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    Clinical Trial Results:
    A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients with Resected Adenocarcinoma of the Pancreas

    Summary
    EudraCT number
    		 2012-002400-40
    Trial protocol
    		 NO   GB   ES  
    Global end of trial date
    10 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 May 2020
    First version publication date
    22 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CT TG01-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02261714
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Targovax ASA
    Sponsor organisation address
    Lilleakerveien 2C, 0283 Oslo, Norway,
    Public contact
    Chief Medical Officer, Targovax ASA, +47 213 98 810, contact@targovax.com
    Scientific contact
    Chief Medical Officer, Targovax ASA, +47 213 98 810, contact@targovax.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
    10 May 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of Phase I of this study was to assess the safety and immune response of co-administration of TG01 with granulocyte macrophage colony stimulating factor (GM-CSF) vaccination when administered concomitantly with adjuvant chemotherapy after primary resection of adenocarcinoma of the pancreas. The objective of Phase II of the study was to further assess the safety, and immune response and efficacy of the TG01/GM-CSF vaccination and adjuvant chemotherapy after primary resection of adenocarcinoma of the pancreas.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki (July 1999), in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (Committee for Proprietary Medicinal Products/ICH/135/95; July 1996), and all applicable regulatory requirements in the countries of conduct.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Jan 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 6 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Norway: 11
    Country: Number of subjects enrolled
    United Kingdom: 21
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    17
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants had confirmed diagnosis of Stage I or II adenocarcinoma of the pancreas, successful surgical resection (R0 or R1), expected to receive gemcitabine as adjuvant chemotherapy ≥12 weeks of surgery, acceptable laboratory test results, Eastern Cooperative Oncology Group performance status of 0 or 1, and a life expectancy of ≥6 months.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Main Group
    Arm description
    		 GM-CSF 0.03 mg & TG01 0.70 mg were given on Days 1 (1 to 12 weeks after surgery), 3, 5, 8, 15 & 22, then every 2 weeks until the end of chemotherapy. If no chemotherapy was started, participants received TG01/GM-CSF on Days 1, 3, 5, 8, 15, 22, 36, 50, & 64, then every 4 weeks until Week 52. All participants could then receive TG01/GM-CSF every 4 weeks until Week 52, then every 12 weeks for up to 2 years or until withdrawal of consent or toxicity. When applicable, chemotherapy started at least 3 weeks after initiation of TG01/GM-CSF on Day 22, 36 or 50 of the initial treatment period. Gemcitabine 1000 mg/m^2 was administered intravenously (iv) over 30 minutes on Days 1, 8 & 15 of a 4-week cycle for 6 cycles. Gemcitabine could be substituted with 5-fluorouracil (5-FU)/leucovorin. Leucovorin was given prior to 5-FU as 60mg/m^2 or 100 mg iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles. 5-FU was given as 500mg/m^2 iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TG01
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    TG01 is a sterile lyophilisate consisting of a mixture of 7 peptides. The finished product is a white powder for injection, consisting only of the active substances containing 2.1 mg of peptides (individual peptides comprising 0.3 mg each). The 0.70 mg dose of TG01 was prepared by reconstituting the lyophilisate with sterile water (0.3 mL) for intrdermal injection (0.10 mL injection of a TG01 solution at 7 mg/mL) into the back of the upper arm. The solution was to be used within 6 hours after reconstitution.

    Investigational medicinal product name
    GM-CSF
    Investigational medicinal product code
    Other name
    Granulocyte macrophage colony stimulating factor
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    GM-CSF was provided as a lyophilised powder containing 0.1 mg of active substance for reconstitution in sterile water (0.33 mL) for intradermal injection (0.10 mL injection of a GM-CSF solution at 0.3 mg/mL) into the back of the upper arm. GM-CSF was to be administered 10 to 15 minutes before TG01. The solution was to be used within 6 hours after reconstitution.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine was provided as a lyophilised powder (vials of 200 mg and 1 g) for reconstitution in saline to be given via iv infusion at a dose of 1000 mg/m^2 over 30 minutes.

    Investigational medicinal product name
    5-FU
    Investigational medicinal product code
    Other name
    5-fluorouracil
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    5-FU was provided as a solution for iv injection (vials of 500 mg in 10 mL) administered at a dose of 500 mg/m^2.

