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    Clinical Trial Results:
    A national prospective study of patients with hepatitis induced by immune checkpoint inhibitors; Characterization of liver injury, outcome of therapy and randomization to either prednisolone or mycophenolate mofetil treatment in case of relapse

    Summary
    EudraCT number
    		 2020-004483-26
    Trial protocol
    		 DK  
    Global end of trial date
    06 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Nov 2025
    First version publication date
    16 Nov 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AA2032
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04810156
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 The Danish Medical Agencies: 2020092719, Ethical Committee of the Capital Region of Denmark: H-20062916, the Capital Region's Data Unit: P-2020-959
    Sponsors
    Sponsor organisation name
    National Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology
    Sponsor organisation address
    Borgmester Ib Juuls Vej 9, 4th floor, Herlev, Denmark, 2730
    Public contact
    Professor Inge Marie Svane, MD, PhD, National Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, 45 38682971, Inge.Marie.Svane@regionh.dk
    Scientific contact
    Professor Inge Marie Svane, MD, PhD, National Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, 45 38682131, Inge.Marie.Svane@regionh.dk
    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
    06 Sep 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Sep 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Sep 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study is performed to evaluate the crucially important question of which patients with immune-related hepatitis will respond to standard treatment with steroids and who needs treatment with a second line immunosuppressive agent in this case steroids plus mycophenolate mofetil. Treatment efficacy is evaluated as the percentage reduction in liver transaminases or bilirubin, assessed by the number of days to achieve a ≥20% reduction in either ALT, AST, or bilirubin.
    Protection of trial subjects
    The clinical trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. The study protocol, informed consent forms, and all patient materials were reviewed and approved by the Ethics Committee and the Danish Medical Agency prior to trial initiation. Patient confidentiality was maintained by the use of coded identifiers, and all personal data were handled in compliance with the data protection legislation through the use of the RedCap database. Written informed consent was obtained from all patients before any study-related procedures. In addition to the general study consent, participants provided specific written consent for liver biopsy and for the collection and analysis of blood samples for investigational purposes. Patients were fully informed of the nature, purpose, and potential risks of these procedures, as well as their right to withdraw consent at any time without consequences for their future medical care. Patients receiving anticoagulant therapy had treatment temporarily paused according to local clinical guidelines before undergoing liver biopsy to minimize the risk of bleeding. All patients were offered prophylactic therapy (proton pump inhibitors, calcium and vitamin D supplements) to reduce risk of gastroduodenal ulcers and osteoporosis. The protection and safety of trial patients were monitored by the GCP unit through regular monitoring visits, including safety reporting, and adherence to approved procedures. All adverse events were recorded and evaluated for seriousness and causality.
    Background therapy
    		 Immune-related hepatitis is among the most common immune-related adverse events (irAEs) associated with immune checkpoint inhibitor (ICI) therapy in patients with cancer. It accounts for approximately 20% of fatal irAE cases and often necessitates discontinuation of ICIs. The condition is characterized by elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or alkaline phosphatase (ALP) levels, with or without increased bilirubin, following ICI exposure and after exclusion of other causes of liver injury. Ir-hepatitis is observed in up to 15–23% of patients treated with a combination of anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) and anti-programmed cell death protein-1 (anti-PD-1) with grade 3-4 occurring in 6–12% of patients, whereas only 4–9% of patients treated with monotherapy develop ir-hepatitis (grade 3–4: 1–4%). The underlying mechanisms remain incompletely understood but are thought to reflect immune activation pathways responsible for the antitumor effects of ICIs. According to international guidelines, grade 3–4 ir-hepatitis requires permanent discontinuation of ICIs, hospitalization, and treatment with intravenous methylprednisolone (1–2 mg/kg/day). However, 23–35% of patients are steroid-resistant or steroid-dependent and require additional immunosuppressive therapy. Mycophenolate mofetil (MMF) is the recommended second-line treatment, whereas the more T-cell–targeted immunosuppressant tacrolimus is considered third line. To date, no clinical study has directly compared the efficacy of MMF and tacrolimus in patients with steroid-resistant ir-hepatitis. This prospective study aimed to characterize immune-related hepatitis and its clinical phenotypes and to evaluate treatment outcomes in patients with ICI-induced grade 3–4 ir-hepatitis.
    Evidence for comparator
    		 The study was initially designed to randomize patients with steroid-resistant or steroid-dependent immune-related hepatitis to receive additional treatment with either mycophenolate mofetil (MMF) or tacrolimus, respectively. However, due to a slower-than-expected recruitment rate, this randomization was cancelled. Instead, these patients received MMF as standard-of-care as proposed by international guidelines. In a subsequent protocol amendment, the study design was modified to include randomization of patients with relapsing immune-related hepatitis (also referred to as steroid-dependent cases) to receive either an increased dose of corticosteroids or MMF (Cohort B). Nevertheless, this part of the study was never initiated due to limited available resources.
    Actual start date of recruitment
    26 Apr 2021
    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
    Denmark: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    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)
    12
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from Apr 2021 to Jan 2024 at the Departments of Oncology and Gastroenterology at Herlev Hospital, Rigshospitalet, and Aarhus University Hospital, Denmark. 47 patients were screened; 37 patients met criteria and started therapy; 3 patients were later excluded (inaccessible liver biopsy, n=2, and non-adherence to therapy, n=1)

