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    Clinical Trial Results:
    The CAPER study: A Phase Ib clinical trial of Cyclophosphamide And PEmbrolizumab in metastatic Renal cell carcinoma (CAPER Trial)

    Summary
    EudraCT number
    		 2018-004314-17
    Trial protocol
    		 GB  
    Global end of trial date
    28 Apr 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    20 Sep 2024
    First version publication date
    30 Jun 2024
    Other versions
    		 v1
    Version creation reason
    • Changes to summary attachments
    Attached final statistical analysis report has been updated to the current report
    Summary report(s)
    		 CAPER Final SAR V2.0

    Trial information

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    Trial identification
    Sponsor protocol code
    CFTSp148
    Additional study identifiers
    ISRCTN number
    		 ISRCTN95900287
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Christie NHS Foundation Trust
    Sponsor organisation address
    550 Wilmslow Road, Manchester, United Kingdom, M20 4BX
    Public contact
    Dr Clare Griffin, Research Integrity and Governance Manager, The Christie NHS Foundation Trust, clare.griffin1@nhs.net
    Scientific contact
    Dr Clare Griffin, Research Integrity and Governance Manager, The Christie NHS Foundation Trust, clare.griffin1@nhs.net
    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
    01 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Apr 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Apr 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate whether the combination of oral metronomic (low doses of drug taken more often) cyclophosphamide and pembrolizumab will lead to objective tumour responses (a measurable shrinking of the tumour) in metastatic clear cell renal carcinoma (cancer of kidney cells that have spread to other parts of the body) patients who have previously progressed on immuno-oncology therapy (therapy that stimulates the immune system to fight cancer).
    Protection of trial subjects
    Central and site monitoring is conducted to ensure protection of patients participating in the trial, and that trial procedures, trial intervention administration, and laboratory and data collection processes are of high quality and meet sponsor and, when appropriate, regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jan 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    0
    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)
    4
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Start of screening is defined as when a patient has been provided with the PIS and ICF and has had a discussion with their clinical care team regarding their treatment and the possibility of entry into a trial requiring additional tests.

    Period 1
    Period 1 title
    Main Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Cyclophosphamide and Pembrolizumab
    Arm description
    		 Cyclophosphamide • Oral tablet • 50mg once daily (OD) dosing (metronomic schedule) • 21-day run-in period prior to commencing pembrolizumab • Continuous dosing in 21-day cycles throughout (Q3W) Pembrolizumab • IV infusion • 200mg flat dosing Q3W • Commenced at C2D1 (following cyclophosphamide run-in) • Continuous dosing Q3W throughout
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    • Oral tablet • 50mg once daily (OD) dosing (metronomic schedule) • 21-day run-in period prior to commencing pembrolizumab • Continuous dosing in 21-day cycles throughout (Q3W)

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    • IV infusion • 200mg flat dosing Q3W • Commenced at C2D1 (following cyclophosphamide run-in) • Continuous dosing Q3W throughout

    Number of subjects in period 1
    		Cyclophosphamide and Pembrolizumab
    Started
    9
    Completed
    0
    Not completed
    9
         Disease Progression
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main Trial
    Reporting group description
    		 -