    Investigational medicinal product name
    Leucovorin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Leucovorin was provided as a solution for iv injection (10 mg/mL) administered at a dose of 60 mg/m^2 or 100 mg.

    Arm title
    		 Concomitant Group
    Arm description
    		 GM-CSF 0.03 mg & TG01 0.70 mg was given on Days 1 (9 to 12 weeks after surgery), 3, 5, 8 & 15, then every 2 weeks until the end of chemotherapy. If no chemotherapy was started, participants received TG01/GM-CSF on Days 1, 3, 5, 8, 15, 22, 36, 50, & 64, then every 4 weeks until Week 52. All participants could then receive TG01/GM-CSF every 4 weeks until Week 52, then every 12 weeks for up to 2 years or until withdrawal of consent or toxicity. Chemotherapy could start at the same time as TG01/GM-CSF treatment between 9 and 12 weeks after surgery but no later than 12 weeks from the date of surgery. Gemcitabine 1000 mg/m^2 was administered iv over 30 minutes on Days 1, 8 & 15 of a 4-week cycle for 6 cycles. Gemcitabine could be substituted with 5-FU/leucovorin. Leucovorin was given prior to 5-FU as 60 mg/m^2 or 100 mg iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles. 5-FU was given as 500 mg/m^2 iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TG01
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    TG01 is a sterile lyophilisate consisting of a mixture of 7 peptides. The finished product is a white powder for injection, consisting only of the active substances containing 2.1 mg of peptides (individual peptides comprising 0.3 mg each). The 0.70 mg dose of TG01 was prepared by reconstituting the lyophilisate with sterile water (0.3 mL) for intrdermal injection (0.10 mL injection of a TG01 solution at 7 mg/mL) into the back of the upper arm. The solution was to be used within 6 hours after reconstitution.

    Investigational medicinal product name
    GM-CSF
    Investigational medicinal product code
    Other name
    Granulocyte macrophage colony stimulating factor
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    GM-CSF was provided as a lyophilised powder containing 0.1 mg of active substance for reconstitution in sterile water (0.33 mL) for intradermal injection (0.10 mL injection of a GM-CSF solution at 0.3 mg/mL) into the back of the upper arm. GM-CSF was to be administered 10 to 15 minutes before TG01. The solution was to be used within 6 hours after reconstitution.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine was provided as a lyophilised powder (vials of 200 mg and 1 g) for reconstitution in saline to be given via iv infusion at a dose of 1000 mg/m^2 over 30 minutes.

    Investigational medicinal product name
    5-FU
    Investigational medicinal product code
    Other name
    5-fluorouracil
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    5-FU was provided as a solution for iv injection (vials of 500 mg in 10 mL) administered at a dose of 500 mg/m^2.

    Investigational medicinal product name
    Leucovorin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Leucovorin was provided as a solution for iv injection (10 mg/mL) administered at a dose of 60 mg/m^2 or 100 mg.

    Arm title
    		 Modified Vaccination Group
    Arm description
    		 GM-CSF 0.03 mg & TG01 0.70 mg were given on Days 1, 8, 15, 22 & 36, then restarted 4 weeks after the end of chemotherapy. If chemotherapy started after Week 10 or not at all, participants received TG01/GM-CSF every 4 weeks from Week 10 until chemotherapy started or until Week 52. All participants could then receive TG01/GM-CSF every 4 weeks (plus once at Week 5 post-chemotherapy) until Week 52, then every 12 weeks for up to 2 years or until withdrawal of consent or toxicity. Chemotherapy preferably started at least 3 weeks after initiation of TG01/GM-CSF on Day 22, 36 or 50 of the initial treatment period. Gemcitabine 1000 mg/m^2 was administered iv over 30 minutes on Days 1, 8 & 15 of a 4-week cycle for 6 cycles. Gemcitabine could be substituted with 5-FU/leucovorin. Leucovorin was given prior to 5-FU as 60 mg/m^2 or 100 mg iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles. 5-FU was given as 500 mg/m^2 iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TG01
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    TG01 is a sterile lyophilisate consisting of a mixture of 7 peptides. The finished product is a white powder for injection, consisting only of the active substances containing 2.1 mg of peptides (individual peptides comprising 0.3 mg each). The 0.70 mg dose of TG01 was prepared by reconstituting the lyophilisate with sterile water (0.3 mL) for intrdermal injection (0.10 mL injection of a TG01 solution at 7 mg/mL) into the back of the upper arm. The solution was to be used within 6 hours after reconstitution.

