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    Clinical Trial Results:
    An Extension Protocol to Evaluate the Efficacy and Safety of Extended Use Treatment with OncoVEX^GM-CSF for Eligible Melanoma Patients Participating in Study 005/05

    Summary
    EudraCT number
    		 2010-021070-11
    Trial protocol
    		 GB  
    Global end of trial date
    08 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Apr 2016
    First version publication date
    30 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    005/05-E
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01368276
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Amgen study ID: 20110279
    Sponsors
    Sponsor organisation name
    Amgen, Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States, 91320
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.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
    08 Aug 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to learn about the safety and the risks of using talimogene laherparepvec in patients who already received treatment with talimogene laherparepvec in study 005/05 (2008-006140-20), and to see if extended treatment with talimogene laherparepvec can destroy melanoma tumors.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines. Written informed consent, properly witnessed and executed, was obtained from each subject before study entry. The protocol, informed consent, and other appropriate study documentation were approved by the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) of each study center before the study began.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Oct 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    South Africa: 2
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 27
    Worldwide total number of subjects
    31
    EEA total number of subjects
    2
    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)
    16
    From 65 to 84 years
    13
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 This extension was available to patients who participated in study 005/05 (2008-006140-20), received the maximum allowable number of treatments or developed new lesion(s) within ≤ 12 months from the end of treatment visit after previous resolution of all disease while on study 005/05, and warranted further treatment per the investigator.

    Pre-assignment
    Screening details
    		 Participants received the same treatment as randomized under the 005/05 study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GM-CSF
    Arm description
    		 Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    125 µg/m² subcutaneous injection

    Arm title
    		 Talimogene Laherparepvec
    Arm description
    		 Talimogene laherparepvec was administered at a concentration of 10⁸ plaque forming units (PFU)/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Talimogene Laherparepvec
    Investigational medicinal product code
    Other name
    OncoVEX^GM-CSF, IMLYGIC™
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratumoral use
    Dosage and administration details
    Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection

    Number of subjects in period 1
    		GM-CSF Talimogene Laherparepvec
    Started
    3
    28
    Completed
    2
    18
    Not completed
    1
    10
         Death
    1
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GM-CSF
    Reporting group description
    		 Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.

    Reporting group title
    Talimogene Laherparepvec
    Reporting group description
    		 Talimogene laherparepvec was administered at a concentration of 10⁸ plaque forming units (PFU)/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.

    Reporting group values
    		 GM-CSF Talimogene Laherparepvec Total
    Number of subjects
    		 3 28 31
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 15 16
        From 65-84 years
    		 2 11 13
        85 years and over
    		 0 2 2
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.7 ( 25 ) 64.2 ( 13.2 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 2 14 16
        Male
    		 1 14 15
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 3 28 31
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
    Units: Subjects
        Grade 0
    		 3 20 23
        Grade 1
    		 0 8 8
    Disease Stage
    Stage IIIB: Ulcerated lesion and 1 lymph node or 2-3 nodes with micrometastasis, or any-depth lesion with no ulceration, and 1 lymph node or 2-3 nodes with macrometastasis; Stage IIIC: Ulcerated lesion and 1 lymph node with macrometastasis; 2-3 nodes with macrometastasis or ≥ 4 metastatic lymph nodes, matted lymph nodes, or in-transit met(s)/satellite(s); Stage IV: M1a: Spread to skin, subcutaneous tissue, or lymph nodes; normal lactate dehydrogenase (LDH) level; M1b: Spread to lungs; normal LDH; M1c: Spread to all other visceral organs, normal LDH or any distant disease with elevated LDH.
    Units: Subjects
        Stage IIIB
    		 0 1 1
        Stage IIIC
    		 0 6 6
        Stage IV M1a
    		 1 9 10
        Stage IV M1b
    		 1 8 9
        Stage IV M1c
    		 1 4 5

    End points

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    End points reporting groups
    Reporting group title
    GM-CSF
    Reporting group description
    		 Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.