    Reporting group values
    		 Main Trial Total
    Number of subjects
    		 9 9
    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)
    		 4 4
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.1 ( 9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 7 7
    Ethnicity
    Units: Subjects
        White British
    		 7 7
        Any other white background
    		 1 1
        Asian or Asian British: Indian
    		 1 1
    Smoking Status
    Units: Subjects
        Current Smoker
    		 1 1
        Ex-smoker
    		 6 6
        Never Smoked
    		 2 2
    Alcohol status
    Units: Subjects
        Regular
    		 2 2
        Sporadic
    		 4 4
        None
    		 3 3
    ECOG performance
    Units: Subjects
        Zero
    		 6 6
        One
    		 3 3
    Protein
    Units: Subjects
        Negative
    		 9 9
    Glucose
    Units: Subjects
        Negative
    		 6 6
        Positive
    		 3 3
    Blood
    Units: Subjects
        Negative
    		 4 4
        Trace
    		 4 4
        Positive
    		 1 1
    Presence of sarcomatoid component
    Units: Subjects
        Yes
    		 1 1
        No
    		 7 7
        Missing
    		 1 1
    Current TNM Stage
    Units: Subjects
        TX/NX/M1
    		 1 1
        TX/N0/M1
    		 2 2
        TX/N1/M1
    		 2 2
        T1/N0/M1
    		 1 1
        T3/NX/M1
    		 1 1
        T4/N0/M1
    		 1 1
        T4/N1/M1
    		 1 1
    Fuhrman Grade
    Units: Subjects
        Two
    		 1 1
        Three
    		 3 3
        Four
    		 4 4
        Missing
    		 1 1
    IMDC prognostic group classification
    Units: Subjects
        Zero
    		 2 2
        One
    		 2 2
        Two
    		 4 4
        Three
    		 1 1
    Surgery for RCC
    Units: Subjects
        Yes
    		 7 7
        No
    		 2 2
    Radiotherapy for RCC
    Units: Subjects
        Yes
    		 1 1
        No
    		 8 8
    Systemic therapy for RCC
    Units: Subjects
        Yes
    		 9 9
    Nitrites
    Units: Subjects
        Negative
    		 9 9
    Number of years smoking
    This is only for the seven people that smoked.
    Units: Years
        arithmetic mean (standard deviation)
    		 21.1 ( 14.2 ) -
    Number of cigarettes per day
    This is for the seven smokers
    Units: Cigarettes
        arithmetic mean (standard deviation)
    		 12.4 ( 9.9 ) -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 169.8 ( 9.8 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 84.5 ( 19.2 ) -
    Systolic Blood Pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 132.7 ( 8 ) -
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 75.1 ( 5.8 ) -
    Temperature
    Units: degrees Celsius
        arithmetic mean (standard deviation)
    		 36.5 ( 0.5 ) -
    Respiratory rate
    Units: breaths per minute
        arithmetic mean (standard deviation)
    		 15.9 ( 2.3 ) -
    Pulse rate
    Units: beats per minute
        arithmetic mean (standard deviation)
    		 81 ( 9.8 ) -
    Oxygen saturation
    Units: percentage
        arithmetic mean (standard deviation)
    		 97.3 ( 1.5 ) -
    Haemoglobin
    Units: g/L
        arithmetic mean (standard deviation)
    		 135.3 ( 7.5 ) -
    White blood cell count
    Units: x10^9/L
        arithmetic mean (standard deviation)
    		 9.5 ( 1.5 ) -
    Platelets
    Units: x10^9/L
        arithmetic mean (standard deviation)
    		 295.4 ( 79.3 ) -
    Red blood cell count
    Units: x10^9/L
        arithmetic mean (standard deviation)
    		 4.9 ( 0.4 ) -
    Haematocrit
    Units: L/L
        arithmetic mean (standard deviation)
    		 0.4 ( 0 ) -
    Prothrombin time
    Units: seconds
        arithmetic mean (standard deviation)
    		 11.7 ( 0.9 ) -
    Absolute neutrophil count
    Units: x10^9/L
        arithmetic mean (standard deviation)
    		 6.8 ( 1.4 ) -
    Eosinophils
    Units: x10^9/L
        arithmetic mean (standard deviation)
    		 0.2 ( 0.1 ) -
    Basophils
    Units: x10^9/L
        arithmetic mean (standard deviation)
    		 0 ( 0 ) -
    Lymphocytes
    Units: x10^9/L
        arithmetic mean (standard deviation)
    		 1.8 ( 0.4 ) -
    Monocyte levels
    Units: x10^9/L
        arithmetic mean (standard deviation)
    		 0.5 ( 0.2 ) -
    INR
    Units: INR
        arithmetic mean (standard deviation)
    		 1.0 ( 0.1 ) -
    Sodium
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 136.9 ( 2 ) -
    Potassium
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 4.6 ( 0.4 ) -
    Urea
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 6.5 ( 3 ) -
    Creatinine
    Units: µmol/L
        arithmetic mean (standard deviation)
    		 98.4 ( 22.7 ) -
    GFR
    Units: ml/min
        arithmetic mean (standard deviation)
    		 68 ( 21.5 ) -
    Alkaline phosphatase
    Units: IU/L
        arithmetic mean (standard deviation)
    		 98.9 ( 23.4 ) -
    Bilirubin
    Units: µmol/L
        arithmetic mean (standard deviation)
    		 7.4 ( 4 ) -
    Calcium – unadjusted
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 2.4 ( 0.2 ) -
    Magnesium
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 0.8 ( 0.1 ) -
    Phosphate
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 1.1 ( 0.2 ) -
    Alanine aminotransferase
    Units: ul/L
        arithmetic mean (standard deviation)
    		 25.2 ( 17.6 ) -
    Lactate dehydrogenase
    Units: IU/L
        arithmetic mean (standard deviation)
    		 183.1 ( 31.9 ) -
    Total protein
    Units: g/L
        arithmetic mean (standard deviation)
    		 70.1 ( 3.1 ) -
    Albumin
    Units: g/L
        arithmetic mean (standard deviation)
    		 42.2 ( 3.6 ) -
    Glucose
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 9.2 ( 5.8 ) -
    Free T4
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 16.4 ( 3.1 ) -
    Thyroid stimulating hormone
    Units: mIU/L
        arithmetic mean (standard deviation)
    		 2.6 ( 1.4 ) -
    Specific gravity
    Units: Specific gravity
        arithmetic mean (standard deviation)
    		 114.2 ( 339.7 ) -
    pH
    Units: pH
        arithmetic mean (standard deviation)
    		 6 ( 0.6 ) -
    Time from initial diagnosis to registration
    Units: days
        arithmetic mean (standard deviation)
    		 2589.6 ( 1630.3 ) -
    Time from metastatic disease confirmation to registration
    Units: days
        arithmetic mean (standard deviation)
    		 1728.9 ( 1344.8 ) -
    Sum of lesion diameter
    Units: mm
        arithmetic mean (standard deviation)
    		 94.7 ( 58.5 ) -
    Activated Partial Thromboplastin Time
    Units: Seconds
        arithmetic mean (standard deviation)
    		 26.9 ( 3.5 ) -