    Investigational medicinal product name
    GM-CSF
    Investigational medicinal product code
    Other name
    Granulocyte macrophage colony stimulating factor
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    GM-CSF was provided as a lyophilised powder containing 0.1 mg of active substance for reconstitution in sterile water (0.33 mL) for intradermal injection (0.10 mL injection of a GM-CSF solution at 0.3 mg/mL) into the back of the upper arm. GM-CSF was to be administered 15 to 20 minutes before TG01. The solution was to be used within 6 hours after reconstitution.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine was provided as a lyophilised powder (vials of 200 mg and 1 g) for reconstitution in saline to be given via iv infusion at a dose of 1000 mg/m^2 over 30 minutes.

    Investigational medicinal product name
    5-FU
    Investigational medicinal product code
    Other name
    5-fluorouracil
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    5-FU was provided as a solution for iv injection (vials of 500 mg in 10 mL) administered at a dose of 500 mg/m^2.

    Investigational medicinal product name
    Leucovorin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Leucovorin was provided as a solution for iv injection (10 mg/mL) administered at a dose of 60 mg/m^2 or 100 mg.

    Number of subjects in period 1
    		Main Group Concomitant Group Modified Vaccination Group
    Started
    15
    4
    13
    Completed
    0
    1
    3
    Not completed
    15
    3
    10
         Consent withdrawn by subject
    3
    -
    1
         Physician decision
    2
    -
    -
         Disease recurrence requiring alternative treatment
    5
    2
    7
         Death
    2
    -
    -
         Adverse event
    3
    1
    1
         Unspecified
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 32 32
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.1 ± 8.90 -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 21 21

    End points

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    End points reporting groups
    Reporting group title
    Main Group
    Reporting group description
    		 GM-CSF 0.03 mg & TG01 0.70 mg were given on Days 1 (1 to 12 weeks after surgery), 3, 5, 8, 15 & 22, then every 2 weeks until the end of chemotherapy. If no chemotherapy was started, participants received TG01/GM-CSF on Days 1, 3, 5, 8, 15, 22, 36, 50, & 64, then every 4 weeks until Week 52. All participants could then receive TG01/GM-CSF every 4 weeks until Week 52, then every 12 weeks for up to 2 years or until withdrawal of consent or toxicity. When applicable, chemotherapy started at least 3 weeks after initiation of TG01/GM-CSF on Day 22, 36 or 50 of the initial treatment period. Gemcitabine 1000 mg/m^2 was administered intravenously (iv) over 30 minutes on Days 1, 8 & 15 of a 4-week cycle for 6 cycles. Gemcitabine could be substituted with 5-fluorouracil (5-FU)/leucovorin. Leucovorin was given prior to 5-FU as 60mg/m^2 or 100 mg iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles. 5-FU was given as 500mg/m^2 iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles.

    Reporting group title
    Concomitant Group
    Reporting group description
    		 GM-CSF 0.03 mg & TG01 0.70 mg was given on Days 1 (9 to 12 weeks after surgery), 3, 5, 8 & 15, then every 2 weeks until the end of chemotherapy. If no chemotherapy was started, participants received TG01/GM-CSF on Days 1, 3, 5, 8, 15, 22, 36, 50, & 64, then every 4 weeks until Week 52. All participants could then receive TG01/GM-CSF every 4 weeks until Week 52, then every 12 weeks for up to 2 years or until withdrawal of consent or toxicity. Chemotherapy could start at the same time as TG01/GM-CSF treatment between 9 and 12 weeks after surgery but no later than 12 weeks from the date of surgery. Gemcitabine 1000 mg/m^2 was administered iv over 30 minutes on Days 1, 8 & 15 of a 4-week cycle for 6 cycles. Gemcitabine could be substituted with 5-FU/leucovorin. Leucovorin was given prior to 5-FU as 60 mg/m^2 or 100 mg iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles. 5-FU was given as 500 mg/m^2 iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles.