    Reporting group title
    Talimogene Laherparepvec
    Reporting group description
    		 Talimogene laherparepvec was administered at a concentration of 10⁸ plaque forming units (PFU)/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.

    Primary: Number of Participants with Treatment-emergent Adverse Events (AEs)

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    End point title
    		 Number of Participants with Treatment-emergent Adverse Events (AEs) [1]
    End point description
    AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 based on the following guideline: Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE. Treatment-related AE refers to AEs that have possible or probable relation to study treatment as determined by the investigator. A serious AE is one that meets one or more of the following criteria/outcomes: • Results in death. • Is life-threatening. • Requires inpatient hospitalization or prolongation of existing hospitalization. • Results in persistent or significant disability/incapacity. • Is a congenital anomaly/birth defect. • Is an important medical event.
    End point type
    Primary
    End point timeframe
    From first administration of study drug in the extension period until 30 days after last dose. Median duration of treatment was 50 weeks in the GM-CSF group and 36 weeks in the talimogene laherparepvec group.
    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: Statistical analyses were not performed.
    End point values
    		 GM-CSF Talimogene Laherparepvec
    Number of subjects analysed
    3
    28
    Units: participants
    number (not applicable)
        All adverse events
    3
    26
        Worst grade of 3
    0
    5
        Worst grade of 4
    0
    1
        Worst grade of 5
    0
    2
        Serious adverse events
    0
    9
        Treatment-related adverse events
    3
    20
        Treatment-related serious adverse events
    0
    1
        Leading to discontinuation of study treatment
    0
    4
        Leading to study treatment delay
    0
    4
        Fatal adverse events on-study
    0
    2
    No statistical analyses for this end point

    Secondary: Objective Response Rate

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    End point title
    		 Objective Response Rate
    End point description
    Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the investigator. Best overall response for a patient is the best overall response observed across all time points and is cumulative (ie, includes responses during the parent study 005/05 and during Study 005/05-E). Disease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria. CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline. For 100% response, the asymptotic 95% CI was not estimated since the mathematical formula is not considered appropriate in such extreme cases; this is represented by "100" in the table below.
    End point type
    Secondary
    End point timeframe
    From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.
    End point values
    		 GM-CSF Talimogene Laherparepvec
    Number of subjects analysed
    3
    28
    Units: percentage of participants
        number (confidence interval 95%)
    100 (100 to 100)
    57.1 (38.8 to 75.5)
    Statistical analysis title
    		 Objective Response Rate Analysis
    Comparison groups
    GM-CSF v Talimogene Laherparepvec
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.2645
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [2] - Descriptive

    Secondary: Durable Response Rate

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    End point title
    		 Durable Response Rate
    End point description
    Durable response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) assessed by the investigator, initiating at any time while receiving talimogene laherparepvec or GM-CSF therapy on the 005/05 or the 005/05-E study and maintained continuously for at least 6 months from response initiation. This reflects all new sites of disease as well as disease sites identified at baseline. Disease assessments were performed at the beginning of each treatment cycle in accordance with modified World Health Organization criteria. CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline.
    End point type
    Secondary
    End point timeframe
    From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.
    End point values
    		 GM-CSF Talimogene Laherparepvec
    Number of subjects analysed
    3
    28
    Units: percentage of participants
        number (confidence interval 95%)
    33.3 (0 to 86.7)
    32.1 (14.8 to 49.4)
    Statistical analysis title
    		 Durable Response Rate Analysis
    Comparison groups
    GM-CSF v Talimogene Laherparepvec
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 1
    Method
    		 Fisher exact
    Parameter type
    		 Treatment Difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -57.3
         upper limit
    		 54.9
    Notes
    [3] - Descriptive

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first administration of study drug in the extension period until 30 days after last dose. Median duration of treatment was 50 weeks in the GM-CSF group and 36 weeks in the talimogene laherparepvec group.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Talimogene Laherparepvec
    Reporting group description
    		 Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.