    End points

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    End points reporting groups
    Reporting group title
    Cyclophosphamide and Pembrolizumab
    Reporting group description
    		 Cyclophosphamide • Oral tablet • 50mg once daily (OD) dosing (metronomic schedule) • 21-day run-in period prior to commencing pembrolizumab • Continuous dosing in 21-day cycles throughout (Q3W) Pembrolizumab • IV infusion • 200mg flat dosing Q3W • Commenced at C2D1 (following cyclophosphamide run-in) • Continuous dosing Q3W throughout

    Primary: Object response as per RECIST

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    End point title
    		 Object response as per RECIST [1]
    End point description
    End point type
    Primary
    End point timeframe
    The primary endpoint of the trial is ORR according to RECIST version 1.1 from baseline until end of study or death, and will be calculated using the best response achieved during study treatment for each participant.
    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: Due to the small number of patients only descriptive analysis was performed for this endpoint.
    End point values
    		 Cyclophosphamide and Pembrolizumab
    Number of subjects analysed
    9
    Units: Participants
        Progressive Disease
    3
        Stable Disease
    6
    No statistical analyses for this end point

    Secondary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    End point type
    Secondary
    End point timeframe
    PFS, measured from the time of first treatment to the time of first documented progression or the censor date in months
    End point values
    		 Cyclophosphamide and Pembrolizumab
    Number of subjects analysed
    9
    Units: Months
        median (confidence interval 95%)
    3.9 (1.2 to 8.3)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    12 month survival probability is reported as the median survival time could not be calculated.
    End point type
    Secondary
    End point timeframe
    OS, defined as the time from first treatment to death by any cause in months
    End point values
    		 Cyclophosphamide and Pembrolizumab
    Number of subjects analysed
    9
    Units: Probability
        number (confidence interval 95%)
    0.9 (0.4 to 1.0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Safety and tolerability of the combination of cyclophosphamide and pembrolizumab, reported following the CTCAE version 5 guidelines
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Safety
    Reporting group description
    		 Participants had to have had at least once dose of medication.

    Serious adverse events
    		 Safety
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 9 (22.22%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 9 (11.11%)
         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
    		 Safety
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    Investigations
    Biopsy
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Nervous system disorders
    Hemiparesis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Neuralgia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    5
    Mucosal inflammation
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Frequent bowel movements
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Epistaxis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Haemoptysis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Nasal congestion
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Rash
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Psychiatric disorders
    Affect lability
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Irritability
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Musculoskelatal pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    COVID-19
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Infection
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Onychomycosis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Tooth abscess
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Hypercalcaemia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jul 2021
    This version was no approved by the MHRA Main changes were: - Clarification on End of Trial Definition in line with LCTC protocol template - Update to inclusion criterion 12: male participants contraception/abstinence timeframe from 180 days to 210 days; and inclusion criterion 13: female participants contraception/abstinence timeframe from 180 days to 150 days - Update to Exclusion criterion 14 with inclusion of interstitial lung disease to align with MSD protocol template - Update to male participants contraception/abstinence timeframe from 180 days to 210 days; and female participants contraception/abstinence timeframe from 180 days to 150 days - Update to dose modification guidance for pembrolizumab for immune-related AEs to align with MSD protocol template - Update to dose modification & toxicity management table for pembrolizumab for immune-related AEs to align with MSD protocol - Update to table to clarify what constitutes an SAE in line with regulatory definitions and funder AESI - Clarification on archiving responsibilities of sites and organisations involved in the study
    17 Nov 2021
    - Update to inclusion criterion 13: female participants contraception/abstinence timeframe from 150 days to 180 days - Update to female participants contraception/abstinence timeframe from 150 days to 180 days
    16 Dec 2021
    Main changes were - - Update to inclusion criterion 3: clarification on previous IO therapies patients can have received - Update to exclusion criterion 1: clarification on previous IO therapies patients can have received - Update on exclusion criterion 3: clarification to allow prior use of pembrolizumab for the CAPER study as per inclusion criterion 3 - Clarification that investigator can perform physical examinations if clinically indicated.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    28 Apr 2023
    The sponsor and CI have taken the decision to terminate the trial early due to poor recruitment and lack of funding.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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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