    Reporting group title
    Modified Vaccination Group
    Reporting group description
    		 GM-CSF 0.03 mg & TG01 0.70 mg were given on Days 1, 8, 15, 22 & 36, then restarted 4 weeks after the end of chemotherapy. If chemotherapy started after Week 10 or not at all, participants received TG01/GM-CSF every 4 weeks from Week 10 until chemotherapy started or until Week 52. All participants could then receive TG01/GM-CSF every 4 weeks (plus once at Week 5 post-chemotherapy) until Week 52, then every 12 weeks for up to 2 years or until withdrawal of consent or toxicity. Chemotherapy preferably started at least 3 weeks after initiation of TG01/GM-CSF on Day 22, 36 or 50 of the initial treatment period. Gemcitabine 1000 mg/m^2 was administered iv over 30 minutes on Days 1, 8 & 15 of a 4-week cycle for 6 cycles. Gemcitabine could be substituted with 5-FU/leucovorin. Leucovorin was given prior to 5-FU as 60 mg/m^2 or 100 mg iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles. 5-FU was given as 500 mg/m^2 iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles.

    Subject analysis set title
    Main + Concomitant Group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    GM-CSF 0.03 mg & TG01 0.70 mg were given on Days 1 (1 to 12 weeks after surgery), 3, 5, 8, 15 & 22 (main group only), then every 2 weeks until the end of chemotherapy. If no chemotherapy was started, participants received TG01/GM-CSF on Days 1, 3, 5, 8, 15, 22, 36, 50, & 64, then every 4 weeks until Week 52. All participants could then receive TG01/GM-CSF every 4 weeks until Week 52, then every 12 weeks for up to 2 years or until withdrawal of consent or toxicity. When applicable, chemotherapy started at least 3 weeks after initiation of TG01/GM-CSF (main group) or at the same time (concomitant group). Gemcitabine 1000 mg/m^2 was administered iv over 30 minutes on Days 1, 8 & 15 of a 4-week cycle for 6 cycles. Gemcitabine could be substituted with 5-FU/leucovorin. Leucovorin was given prior to 5-FU as 60 mg/m^2 or 100 mg iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles. 5-FU was given as 500 mg/m^2 iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles.

    Primary: Participants with a Positive Immune Response Assessed by Delayed-type Hypersensitivity (DTH) and/or T-cell Tests

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    End point title
    		 Participants with a Positive Immune Response Assessed by Delayed-type Hypersensitivity (DTH) and/or T-cell Tests [1] [2]
    End point description
    An immune responder was defined as a participant who had a positive DTH and/or a positive T-cell test from blood samples collected at least once during the entire study period. The DTH skin reaction assessment was performed 48 hours (±4 hours) after each administration. The DTH test was considered positive if the area of the skin reaction had an average diameter of ≥5 mm at the 48 hours (±4 hours) assessment. Blood samples were analysed for TG01-specific T-cell responses by proliferation assays. Specific T-cell responses were considered positive if the stimulation index (SI) was ≥2. The SI was derived as mean (T cells + peripheral blood mononuclear cell [PBMC] + TG01)/ mean (T cells + PBMC [negative control]).
    End point type
    Primary
    End point timeframe
    Immune response during the entire study period.
    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: No formal statistical analyses were planned for the primary endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As participants in the Main Group and Concomitant Group followed similar treatment regimens, the data from these participants was combined and reported in the Main + Concomitant Group.
    End point values
    		 Modified Vaccination Group Main + Concomitant Group
    Number of subjects analysed
    13
    19
    Units: Number of participants
    12
    18
    No statistical analyses for this end point

    Secondary: Disease Free Survival (DFS) from Surgery Until First Documented Disease Recurrence or Death

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    End point title
    		 Disease Free Survival (DFS) from Surgery Until First Documented Disease Recurrence or Death [3]
    End point description
    DFS at 2 years was defined as the number of months from surgery until first documented disease recurrence or death from any cause. If disease recurrence or death was not recorded for a participant before the end of the study, DFS was censored at the date that they were last known to be recurrence free. If a participant had no post-surgery disease assessment, then DFS was censored at the date of surgery. 9999 = not calculable
    End point type
    Secondary
    End point timeframe
    2 years
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As participants in the Main Group and Concomitant Group followed similar treatment regimens, the data from these participants was combined and reported in the Main + Concomitant Group.
    End point values
    		 Modified Vaccination Group Main + Concomitant Group
    Number of subjects analysed
    13
    19
    Units: Months
        median (confidence interval 95%)
    19.5 (9.7 to 9999)
    13.9 (5.4 to 21.0)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS) from Surgery Until Death