    Reporting group title
    GM-CSF
    Reporting group description
    		 GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.

    Serious adverse events
    		 Talimogene Laherparepvec GM-CSF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 28 (32.14%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma of liver
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Restrictive cardiomyopathy
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Talimogene Laherparepvec GM-CSF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 28 (75.00%)
    3 / 3 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 3 (33.33%)
         occurrences all number
    1
    1
    Tumour pain
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
         occurrences all number
    4
    0
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
         occurrences all number
    4
    0
    Dizziness
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 28 (10.71%)
    2 / 3 (66.67%)
         occurrences all number
    4
    9
    Chills
         subjects affected / exposed
    5 / 28 (17.86%)
    1 / 3 (33.33%)
         occurrences all number
    13
    7
    Injection site mass
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Injection site pain
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    Oedema peripheral
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 3 (33.33%)
         occurrences all number
    3
    1
    Influenza like illness
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 3 (33.33%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    5 / 28 (17.86%)
    1 / 3 (33.33%)
         occurrences all number
    13
    7
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
         occurrences all number
    5
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 28 (14.29%)
    1 / 3 (33.33%)
         occurrences all number
    5
    2
    Abdominal discomfort
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
         occurrences all number
    4
    0
    Nausea
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 3 (33.33%)
         occurrences all number
    2
    1
    Vomiting
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 3 (33.33%)
         occurrences all number
    3
    1
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 3 (33.33%)
         occurrences all number
    1
    4
    Cough
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 3 (66.67%)
         occurrences all number
    1
    2
    Hypopnoea
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 3 (33.33%)
         occurrences all number
    5
    3
    Skin and subcutaneous tissue disorders
    Ecchymosis
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 3 (33.33%)
         occurrences all number
    1
    1
    Blood blister
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    4
    Pruritus
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 3 (33.33%)
         occurrences all number
    2
    4
    Skin irritation
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
         occurrences all number
    3
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 3 (33.33%)
         occurrences all number
    1
    5
    Night sweats
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Vitiligo
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 3 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 28 (14.29%)
    0 / 3 (0.00%)
         occurrences all number
    4
    0
    Myalgia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 3 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 3 (33.33%)
         occurrences all number
    2
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 3 (33.33%)
         occurrences all number
    3
    1
    Oral herpes
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Nov 2011
    - Allowed the inclusion of subjects randomized to GM-CSF in the parent study in this extension study. The subjects remained on GM-CSF and information on GM-CSF administration was included in the protocol. - Inclusion criteria 1b revised to read “New lesion(s) appearing after 12 months from randomization after previous resolution of all disease while on study 005/05” - Verbiage added stating the subject will receive study drug randomized under the 005/05 study, crossover is not permitted. - Verbiage added stating that if a subject demonstrates central nervous system (CNS) progressive disease, they may be allowed to remain on study provided CNS lesions can be treated with radiotherapy or surgery.
    29 Oct 2012
    - Continued treatment of ongoing subjects who met the protocol-specified tumor response criteria of partial response after being on study treatment for 12 months and are still benefiting from study treatment - Revised the eligibility criteria to restrict enrollment to subjects with new injectable lesions that appeared within ≤ 12 months from the End of Treatment visit on the Study 005/05. - Revised the eligibility criteria to add a requirement that subjects must not have received anti-tumor therapies for melanoma after end of treatment on Study 05/05 and prior to enrollment on Study 005/05-E with the exception of radiation for palliation or surgical resection of melanoma tumor. - Revised the response criteria to align with the response criteria in the protocol amendment 4 of the Study 005/05. - Deleted the Data Monitoring Committee (DMC) section from the protocol because the procedures in the DMC Charter of the Study 005/05 do not include review of safety data from the extension study.

    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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