    Pre-assignment
    Screening details
    		 Patients with solid cancers who developed ICI-induced ≥grade 3 hepatitis within 6 months and were willing to undergo liver biopsy were screened by physical exam, detailed history, CT/US scan and comprehensive blood tests.

    Pre-assignment period milestones
    Number of subjects started
    		 37 [1]
    Number of subjects completed
    		 34

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Physician decision: 2
    Reason: Number of subjects
    		 non-compliance: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Three patients were later excluded due to inaccessible liver biopsy and non-adherence to treatment and therefore not included in the trial data.
    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Arm title
    		 Immune-related hepatitis
    Arm description
    		 All patients received intravenous methylprednisolone at a dose of 2 mg/kg/day for a minimum of 72 hours (three boluses). Treatment response was evaluated after 72 hours of steroid initiation. In patients with mixed or cholestatic drug-induced liver injury phenotypes, additional weight-based oral ursodeoxycholic acid (UDCA) was administered, and treatment response was re-evaluated on Day 7. Patients demonstrating adequate response transitioned to a tapering regimen of oral prednisolone. In cases of insufficient response, defined as <20% decline in ALT, AST, or bilirubin, mycophenolate mofetil (MMF) was initiated as second-line therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    prednisolone
    Investigational medicinal product code
    Other name
    methylprednisolone, solu-medrol, steroids
    Pharmaceutical forms
    Capsule, Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    All patients discontinued ICI therapy and received IV methylprednisolone (Solu-Medrol) as a loading dose of 2 mg/kg/day for a minimum of 72 hours (three boluses) before treatment evaluation. For patients with a mixed or cholestatic drug-induced liver injury phenotype, additional weight-based peroral doses of ursodeoxycholic acid (UDCA) were administered. These UDCA-patients were evaluated twice (after 72 hours and day 7) due to the known longer time to response in these phenotypes. Once a response was achieved (defined as a reduction of more than 20% in ALT, AST, or bilirubin levels), patients transitioned to a tapering regimen of oral prednisolone for 4–6 weeks (the dosage of prednisolone may vary according to the levels of liver enzymes, other irAEs, and patient condition).

    Investigational medicinal product name
    mycophenolate mofetil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment was initiated at 500 mg twice daily on Day 1, increased to 1000 mg twice daily on Day 2. This dosage was continued until 8 weeks after discontinuation of prednisolone. Dose reductions were permitted in the event of adverse reactions or tolerability issues.

    Number of subjects in period 1
    		Immune-related hepatitis
    Started
    34
    Completed
    34

    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
    		 34 34
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 12 12
        From 65-84 years
    		 22 22
        85 years and over
    		 0 0
        overall trial
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 70 (37 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 20 20
    Liver metastasis
    Units: Subjects
        Yes
    		 10 10
        No
    		 24 24
    Alcohol consumption, units/week
    Units: Subjects
        0-2
    		 26 26
        3-6
    		 3 3
        ≥7
    		 5 5
    Subject analysis sets

    Subject analysis set title
    Steroid-responders
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients demonstrating a ≥20% reduction of either ALT, AST, or bilirubin within 72 hours were defined as "steroid-responders". Notably, patients with mixed or cholestatic phenotypes (see definition below), who had a potentially slower treatment response, were included as steroid-responders if they achieved ≥20% reduction of either ALT, AST, or bilirubin within 7 days.