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    End point title
    		 Overall Survival (OS) from Surgery Until Death [4]
    End point description
    OS was defined as the number of months from surgery to death from any cause. If an event (death) was not recorded for a participant before the end of the follow-up, OS was censored at the date that they were last known to be alive.
    End point type
    Secondary
    End point timeframe
    End of follow-up
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As participants in the Main Group and Concomitant Group followed similar treatment regimens, the data from these participants was combined and reported in the Main + Concomitant Group.
    End point values
    		 Modified Vaccination Group Main + Concomitant Group
    Number of subjects analysed
    13
    19
    Units: Months
        median (confidence interval 95%)
    34.3 (19.2 to 42.5)
    33.1 (16.8 to 45.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were to be reported throughout the study and during the 28-day follow-up period after the last administration of study treatment.
    Adverse event reporting additional description
    AEs considered related to treatment could have been assessed by the Investigator as causally related to TG01, TG01 only, GM-CSF, GM-CSF only, TG01 and/or GM-CSF, TG01 and GM-CSF only, or chemotherapy only.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Main Group
    Reporting group description
    		 GM-CSF 0.03 mg & TG01 0.70 mg were given on Days 1 (1 to 12 weeks after surgery), 3, 5, 8, 15 & 22, then every 2 weeks until the end of chemotherapy. If no chemotherapy was started, participants received TG01/GM-CSF on Days 1, 3, 5, 8, 15, 22, 36, 50, & 64, then every 4 weeks until Week 52. All participants could then receive TG01/GM-CSF every 4 weeks until Week 52, then every 12 weeks for up to 2 years or until withdrawal of consent or toxicity. When applicable, chemotherapy started at least 3 weeks after initiation of TG01/GM-CSF on Day 22, 36 or 50 of the initial treatment period. Gemcitabine 1000 mg/m^2 was administered iv over 30 minutes on Days 1, 8 & 15 of a 4-week cycle for 6 cycles. Gemcitabine could be substituted with 5-FU/leucovorin. Leucovorin was given prior to 5-FU as 60 mg/m^2 or 100 mg iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles. 5-FU was given as 500 mg/m^2 iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles.

    Reporting group title
    Concomitant Group
    Reporting group description
    		 GM-CSF 0.03 mg & TG01 0.70 mg was given on Days 1 (9 to 12 weeks after surgery), 3, 5, 8 & 15, then every 2 weeks until the end of chemotherapy. If no chemotherapy was started, participants received TG01/GM-CSF on Days 1, 3, 5, 8, 15, 22, 36, 50, & 64, then every 4 weeks until Week 52. All participants could then receive TG01/GM-CSF every 4 weeks until Week 52, then every 12 weeks for up to 2 years or until withdrawal of consent or toxicity. Chemotherapy could start at the same time as TG01/GM-CSF treatment between 9 and 12 weeks after surgery but no later than 12 weeks from the date of surgery. Gemcitabine 1000 mg/m^2 was administered iv over 30 minutes on Days 1, 8 & 15 of a 4-week cycle for 6 cycles. Gemcitabine could be substituted with 5-FU/leucovorin. Leucovorin was given prior to 5-FU as 60 mg/m^2 or 100 mg iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles. 5-FU was given as 500 mg/m^2 iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles.

    Reporting group title
    Modified Vaccination Group
    Reporting group description
    		 GM-CSF 0.03 mg & TG01 0.70 mg were given on Days 1, 8, 15, 22 & 36, then restarted 4 weeks after the end of chemotherapy. If chemotherapy started after Week 10 or not at all, participants received TG01/GM-CSF every 4 weeks from Week 10 until chemotherapy started or until Week 52. All participants could then receive TG01/GM-CSF every 4 weeks (plus once at Week 5 post-chemotherapy) until Week 52, then every 12 weeks for up to 2 years or until withdrawal of consent or toxicity. Chemotherapy preferably started at least 3 weeks after initiation of TG01/GM-CSF on Day 22, 36 or 50 of the initial treatment period. Gemcitabine 1000 mg/m^2 was administered iv over 30 minutes on Days 1, 8 & 15 of a 4-week cycle for 6 cycles. Gemcitabine could be substituted with 5-FU/leucovorin. Leucovorin was given prior to 5-FU as 60 mg/m^2 or 100 mg iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles. 5-FU was given as 500 mg/m^2 iv on Days 1 & 2 every 2 weeks of a 4-week cycle for 6 cycles.

