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    Clinical Trial Results:
    A ROLLOVER PROTOCOL FOR PATIENTS WHO RECEIVED TREMELIMUMAB (CP-675,206) IN OTHER PROTOCOLS

    Summary
    EudraCT number
    		 2008-000989-23
    Trial protocol
    		 GB   IT  
    Global end of trial date
    27 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Sep 2024
    First version publication date
    06 Sep 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D4881C00024
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00378482
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca Clinical Study Information Center
    Sponsor organisation address
    Milbourn Science Park, Royston, United Kingdom, SG8 6EE
    Public contact
    Global Clinical Lead, AstraZeneca Clinical Study Information Center, +1 8772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca Clinical Study Information Center, +1 8772409479, information.center@astrazeneca.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
    18 Jun 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To allow access to tremelimumab for subjects who received tremelimumab in other trials.
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonization /Good Clinical Practice and applicable regulatory requirements and the AstraZeneca policy on Bioethics.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Mar 2008
    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
    Italy: 1
    Country: Number of subjects enrolled
    United States: 35
    Country: Number of subjects enrolled
    United Kingdom: 2
    Worldwide total number of subjects
    38
    EEA total number of subjects
    1
    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)
    24
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First subject enrolled: 05 Mar 2007; Data Cut-off: 18 Jun 2020. This was a multicenter study conducted at 11 study centers in 3 countries (the United Kingdom, the United States of America and Italy).

    Pre-assignment
    Screening details
    		 Total Consented/screened 38 subjects (1 of which was dead before enter any treatment), so total entered treatment 37 subjects Subjects were assigned to treatment if they met all inclusion. 32 subjects withdrawn from this study. 6 subjects completed the study. Final Efficacy/Safety analysis 37 subjects.

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

    Arms
    Arm title
    		 Tremelimumab 15mg/kg
    Arm description
    		 All Patients
    Arm type
    		 NA

    Investigational medicinal product name
    TREMELIMUMAB
    Investigational medicinal product code
    MEDI1123
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15 mg/kg milligram(s)/kilogram

    Number of subjects in period 1
    		Tremelimumab 15mg/kg
    Started
    38
    Completed
    6
    Not completed
    32
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    4
         Physician decision
    9
         Adverse event, non-fatal
    9
         Lost to follow-up
    1
         Lack of efficacy
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tremelimumab 15mg/kg
    Reporting group description
    		 All Patients

    Reporting group values
    		 Tremelimumab 15mg/kg Total
    Number of subjects
    		 38 38
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0
        Between 18 and 65 years
    		 24 24
        >=65 years
    		 14 14
    Sex: Female, Male
    Units: Participants
        Female
    		 11 11
        Male
    		 27 27
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 38 38
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Tremelimumab 15mg/kg
    Reporting group description
    		 All Patients

    Subject analysis set title
    All Patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All Patients enrolled

    Primary: Safety Endpoints: • Serious adverse events • Grade 3 or 4 tremelimumab-related adverse events • Immune-mediated adverse events • Hypersensitivity reactions to tremelimumab.

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    End point title
    		 Safety Endpoints: • Serious adverse events • Grade 3 or 4 tremelimumab-related adverse events • Immune-mediated adverse events • Hypersensitivity reactions to tremelimumab.
    End point description
    End point type
    Primary
    End point timeframe
    as long as required
    End point values
    		 Tremelimumab 15mg/kg All Patients
    Number of subjects analysed
    37
    37
    Units: Participants
    37
    37
    Statistical analysis title
    		 Summaries of safety data
    Statistical analysis description
    No quantification or analysis performed for this outcome
    Comparison groups
    Tremelimumab 15mg/kg v All Patients
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0
    Method
    		 N/A
    Confidence interval

    Primary: Efficacy Endpoints: • Tumor status: alive with disease (AWD) or no evidence of disease (NED) • Survival

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    End point title
    		 Efficacy Endpoints: • Tumor status: alive with disease (AWD) or no evidence of disease (NED) • Survival
    End point description
    End point type
    Primary
    End point timeframe
    End of study per participant
    End point values
    		 Tremelimumab 15mg/kg All Patients
    Number of subjects analysed
    37
    37
    Units: Participants
        No evidence of disease
    19
    19
        Evidence of disease
    17
    17
        Indeterminate
    1
    1
    Statistical analysis title
    		 Summary of tumor status
    Statistical analysis description
    Single-arm, no statistical testing performed
    Comparison groups
    Tremelimumab 15mg/kg v All Patients
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0
    Method
    		 N/A
    Confidence interval

    Secondary: Disease Free Survival

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    End point title
    		 Disease Free Survival
    End point description
    Time from the first dose of study drug to the earliest date of evidence of disease (based on tumor status assessment) or death, whichever occurred first
    End point type
    Secondary
    End point timeframe
    Varied per participant
    End point values
    		 Tremelimumab 15mg/kg All Patients
    Number of subjects analysed
    37
    37
    Units: Days
        median (confidence interval 95%)
    3.0 (2.9 to 11.8)
    3.0 (2.9 to 11.8)
    Statistical analysis title
    		 Summary of Disease-Free Survival
    Statistical analysis description
    Single-arm study with no statistical testing
    Comparison groups
    Tremelimumab 15mg/kg v All Patients
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0
    Method
    		 N/A
    Parameter type
    		 N/A
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    13 years, 3 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Tremelimumab 15mg/kg
    Reporting group description
    		 All Patients

    Serious adverse events
    		 Tremelimumab 15mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 37 (10.81%)
         number of deaths (all causes)
    11
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Medical Device Complication
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary Granuloma
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Tremelimumab 15mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 37 (13.51%)
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    4 / 37 (10.81%)
         occurrences all number
    12
    Pruritus
         subjects affected / exposed
    3 / 37 (8.11%)
         occurrences all number
    3
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 37 (5.41%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Dec 2019
    Incorporate the 2012 Protocol Administrative change (dated 05 April 2012) which included a change in Sponsor, compound name, and study number. Align the Protocol with the current tremelimumab Investigator’s Brochure (IB) specifically in relation to safety. Update the toxicity management in the clinical protocol in line with updates being made across the clinical program, and introduce Dosing Modification and Toxicity Management Guidelines (TMG), which is provided as an Annex to the clinical protocol.

    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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