Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44365   clinical trials with a EudraCT protocol, of which   7389   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomized phase II study evaluating FOLFIRI + durvalumab vs FOLFIRI + durvalumab and tremelimumab in second-line treatment of patients with advanced gastric or gastro-oesophageal junction adenocarcinoma

    Summary
    EudraCT number
    		 2018-002014-13
    Trial protocol
    		 FR  
    Global end of trial date
    13 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Oct 2025
    First version publication date
    26 Oct 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PRODIGE59-(FFCD1707)-DURIGAST
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03959293
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fédération Francophone de Cancérologie Digestive
    Sponsor organisation address
    7 bd Jeanne d'Arc, Dijon, France, 21000
    Public contact
    Project Manager, Fédération Francophone de Cancérologie Digestive, +33 380393483, marie.moreau@u-bourgogne.fr
    Scientific contact
    Head of biostatistics, Fédération Francophone de Cancérologie Digestive, +33 380668013, karine.le-malicot@u-bourgogne.fr
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jan 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Percentage of patients alive and without progression at 4 months of FOLFIRI plus durvalumab versus FOLFIRI plus durvalumab plus tremelimumab in patients with advanced-stage gastric or gastro-oesophageal junction adenocarcinoma and who progressed after a first line chemotherapy (based on RECIST 1.1 rating scale evaluated by the investigator).
    Protection of trial subjects
    The study complies with the Declaration of Helsinki and the principles of Good Clinical Practice guidelines. Informed consent was obtained prior to inclusion of each patient.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2019
    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
    France: 96
    Worldwide total number of subjects
    96
    EEA total number of subjects
    96
    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)
    61
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Between August 27, 2020 and June 4, 2021, 96 patients in 37 centres were randomised and 92 patients received one or more doses of the treatment (mITT population, n=92, 47 in FD arm and 45 in FDT arm). One patient randomized in the FD arm received the FDT treatment and was analysed in the FDT arm for safety analyses.

    Pre-assignment
    Screening details
    		 Main inclusion criteria were patients aged 18 years or older, histologically proven advanced unresectable (locally advanced or metastatic) gastric/GEJ (Siewert 2 or 3) adenocarcinoma, with progression or intolerance after first-line chemotherapy with fluoropyrimidine plus platinum salt +/- taxane +/- anti-HER2 therapies, PS 0 or 1.

    Period 1
    Period 1 title
    ITT
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FOLFIRI plus durvalumab (FD arm)
    Arm description
    		 FOLFIRI regimen with folinic acid 400 mg/m2, a 5FU bolus 400 mg/m2, continuous 5FU 2400 mg/m2 and irinotecan at 180 mg/m², every 2 weeks. Durvalumab was administered at a dose of 1500 mg, every 4 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    LV5FU2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use , Intravenous use
    Dosage and administration details
    folinic acid 400 mg/m2, a 5FU bolus 400 mg/m2, continuous 5FU 2400 mg/m2

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Irinotecan at 180 mg/m², every 2 weeks

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Durvalumab was administered at a dose of 1500 mg, every 4 weeks

    Arm title
    		 FOLFIRI plus durvalumab and tremelimumab (FDT arm)
    Arm description
    		 FOLFIRI regimen with folinic acid 400 mg/m2, a 5FU bolus 400 mg/m2, continuous 5FU 2400 mg/m2 and irinotecan at 180 mg/m², every 2 weeks. Durvalumab was administered at a dose of 1500 mg, every 4 weeks. Tremelimumab was administered at a dose of 75 mg, every 4 weeks. Tremelimumab was administered for only four cycles
    Arm type
    		 Experimental

    Investigational medicinal product name
    LV5FU2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use , Intravenous use
    Dosage and administration details
    folinic acid 400 mg/m2, a 5FU bolus 400 mg/m2, continuous 5FU 2400 mg/m2

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Irinotecan at 180 mg/m², every 2 weeks

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Durvalumab was administered at a dose of 1500 mg, every 4 weeks

    Investigational medicinal product name
    Tremelimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Tremelimumab was administered at a dose of 75 mg, every 4 weeks for only four cycles

    Number of subjects in period 1
    		FOLFIRI plus durvalumab (FD arm) FOLFIRI plus durvalumab and tremelimumab (FDT arm)
    Started
    48
    48
    Patients not treated
    1 [1]
    3 [2]
    Completed
    47
    45
    Not completed
    1
    3
         Death
    1
    -
         Patients not treated
    -
    3
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: One patient died before the start of treatment
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 3 patients were never treated in the protocol
    Period 2
    Period 2 title
    Treatment period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FOLFIRI plus durvalumab (FD arm)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    LV5FU2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use , Intravenous use
    Dosage and administration details
    folinic acid 400 mg/m2, a 5FU bolus 400 mg/m2, continuous 5FU 2400 mg/m2