    Serious adverse events
    		 Main Group Concomitant Group Modified Vaccination Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 15 (33.33%)
    2 / 4 (50.00%)
    4 / 13 (30.77%)
         number of deaths (all causes)
    12
    2
    4
         number of deaths resulting from adverse events
    1
    0
    0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Lung infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         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
    		 Main Group Concomitant Group Modified Vaccination Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 15 (100.00%)
    4 / 4 (100.00%)
    13 / 13 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Skin papilloma
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 4 (25.00%)
    4 / 13 (30.77%)
         occurrences all number
    5
    1
    4
    Phlebitis
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    Peripheral coldness
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Thrombophlebitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombosis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Flushing
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    Hypotension
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    5
    Surgical and medical procedures
    Skin neoplasm excision
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 15 (53.33%)
    4 / 4 (100.00%)
    10 / 13 (76.92%)
         occurrences all number
    11
    6
    16
    Influenza like illness
         subjects affected / exposed
    4 / 15 (26.67%)
    3 / 4 (75.00%)
    2 / 13 (15.38%)
         occurrences all number
    7
    7
    4
    Pyrexia
         subjects affected / exposed
    5 / 15 (33.33%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    8
    1
    0
    Injection site reaction
         subjects affected / exposed
    4 / 15 (26.67%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    7
    1
    0
    Chills
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 4 (25.00%)
    4 / 13 (30.77%)
         occurrences all number
    1
    1
    5
    Injection site pruritus
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 4 (25.00%)
    2 / 13 (15.38%)
         occurrences all number
    2
    1
    9
    Oedema peripheral
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 4 (25.00%)
    2 / 13 (15.38%)
         occurrences all number
    2
    1
    3
    Injection site erythema
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 4 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    4
    0
    3
    Mucosal inflammation
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    0
    Feeling hot
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    2
    Chest discomfort
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Chest pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site swelling
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    Pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    0
    Vaccination site pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Vaccination site reaction
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site bruising
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Injection site urticaria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    Vaccination site pruritus
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 4 (25.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    1
    2
    Cellulitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    2
    Gastroenteritis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    2
    Biliary sepsis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    0
    Anaphylactic reaction
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    Allergy to vaccine
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    Anaphylactic shock
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Genital rash
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Erectile dysfunction
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 4 (25.00%)
    2 / 13 (15.38%)
         occurrences all number
    2
    1
    4
    Dyspnoea exertional
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    0
    0
    3
    Cough
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    1
    Pulmonary embolism
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    2
    Haemoptysis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Pleural effusion
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Orthopnoea
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 15 (26.67%)
    1 / 4 (25.00%)
    6 / 13 (46.15%)
         occurrences all number
    4
    1
    6
    Anxiety
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 4 (25.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    1
    Depressed mood
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Depression
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Panic attack
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    3 / 15 (20.00%)
    2 / 4 (50.00%)
    2 / 13 (15.38%)
         occurrences all number
    4
    4
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    1
    Weight decreased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Platelet count decreased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Blood cholesterol increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Blood glucose fluctuation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Platelet count increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Vitamin D decreased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal wound dehiscence
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Alcohol poisoning
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Femoral neck fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Incisional hernia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Inflammation of wound
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Limb injury
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 15 (13.33%)
    3 / 4 (75.00%)
    3 / 13 (23.08%)
         occurrences all number
    4
    3
    5
    Dysgeusia
         subjects affected / exposed
    3 / 15 (20.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    3
    0
    1
    Dizziness
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    2
    0
    3
    Paraesthesia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    3
    Hyperaesthesia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    0
    Sciatica