    Subject analysis set title
    Steroid-unresponsive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients who did not have a ≥20% reduction of ALT, AST, or bilirubin levels at the 72-hour evaluation or day 7 (mixed and cholestatic DILI) were classified as "steroid-unresponsive".

    Subject analysis set title
    Steroid-dependent
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients experiencing a recurrence of CTCAE grade ≥2 ir-hepatitis during tapering of prednisolone or within four weeks of discontinuing prednisolone were characterized as "steroid-dependent".

    Subject analysis sets values
    		 Steroid-responders Steroid-unresponsive Steroid-dependent
    Number of subjects
    20
    6
    8
    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)
    7
    4
    1
        From 65-84 years
    13
    2
    7
        85 years and over
    0
    0
    0
        overall trial
    0
    0
    0
    Age continuous
    Units: years
        median (full range (min-max))
    65 (37 to 75)
    61 (41 to 80)
    71 (53 to 80)
    Gender categorical
    Units: Subjects
        Female
    11
    3
    0
        Male
    9
    3
    8
    Liver metastasis
    Units: Subjects
        Yes
    4
    4
    2
        No
    16
    2
    6
    Alcohol consumption, units/week
    Units: Subjects
        0-2
    18
    5
    3
        3-6
    0
    1
    2
        ≥7
    2
    0
    3

    End points

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    End points reporting groups
    Reporting group title
    Immune-related hepatitis
    Reporting group description
    		 All patients received intravenous methylprednisolone at a dose of 2 mg/kg/day for a minimum of 72 hours (three boluses). Treatment response was evaluated after 72 hours of steroid initiation. In patients with mixed or cholestatic drug-induced liver injury phenotypes, additional weight-based oral ursodeoxycholic acid (UDCA) was administered, and treatment response was re-evaluated on Day 7. Patients demonstrating adequate response transitioned to a tapering regimen of oral prednisolone. In cases of insufficient response, defined as <20% decline in ALT, AST, or bilirubin, mycophenolate mofetil (MMF) was initiated as second-line therapy.

    Subject analysis set title
    Steroid-responders
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients demonstrating a ≥20% reduction of either ALT, AST, or bilirubin within 72 hours were defined as "steroid-responders". Notably, patients with mixed or cholestatic phenotypes (see definition below), who had a potentially slower treatment response, were included as steroid-responders if they achieved ≥20% reduction of either ALT, AST, or bilirubin within 7 days.

    Subject analysis set title
    Steroid-unresponsive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients who did not have a ≥20% reduction of ALT, AST, or bilirubin levels at the 72-hour evaluation or day 7 (mixed and cholestatic DILI) were classified as "steroid-unresponsive".

    Subject analysis set title
    Steroid-dependent
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients experiencing a recurrence of CTCAE grade ≥2 ir-hepatitis during tapering of prednisolone or within four weeks of discontinuing prednisolone were characterized as "steroid-dependent".

    Primary: Response rate to steroids

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    End point title
    		 Response rate to steroids [1]
    End point description
    Response to steroid therapy, defined as the time (in days) from treatment initiation to the first occurrence of a ≥20% reduction in at least one of the following laboratory parameters: ALT, AST, or bilirubin. A response was considered achieved if this reduction occurred within three days of starting treatment.
    End point type
    Primary
    End point timeframe
    Apr 2021 to Sep 2024
    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: descriptive statistic - no statistical analysis for these points
    End point values
    		 Immune-related hepatitis
    Number of subjects analysed
    34
    Units: subjects
    34
    No statistical analyses for this end point