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Irinotecan at 180 mg/m², every 2 weeks

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Durvalumab was administered at a dose of 1500 mg, every 4 weeks

    Arm title
    		 FOLFIRI plus durvalumab and tremelimumab (FDT arm)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    LV5FU2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use , Intravenous use
    Dosage and administration details
    folinic acid 400 mg/m2, a 5FU bolus 400 mg/m2, continuous 5FU 2400 mg/m2

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Irinotecan at 180 mg/m², every 2 weeks

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Durvalumab was administered at a dose of 1500 mg, every 4 weeks

    Investigational medicinal product name
    Tremelimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Tremelimumab was administered at a dose of 75 mg, every 4 weeks for only four cycles

    Number of subjects in period 2
    		FOLFIRI plus durvalumab (FD arm) FOLFIRI plus durvalumab and tremelimumab (FDT arm)
    Started
    47
    45
    Completed
    47
    45

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    FOLFIRI plus durvalumab (FD arm)
    Reporting group description
    		 FOLFIRI regimen with folinic acid 400 mg/m2, a 5FU bolus 400 mg/m2, continuous 5FU 2400 mg/m2 and irinotecan at 180 mg/m², every 2 weeks. Durvalumab was administered at a dose of 1500 mg, every 4 weeks

    Reporting group title
    FOLFIRI plus durvalumab and tremelimumab (FDT arm)
    Reporting group description
    		 FOLFIRI regimen with folinic acid 400 mg/m2, a 5FU bolus 400 mg/m2, continuous 5FU 2400 mg/m2 and irinotecan at 180 mg/m², every 2 weeks. Durvalumab was administered at a dose of 1500 mg, every 4 weeks. Tremelimumab was administered at a dose of 75 mg, every 4 weeks. Tremelimumab was administered for only four cycles

    Reporting group values
    		 FOLFIRI plus durvalumab (FD arm) FOLFIRI plus durvalumab and tremelimumab (FDT arm) Total
    Number of subjects
    		 48 48 96
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 30 31 61
        From 65-84 years
    		 18 17 35
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 14 14 28
        Male
    		 34 34 68

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    FOLFIRI plus durvalumab (FD arm)
    Reporting group description
    		 FOLFIRI regimen with folinic acid 400 mg/m2, a 5FU bolus 400 mg/m2, continuous 5FU 2400 mg/m2 and irinotecan at 180 mg/m², every 2 weeks. Durvalumab was administered at a dose of 1500 mg, every 4 weeks

    Reporting group title
    FOLFIRI plus durvalumab and tremelimumab (FDT arm)
    Reporting group description
    		 FOLFIRI regimen with folinic acid 400 mg/m2, a 5FU bolus 400 mg/m2, continuous 5FU 2400 mg/m2 and irinotecan at 180 mg/m², every 2 weeks. Durvalumab was administered at a dose of 1500 mg, every 4 weeks. Tremelimumab was administered at a dose of 75 mg, every 4 weeks. Tremelimumab was administered for only four cycles
    Reporting group title
    FOLFIRI plus durvalumab (FD arm)
    Reporting group description
    		 -

    Reporting group title
    FOLFIRI plus durvalumab and tremelimumab (FDT arm)
    Reporting group description
    		 -

    Primary: 4-months PFS

    		 Close Top of page
    End point title
    		 4-months PFS [1]
    End point description
    End point type
    Primary
    End point timeframe
    within 4 months after the randomization
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study is a non comparative study that is why no inferential statistics are provided
    End point values
    		 FOLFIRI plus durvalumab (FD arm) FOLFIRI plus durvalumab and tremelimumab (FDT arm)
    Number of subjects analysed
    47
    45
    Units: patients
        Patients with progression/death at 4 months
    25
    20
        Patient without progression/death at 4 months
    21
    25
        Patient not evaluable
    1
    0
    No statistical analyses for this end point

    Secondary: Overall Survival

    		 Close Top of page
    End point title
    		 Overall Survival
    End point description
    It was defined by the time between the date of randomization and the date of death (from any cause); Alive patients were censored at the date of last news .
    End point type
    Secondary
    End point timeframe
    18 months
    End point values
    		 FOLFIRI plus durvalumab (FD arm) FOLFIRI plus durvalumab and tremelimumab (FDT arm)
    Number of subjects analysed
    47
    45
    Units: months
        median (confidence interval 95%)
    20.3 (17.97 to 21.95)
    23.16 (17.91 to 23.49)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected before each cycle of chemotherapy systematically during the whole protocol of treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTC
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    FOLFIRI plus durvalumab (FD arm)
    Reporting group description
    		 1 patient randomized in the FD arm received Tremelimumb so the patient was considered in the FDT arm for safety

