female
    3
        Male
    20
    WHO
    WHO performance status
    Units: Subjects
        WHO = 0
    12
        WHO = 1
    11
    Mesothelioma type
    Units: Subjects
        Epitheliod
    17
        Sarcomatoid
    2
        NOS (not otherwise specified)
    4
    Mesothelioma stage
    Units: Subjects
        Stage II
    8
        Stage III
    13
        Stage IV
    2
    Platelets
    Units: x 10^9/L
        median (inter-quartile range (Q1-Q3))
    351 (250 to 407)
    Monocytes
    Units: x 10^9/L
        median (inter-quartile range (Q1-Q3))
    0.6 (0.4 to 0.8)
    Haemoglobin
    Units: g/dl
        median (inter-quartile range (Q1-Q3))
    13.8 (12.7 to 14.7)

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 All patients were allocated to the experimental trial treatment.
    Reporting group title
    Experimental
    Reporting group description
    		 All patients were allocated to the experimental trial treatment.

    Subject analysis set title
    Per protocol analysis
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    These patients received at least the first 3 TroVax injections and at least 1st cycle of chemotherapy and were confirmed to be eligible for the trial.

    Primary: Immune response to 5T4 (humoral or cellular)

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    End point title
    		 Immune response to 5T4 (humoral or cellular) [1]
    End point description
    The outcome measure is the immune response to the 5T4 antigen. A success in this trial is defined as an increased response (at least a doubling in the 5T4 antibody or T-cell response) from that measured at baseline at any of the six follow-up time points. The sample size was determined using Fleming’s single arm design. Using Fleming’s single-stage design, p1=0.40 and p2=0.64, setting alpha=0.05 (1-sided) and 80% power, 26 participants are required. If a doubling of 5T4 immune reponse is seen in at least 16 patients, then we can reject the null hypothesis that the vaccine does not elicit an immune response.
    End point type
    Primary
    End point timeframe
    The immune response is measured at six follow-up time points: after 2 injections; after 3 injections; after 4 injections; after 5 injections; after 9 injections; 10 weeks after the last injection.
    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: This Fleming's design requires a threshold number of events (n=16) to be observed. We observed 22 events. No further statistical analysis was required other than counting the number of events.
    End point values
    		 Per protocol analysis
    Number of subjects analysed
    23
    Units: subjects
        Response
    22
        Non-response
    1
    No statistical analyses for this end point

    Secondary: Progression Free Survival

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    End point title
    		 Progression Free Survival
    End point description
    PFS is defined from the time of enrolment to any disease progression and/or death, those still progression-free and alive will be censored at the date last seen.
    End point type
    Secondary
    End point timeframe
    Measured from time of randomisation to the time of progression or death, measured until the end of the trial.
    End point values
    		 Per protocol analysis
    Number of subjects analysed
    23
    Units: Months
        median (inter-quartile range (Q1-Q3))
    6.8 (3.58 to 8.9)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    The median OS (defined as the time from enrolment to death from any cause).
    End point type
    Secondary
    End point timeframe
    Measured from randomisation until up to two -years from randomisation.
    End point values
    		 Per protocol analysis
    Number of subjects analysed
    23
    Units: Months
        median (inter-quartile range (Q1-Q3))
    10.87 (8.15 to 23.46)
    No statistical analyses for this end point

    Secondary: Progression free survival at six months

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    End point title
    		 Progression free survival at six months
    End point description
    End point type
    Secondary
    End point timeframe
    Six months from registration
    End point values
    		 Per protocol analysis
    Number of subjects analysed
    23
    Units: Proportion progression-free
        arithmetic mean (confidence interval 95%)
    60.56 (37.83 to 77.2)
    No statistical analyses for this end point

    Secondary: Progression Free Survival at one year

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    End point title
    		 Progression Free Survival at one year
    End point description
    End point type
    Secondary
    End point timeframe
    1 year from registration
    End point values
    		 Per protocol analysis
    Number of subjects analysed
    23
    Units: Proportion
        arithmetic mean (confidence interval 95%)
    23.29 (8.54 to 42.2)
    No statistical analyses for this end point

    Secondary: Overall survival at six months

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    End point title
    		 Overall survival at six months
    End point description
    End point type
    Secondary
    End point timeframe
    six months from registration
    End point values
    		 Per protocol analysis
    Number of subjects analysed
    23
    Units: Proportion
        arithmetic mean (confidence interval 95%)
    82.61 (60.06 to 93.09)
    No statistical analyses for this end point

    Secondary: Overall survival at one year

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    End point title
    		 Overall survival at one year
    End point description
    End point type
    Secondary
    End point timeframe
    One year from registration
    End point values
    		 Per protocol analysis
    Number of subjects analysed
    23
    Units: Proportion
        arithmetic mean (confidence interval 95%)
    43.48 (23.29 to 62.12)
    No statistical analyses for this end point