    Secondary: Time to transition to oral prednisolone and discharge

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    End point title
    		 Time to transition to oral prednisolone and discharge
    End point description
    End point type
    Secondary
    End point timeframe
    apr 2021 - sept 2024
    End point values
    		 Immune-related hepatitis
    Number of subjects analysed
    34
    Units: days
    34
    No statistical analyses for this end point

    Secondary: Recurrence rate of ir-hepatitis

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    End point title
    		 Recurrence rate of ir-hepatitis
    End point description
    The number of patients experiencing relapse of ir-hepatitis CTCAE grade ≥2, excluding other aetiologies for liver injury.
    End point type
    Secondary
    End point timeframe
    apr 2021 - sept 2024
    End point values
    		 Immune-related hepatitis
    Number of subjects analysed
    34
    Units: subjects
    34
    No statistical analyses for this end point

    Other pre-specified: cumulative steroid equivalents and mycophenolate mofetil doses

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    End point title
    		 cumulative steroid equivalents and mycophenolate mofetil doses
    End point description
    cumulative steroid equivalents and MMF doses
    End point type
    Other pre-specified
    End point timeframe
    apr 2021 - sept 2024
    End point values
    		 Immune-related hepatitis
    Number of subjects analysed
    34
    Units: mg
    34
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected and reported over a 3-month follow-up period from initiation of steroids for all patients. For patients who received mycophenolate mofetil (MMF), safety data were collected and reported up to 6 months following MMF initiation
    Adverse event reporting additional description
    AEs of Grade ≥ 3 and considered MMF-related were recorded in the eCRF and patient electronic journal at each consultation and followed until improvement to Grade ≤ 2 for over 10 weeks. Non-serious AEs not meeting the protocol-defined reporting threshold (Grade ≥3 and drug-related) were recorded in the CTCAE log. All drug-related AEs are reported:
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    all patients
    Reporting group description
    		 Patients with cancer and suspected Grade ≥3 immune-related hepatitis induced by immune checkpoint inhibitor therapy. All patients were treated with high-dose steroids (methylprednisolone 2 mg/kg, minimum of three doses) followed by a prednisolone tapering regimen. Patients who were steroid-resistant, steroid-unresponsive, or steroid-dependent received subsequent treatment with mycophenolate mofetil (MMF) at a total daily dose of 1000–2000 mg. 34 patients were included for study analyses. Three patients were excluded due to either inaccessibility for liver biopsy (n=2) or non-adherence to study treatment (n=1) - these patients are not included in the safety analysis.

    Serious adverse events
    		 all patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 34 (5.88%)
         number of deaths (all causes)
    7
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Transient ischaemic attack
    Additional description: Unrelated to treatment. Known risk factors for TIA. The patient recovered without sequelae following standard medical management. No other serious adverse events were reported.
    alternative dictionary used: CTCAE 5.0
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diverticulitis intestinal perforated
    Additional description: The patient had intestinal diverticulitis with perforation on Day 2 after steroid initiation. Managed conservatively, fully recovered. Unrelated to treatment. Later excluded from efficacy analysis due to liver biopsy contraindication.
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 all patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 34 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Arthralgia
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    0
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Dyspnoea
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Oedema
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Tremor
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    28 / 34 (82.35%)
         occurrences all number
    28
    Anxiety
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Mood altered
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3
    Thrombocytopenia
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Eye disorders
    Vision blurred
         subjects affected / exposed
    6 / 34 (17.65%)
         occurrences all number
    6
    Dry eye
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    15 / 34 (44.12%)
         occurrences all number
    15
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    8 / 34 (23.53%)
         occurrences all number
    8
    Diarrhoea
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Epigastric discomfort
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3
    Fat redistribution
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    4
    Infections and infestations
    Neutropenia
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences all number
    1
    Infection
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3

    More information

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

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    13 Jun 2022
    The planned randomization was cancelled due to low recruitment. The trial was resumed as a non-randomized, single-arm study in which all participants received corticosteroids as standard of care. Patients with steroid-unresponsive or steroid-dependent disease received mycophenolate mofetil as second-line immunosuppression, according to international guidelines. No patients received tacrolimus as second-line immunosuppresive.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    A relatively small number of patients, especially in subgroups of steroid-unresponsive patients, hinders definitive conclusions
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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