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    0
    Cognitive disorder
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Coordination abnormal
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Lethargy
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Neuralgia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Presyncope
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Transient ischaemic attack
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    5 / 15 (33.33%)
    2 / 4 (50.00%)
    7 / 13 (53.85%)
         occurrences all number
    7
    2
    13
    Anaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    1
    2
    Thrombocytopenia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    2
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    1
    Eye pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Foreign body sensation in eyes
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Lacrimation increased
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Diplopia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Eye haemorrhage
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    7 / 15 (46.67%)
    2 / 4 (50.00%)
    7 / 13 (53.85%)
         occurrences all number
    10
    2
    10
    Nausea
         subjects affected / exposed
    8 / 15 (53.33%)
    1 / 4 (25.00%)
    7 / 13 (53.85%)
         occurrences all number
    32
    1
    10
    Diarrhoea
         subjects affected / exposed
    5 / 15 (33.33%)
    2 / 4 (50.00%)
    5 / 13 (38.46%)
         occurrences all number
    5
    2
    6
    Vomiting
         subjects affected / exposed
    4 / 15 (26.67%)
    1 / 4 (25.00%)
    6 / 13 (46.15%)
         occurrences all number
    13
    1
    7
    Abdominal pain upper
         subjects affected / exposed
    2 / 15 (13.33%)
    2 / 4 (50.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    2
    1
    Constipation
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 4 (50.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    2
    0
    Mouth ulceration
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    1
    Flatulence
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    1
    Abdominal distension
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    2
    Abdominal pain lower
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    2
    Abdominal hernia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Glossodynia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Steatorrhoea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Faeces pale
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Oral pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Portal vein thrombosis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 4 (25.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    1
    Dry skin
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 4 (25.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    1
    Pruritus
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    3
    0
    1
    Rash
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 4 (25.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    2
    Night sweats
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    0
    0
    3
    Diabetic foot
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Blister
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Cold sweat
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Scar pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Pollakiuria
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Renal ischaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    2
    0
    3
    Joint swelling
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    1
    0
    2
    Arthralgia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Back pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    2
    Pain in extremity
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    3
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    2
    Limb mass
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Neck pain
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Arthritis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Bone pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Flank pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Groin pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 4 (25.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    1
    Pneumonia
         subjects affected / exposed
    2 / 15 (13.33%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    4
    Tooth abscess
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    3
    Abdominal wall abscess
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    0
    Abscess of eyelid
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Angular cheilitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Infected bite
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Labyrinthitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Lung infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    0
    Urosepsis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Oral herpes
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 15 (33.33%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    5
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    3 / 15 (20.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    3
    0
    1
    Diabetes mellitus
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 4 (25.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Gout
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    0
    1
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Hyponatraemia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Mar 2013
    Amendments 1.0 (dated 22 March 2013) and 1.1 and (dated 12 April 2013) included the following: • Participants were not to be replaced if they discontinued due to disease recurrence. • The requirement to administer gemcitabine 1 hour after TG01 administration was relaxed to allow gemcitabine to be administered on the same day but after TG01. • After completion of gemcitabine treatment, the requirement for participants to discontinue TG01/GM-CSF treatment if they received alternative therapy for pancreatic cancer was removed. • Inclusion criterion for haemoglobin levels was changed from ≥10 g/dL to ≥9 g/dL. • Inclusion criterion for creatinine clearance ≥60 mL/min was changed to a requirement for serum creatinine ≤1.5x upper normal limit (UNL). • Timings for DTH skin test injections and laboratory test evaluations clarified in text. • The requirement to discontinue TG01/GM-CSF if gemcitabine was discontinued was removed. • Addition of collection of a sample for assessment of T-cell response at Week 52. • Removal of assessment for DTH response at end of treatment.