    Reporting group title
    FOLFIRI plus durvalumab and tremelimumab (FDT arm)
    Reporting group description
    		 1 patient randomized in the FD arm received Tremelimumab so the patient was considered in the FDT arm for safety

    Serious adverse events
    		 FOLFIRI plus durvalumab (FD arm) FOLFIRI plus durvalumab and tremelimumab (FDT arm)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 46 (50.00%)
    45 / 46 (97.83%)
         number of deaths (all causes)
    36
    35
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superior vena cava syndrome
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Prostatic operation
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    3 / 46 (6.52%)
    6 / 46 (13.04%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Disability
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 46 (2.17%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen consumption decreased
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (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
    Gastrostomy failure
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrostomy tube site complication
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 46 (2.17%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 46 (2.17%)
    6 / 46 (13.04%)
         occurrences causally related to treatment / all
    1 / 1
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    2 / 46 (4.35%)
    4 / 46 (8.70%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    3 / 46 (6.52%)
    3 / 46 (6.52%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 46 (4.35%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    3 / 46 (6.52%)
    3 / 46 (6.52%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 46 (4.35%)
    6 / 46 (13.04%)
         occurrences causally related to treatment / all
    1 / 2
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium colitis
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 46 (4.35%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 46 (8.70%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Starvation
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 FOLFIRI plus durvalumab (FD arm) FOLFIRI plus durvalumab and tremelimumab (FDT arm)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 46 (97.83%)
    45 / 46 (97.83%)
    Investigations
    ALAT increase
         subjects affected / exposed
    9 / 46 (19.57%)
    9 / 46 (19.57%)
         occurrences all number
    9
    9
    ASAT increase
         subjects affected / exposed
    9 / 46 (19.57%)
    14 / 46 (30.43%)
         occurrences all number
    9
    14
    Creatinine increase
         subjects affected / exposed
    6 / 46 (13.04%)
    4 / 46 (8.70%)
         occurrences all number
    6
    4
    GGT increase
         subjects affected / exposed
    14 / 46 (30.43%)
    15 / 46 (32.61%)
         occurrences all number
    14
    15
    White blood cell decrease
         subjects affected / exposed
    10 / 46 (21.74%)
    13 / 46 (28.26%)
         occurrences all number
    10
    13
    PNN decrease
         subjects affected / exposed
    21 / 46 (45.65%)
    22 / 46 (47.83%)
         occurrences all number
    21
    22
    Lymphocytes decrease
         subjects affected / exposed
    14 / 46 (30.43%)
    17 / 46 (36.96%)
         occurrences all number
    14
    17
    Weight loss
         subjects affected / exposed
    2 / 46 (4.35%)
    7 / 46 (15.22%)
         occurrences all number
    2
    7
    PAL Increase
         subjects affected / exposed
    15 / 46 (32.61%)
    19 / 46 (41.30%)
         occurrences all number
    15
    19
    Platelets decrease
         subjects affected / exposed
    10 / 46 (21.74%)
    10 / 46 (21.74%)
         occurrences all number
    10
    10
    Vascular disorders
    Thromboembolic event
         subjects affected / exposed
    1 / 46 (2.17%)
    4 / 46 (8.70%)
         occurrences all number
    1
    4
    Nervous system disorders
    Cephalgia
         subjects affected / exposed
    4 / 46 (8.70%)
    2 / 46 (4.35%)
         occurrences all number
    4
    2
    Dysgueusia
         subjects affected / exposed
    2 / 46 (4.35%)
    3 / 46 (6.52%)
         occurrences all number
    2
    3
    Sensitive peripheral neuropathy
         subjects affected / exposed
    10 / 46 (21.74%)
    10 / 46 (21.74%)
         occurrences all number
    10
    10
    Nevralgia
         subjects affected / exposed
    3 / 46 (6.52%)
    2 / 46 (4.35%)
         occurrences all number
    3
    2
    Paresthesia
         subjects affected / exposed
    8 / 46 (17.39%)
    7 / 46 (15.22%)
         occurrences all number
    8