    Secondary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    The objective response rate (ORR) is defined as the number of patients with complete response or partial response.
    End point type
    Secondary
    End point timeframe
    Up to a year from registration
    End point values
    		 Per protocol analysis
    Number of subjects analysed
    23
    Units: Proportion
        arithmetic mean (confidence interval 95%)
    17.39 (4.95 to 38.78)
    No statistical analyses for this end point

    Secondary: Relationship between baseline variables and clinical response

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    End point title
    		 Relationship between baseline variables and clinical response
    End point description
    The Cox proportional hazard model was used to explore whether baseline platelet levels, baseline monocyte levels and baseline haemoglobin predict time to progression. The univariable hazard ratios for each predictor are presented.
    End point type
    Secondary
    End point timeframe
    Whole trial period
    End point values
    		 Per protocol analysis
    Number of subjects analysed
    23
    Units: Hazard ratio
    arithmetic mean (confidence interval 95%)
        Platelets
    0.998 (0.993 to 1.003)
        Monocytes
    0.6925 (0.0734 to 6.5357)
        Haemoglobin
    1.2168 (0.8971 to 1.6505)
        Hematocrit*10
    1.9029 (0.6279 to 5.7667)
        Mesothelin
    0.9371 (0.8567 to 1.0251)
        Humoral 5T4
    1.007 (0.9754 to 1.0396)
    No statistical analyses for this end point

    Secondary: Relationship between baseline variables and immune response

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    End point title
    		 Relationship between baseline variables and immune response
    End point description
    A logistic regression model was used to explore the effect of haemoglobin, haematocrit soluble mesothelin and baseline 5T4 antibody level on the post treatment 5T4 antibody response.
    End point type
    Secondary
    End point timeframe
    Whole trial period
    End point values
    		 Per protocol analysis
    Number of subjects analysed
    23
    Units: Odds Ratio
    arithmetic mean (confidence interval 95%)
        Platelets
    1.0564 (0.9378 to 1.19)
        Monocytes
    147.61 (0.0111 to 2000000)
        Haemoglobin
    0.3704 (0.0553 to 2.4822)
        Hematocrit*10
    0.0324 (0.0001 to 13.6008)
        Mesothelin
    1.399 (0.3872 to 5.0618)
        Humoral 5T4
    1.0025 (0.8767 to 1.1462)
    No statistical analyses for this end point

    Other pre-specified: Humoral 5T4 overall response

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    End point title
    		 Humoral 5T4 overall response
    End point description
    Contributes to the primary endpoint.
    End point type
    Other pre-specified
    End point timeframe
    The immune response is measured at six follow-up time points: after 2 injections; after 3 injections; after 4 injections; after 5 injections; after 9 injections; 10 weeks after the last injection.
    End point values
    		 Per protocol analysis
    Number of subjects analysed
    23
    Units: subjects
    17
    No statistical analyses for this end point

    Other pre-specified: Cellular 5T4 overall response

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    End point title
    		 Cellular 5T4 overall response
    End point description
    Contributes to the primary endpoint.
    End point type
    Other pre-specified
    End point timeframe
    The immune response is measured at six follow-up time points: after 2 injections; after 3 injections; after 4 injections; after 5 injections; after 9 injections; 10 weeks after the last injection.
    End point values
    		 Per protocol analysis
    Number of subjects analysed
    23
    Units: subjects
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from patient enrolment until the end of follow-up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.02
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 All patients who were registered for the trial.

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 29 (62.07%)
         number of deaths (all causes)
    14
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Phlebitis
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thromboembolic event
         subjects affected / exposed
    5 / 29 (17.24%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Nervous system disorders
    Altered neurology left leg paraesthesia
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischaemia
    Additional description: Ischemia cerebrovascular, Cerebral infarction
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebrovascular accident
    Additional description: Left Cerebrovascular accident
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Numbness in left foot
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
    Additional description: Febrile neutropenia
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
    Additional description: Pleural effusion secondary to mesothelioma (previously Pulmonary Embolism)
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute renal failure
    Additional description: Acute kidney injury
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infections and infestations - Other, chest infection
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 29 (93.10%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    7
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Edema limbs
         subjects affected / exposed
    5 / 29 (17.24%)
         occurrences all number
    7
    Fatigue
         subjects affected / exposed
    19 / 29 (65.52%)
         occurrences all number
    33
    Fever
         subjects affected / exposed
    5 / 29 (17.24%)
         occurrences all number
    8
    Flu like symptoms
         subjects affected / exposed
    7 / 29 (24.14%)
         occurrences all number
    7
    Non-Cardiac Chest pain
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    4
    Rhinorrhoea
         subjects affected / exposed
    5 / 29 (17.24%)
         occurrences all number
    6
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 29 (37.93%)
         occurrences all number
    22
    Dyspnea
         subjects affected / exposed
    15 / 29 (51.72%)
         occurrences all number
    25
    Epistaxis
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    4
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Depression
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    4
    Insomnia
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Investigations
    Creatinine increased
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    4
    Neutrophil count decreased
         subjects affected / exposed
    10 / 29 (34.48%)
         occurrences all number
    14
    Weight loss
         subjects affected / exposed
    9 / 29 (31.03%)
         occurrences all number
    15
    White blood cell decreased
         subjects affected / exposed
    5 / 29 (17.24%)
         occurrences all number
    5
    Cardiac disorders
    Cardiac disorders - Other, unspecified tachycardia
         subjects affected / exposed
    5 / 29 (17.24%)
         occurrences all number
    14
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 29 (24.14%)
         occurrences all number
    8
    Dysgeusia
         subjects affected / exposed
    9 / 29 (31.03%)
         occurrences all number
    17
    Headache
         subjects affected / exposed
    7 / 29 (24.14%)
         occurrences all number
    10
    Peripheral sensory neuropathy
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    9 / 29 (31.03%)
         occurrences all number
    14
    Ear and labyrinth disorders
    Hearing impaired
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Tinnitus
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    4
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Watering eyes
         subjects affected / exposed
    9 / 29 (31.03%)
         occurrences all number
    17
    Gastrointestinal disorders
    Bloating
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    4
    Constipation
         subjects affected / exposed
    12 / 29 (41.38%)
         occurrences all number
    34
    Diarrhea
         subjects affected / exposed
    5 / 29 (17.24%)
         occurrences all number
    9
    Dyspepsia
         subjects affected / exposed
    6 / 29 (20.69%)
         occurrences all number
    8
    Esophagitis
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    3
    Mucositis
    Additional description: Location of mucositis (e.g. oral) not available
         subjects affected / exposed
    14 / 29 (48.28%)
         occurrences all number
    17
    Nausea
         subjects affected / exposed
    12 / 29 (41.38%)
         occurrences all number
    24
    Oral candidiasis
         subjects affected / exposed
    4 / 29 (13.79%)
         occurrences all number
    5
    Vomiting
         subjects affected / exposed
    7 / 29 (24.14%)
         occurrences all number
    11
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    4 / 29 (13.79%)
         occurrences all number
    6
    Renal and urinary disorders
    Urinary frequency (nocturia)
    Additional description: Nocturia
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    3
    Urinary frequency
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 29 (17.24%)
         occurrences all number
    7
    Chest wall pain
         subjects affected / exposed
    10 / 29 (34.48%)
         occurrences all number
    26
    Muscle weakness
    Additional description: Generalized Muscle weakness
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    4
    Musculoskeletal and connective tissue disorder - Other, rotator cuff pain
         subjects affected / exposed
    5 / 29 (17.24%)
         occurrences all number
    6
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    12 / 29 (41.38%)
         occurrences all number
    16
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    11 / 29 (37.93%)
         occurrences all number
    21

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Feb 2012
    The was to notify the MHRA of an amendment to the Investigational Medicinal Product Dossier for Trovax for the SKOPOS trial.
    28 Aug 2012
    This substantial amendment was to support an extension for the shelf life of TroVax drug product and matching placebo, stored at ≤ -15⁰c, from 60 months to 72 months.
    23 Jan 2013
    This substantial amendment was to notify the MHRA of an amendment to the Investigators Brochure for TroVax, to Version 9.0. The PIS was amended to Version 3.0 to include additional information on treatment side effects. In addition, the IMP labels were updated to include the vial number.
    17 Apr 2013
    This amendment was submitted to notify the MHRA of a change to the Protocol (to version 3.0) and the participant information sheet (to version 4). The protocol was updated to allow for phase I research nurses at Velindre Hospital to administer the TroVax injections in addition to the delegated clinicians. The timing of the treatment schedule was also adjusted to allow an extra day for the administration of TroVax and chemotherapy, and an extra week for a CT scan to be completed. The participant information sheet and consent form was also updated to reflect the changes to the timing of the CT scan.
    03 Oct 2013
    This substantial amendment was to support an extension for the shelf life of TroVax drug product and matching placebo.
    01 Apr 2014
    This substantial amendment was to notify the MHRA of an amendment to the Investigators Brochure for TroVax (to Version 10.0) and protocol (to Version 5.0). The protocol was updated to include changes to the blood cell count values as part of the eligibility criteria and to clarify the CT schedule and RECIST assessment. In addition, the amendment notified the MHRA of a recruitment extension until the end of October 2014.
    11 Nov 2014
    This substantial amendment was to support an extension for the shelf life of TroVax drug product and matching placebo.
    23 Sep 2015
    This substantial amendment was to notify the MHRA of an amendment to the Investigators Brochure for TroVax (to Version 11.0) and to support an extension for the shelf life of TroVax drug product and matching placebo.

    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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