    20 May 2013
    Amendment 2.0 (dated 20 May 2013) included the following: • Increase to maximum number of centres from 2 to 3. • Additional objectives added: To monitor CA19-9 and other biomarker levels. Details added for collection of blood samples and analysis for these endpoints. • Additional inclusion criteria added requiring participants to be expected to receive gemcitabine as adjuvant chemotherapy and for AST/ALT levels to be ≤5xUNL. • Changes to exclusion criteria: participants were not to be excluded if they had experienced significant weight loss before surgery (≥10% weight loss) but were to be excluded if they were unlikely to start chemotherapy within 12 weeks of surgery and/or were not expected to receive 6 cycles of chemotherapy. • Addition of 5-FU/leucovorin as optional adjuvant chemotherapy. • Clarification that chemotherapy was to start no less than 3 weeks after the start of TG01/GM-CSF but no later than 12 weeks after surgery. • Clarification that 6 cycles of chemotherapy were to be administered. • Additional details of assessments added.
    24 Jun 2013
    Amendment 3.0 (dated 24 June 2013) included the following: • Further to addition of 5-FU/leucovorin as optional adjuvant chemotherapy in Amendment 2.0, references to assessments of effects of ‘gemcitabine’ updated to ‘chemotherapy’. • Analysis populations updated.
    17 Jul 2013
    Amendments 4.0 (dated 17 July 2013) and 4.1 (dated 25 September 2013) included the following: • Increase in the maximum number of centres from 3 to 4 and locations specified as Norway and UK. • Secondary objective regarding assessment of safety of TG01/GM-CSF vaccination and adjuvant chemotherapy updated to a primary objective and additional details of endpoints for safety added. • Primary objective regarding assessment of immune response clarified. • Secondary objective of clinical efficacy to be assessed at 2 years. • Exploratory objective regarding Kirsten rat sarcoma viral oncogene homolog status clarified. • Treatment with TG01/GM-CSF to start within 1 to 8 weeks after surgery in Phase I part of the study. • Details of schedule for TG01/GM-CSF treatment after completion of chemotherapy treatment updated and participants who did recur but had a positive immune response during the initial treatment period allowed to continue TG01/GM-CSF treatment. • Criteria regarding granulocyte count for continuation of gemcitabine treatment updated. • Clarification that computed tomography scans should be performed after surgery, every 6 months from start of vaccination and at any time point if indicated although not mandatory. • Details regarding nominated data management group added. • Additional exclusion criteria added excluding participants who planned to receive yellow fever or other live (attenuated) vaccine during the course of the study. • Clarification of SAE reporting timelines.
    30 Apr 2014
    Amendments 5.0, 5.1, and 5.2 (dated 30 April 2014, 06 June 2014, and 04 July 2014 respectively) included the following: • Sponsor name updated from Aptiv Solutions to Targovax AS; contact details updated for Sponsor personnel. • Duration of enrolment and overall study duration updated. • Primary objective and endpoint clarified. • Number of blood samples and total volume of blood collected updated. • Number of participants planned for the Phase II part of the study increased from 12-18 to 18-24 with a maximum of 6 participants in the Concomitant Group. • Clarification of assessments for Main Group. • Addition of criteria for inclusion of participants in a Concomitant Group. • Addition of details of assessments and treatment for participants included in the Concomitant Group and for participants who do not start chemotherapy at all including treatment schedule and schedule of visits. • A survival follow-up added for participants who discontinued before 2 years. • Definition of ‘successful surgical resection’ updated in inclusion criteria. • Clarification of storage conditions after reconstitution of TG01 and GM-CSF. • Assessment of immune response for Concomitant Group added. • Assessment of immune response, CA19-9 levels and levels of other biomarkers at Week 52 and end of study added. • Definitions of analysis populations updated. • Clarification that events that were unequivocally due to disease recurrence were not to be reported as AEs and clarification of when laboratory/vital signs abnormalities should be considered AEs.
    28 Jan 2015
    Amendment 6.0 (dated 28 January 2015) included the following: • Inclusion of prophylactic treatment prior to TG01/GM-CSF administrations after the end of chemotherapy. • Requirement for participants to be observed for 30 minutes after each injection of TG01. • Requirement for the DTH TG01 injection to be given 30 minutes before administration of GM-CSF. • Addition of treatment schedule for participants starting vaccination treatment but receiving chemotherapy later. • Updated details for Sponsor and for Safety Reporting. • Anticipated toxicity and management details updated.
    12 Mar 2015
    Amendment 7.0 (dated 12 March 2015) included the following: • Number of trial centres updated and locations of centres updated to include Spain. • Addition of a new cohort of up to 13 participants (Modified Vaccination Group) to the Phase II part of the study increasing total study duration to 5 years. Addition of all details regarding treatment and assessments for this additional group of participants. • Clarified participants who would constitute the Main Group and the Concomitant Group. • Pre-medication with intravenous anti-histamine treatment added for any participants who exhibited signs of an allergic reaction for all subsequent TG01 administrations. • Definition of acceptable immune response clarified.
    27 Jun 2016
    Amendment 8.0 (dated 27 June 2016) included the following: • Sponsor details updated. • Extension of study to include survival follow-up assessments until last participant last visit in the Modified Vaccination Group. • Number of blood samples and total volume of blood collected updated.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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