    7
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    34 / 46 (73.91%)
    38 / 46 (82.61%)
         occurrences all number
    34
    38
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    36 / 46 (78.26%)
    38 / 46 (82.61%)
         occurrences all number
    36
    38
    Fever
         subjects affected / exposed
    4 / 46 (8.70%)
    3 / 46 (6.52%)
         occurrences all number
    4
    3
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    2 / 46 (4.35%)
    3 / 46 (6.52%)
         occurrences all number
    2
    3
    Constipation
         subjects affected / exposed
    10 / 46 (21.74%)
    11 / 46 (23.91%)
         occurrences all number
    10
    11
    Diarrhoea
         subjects affected / exposed
    25 / 46 (54.35%)
    35 / 46 (76.09%)
         occurrences all number
    25
    35
    Abdominal pain
         subjects affected / exposed
    10 / 46 (21.74%)
    12 / 46 (26.09%)
         occurrences all number
    10
    12
    Stomach pain
         subjects affected / exposed
    9 / 46 (19.57%)
    7 / 46 (15.22%)
         occurrences all number
    9
    7
    Dysphagia
         subjects affected / exposed
    8 / 46 (17.39%)
    8 / 46 (17.39%)
         occurrences all number
    8
    8
    Gastroesophageal reflux
         subjects affected / exposed
    8 / 46 (17.39%)
    2 / 46 (4.35%)
         occurrences all number
    8
    2
    Mucositis
         subjects affected / exposed
    10 / 46 (21.74%)
    21 / 46 (45.65%)
         occurrences all number
    10
    21
    Nausea
         subjects affected / exposed
    31 / 46 (67.39%)
    28 / 46 (60.87%)
         occurrences all number
    31
    28
    Vomiting
         subjects affected / exposed
    15 / 46 (32.61%)
    18 / 46 (39.13%)
         occurrences all number
    15
    18
    Respiratory, thoracic and mediastinal disorders
    Dyspneoa
         subjects affected / exposed
    6 / 46 (13.04%)
    9 / 46 (19.57%)
         occurrences all number
    6
    9
    Cough
         subjects affected / exposed
    5 / 46 (10.87%)
    2 / 46 (4.35%)
         occurrences all number
    5
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    7 / 46 (15.22%)
    12 / 46 (26.09%)
         occurrences all number
    7
    12
    Pruritus
         subjects affected / exposed
    6 / 46 (13.04%)
    9 / 46 (19.57%)
         occurrences all number
    6
    9
    Acneiform rash
         subjects affected / exposed
    4 / 46 (8.70%)
    5 / 46 (10.87%)
         occurrences all number
    4
    5
    Palmar-plantar erythrodysesthesia syndrome
         subjects affected / exposed
    6 / 46 (13.04%)
    7 / 46 (15.22%)
         occurrences all number
    6
    7
    Dry skin
         subjects affected / exposed
    3 / 46 (6.52%)
    4 / 46 (8.70%)
         occurrences all number
    3
    4
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    2 / 46 (4.35%)
    8 / 46 (17.39%)
         occurrences all number
    2
    8
    Hypothyroidism
         subjects affected / exposed
    4 / 46 (8.70%)
    7 / 46 (15.22%)
         occurrences all number
    4
    7
    Musculoskeletal and connective tissue disorders
    Dorsalgia
         subjects affected / exposed
    6 / 46 (13.04%)
    3 / 46 (6.52%)
         occurrences all number
    6
    3
    Myalgia
         subjects affected / exposed
    4 / 46 (8.70%)
    5 / 46 (10.87%)
         occurrences all number
    4
    5
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    13 / 46 (28.26%)
    23 / 46 (50.00%)
         occurrences all number
    13
    23
    Hyperglycemia
         subjects affected / exposed
    7 / 46 (15.22%)
    5 / 46 (10.87%)
         occurrences all number
    7
    5
    Hyperkaliemia
         subjects affected / exposed
    5 / 46 (10.87%)
    6 / 46 (13.04%)
         occurrences all number
    5
    6
    Hypoalbuminemia
         subjects affected / exposed
    4 / 46 (8.70%)
    7 / 46 (15.22%)
         occurrences all number
    4
    7
    Hypocalcemia
         subjects affected / exposed
    7 / 46 (15.22%)
    9 / 46 (19.57%)
         occurrences all number
    7
    9
    Hypokaliemia
         subjects affected / exposed
    2 / 46 (4.35%)
    4 / 46 (8.70%)
         occurrences all number
    2
    4
    Hyponatremia
         subjects affected / exposed
    4 / 46 (8.70%)
    6 / 46 (13.04%)
         occurrences all number
    4
    6

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/38573643
    http://www.ncbi.nlm.nih.gov/pubmed/33358124
    http://www.ncbi.nlm.nih.gov/pubmed/35625947
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Dec 07 18:41:58 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA