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    Clinical Trial Results:
    Phase ΙΙ (window) preoperative study of olaparib with cisplatin or with durvalumab (MEDI4736) or alone or no treatment in patients with histologically proven squamous cell carcinoma of the head and neck who are candidates for surgery

    Summary
    EudraCT number
    		 2015-005268-41
    Trial protocol
    		 GR  
    Global end of trial date
    10 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jun 2021
    First version publication date
    03 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HE5A/15
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02882308
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hellenic Cooperative Oncology Group
    Sponsor organisation address
    18 Hatzikonstandi, Athens, Greece, 11524
    Public contact
    Clincal Trials, Hellenic Cooperative Oncology Group, 0030 2106912520, hecogoff@otenet.gr
    Scientific contact
    Clincal Trials, Hellenic Cooperative Oncology Group, 0030 2106912520, hecogoff@otenet.gr
    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
    16 Nov 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the difference in change in the tumour Ki-67 before and after treatment with the combination of olaparib + cisplatin or olaparib monotherapy.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles of the Declaration of Helsinki, the Good Clinical Practice guidelines and the local regulatory requirements
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Oct 2016
    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
    Greece: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    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)
    23
    From 65 to 84 years
    15
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled in the study from 20 October 2016 until 10 October 2019 in 3 sites

    Pre-assignment
    Screening details
    		 Patients were screened for eligibility before entering the study and signed the informed consent form which was obtained before any study procedure

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cisplatin / Olaparib
    Arm description
    		 cisplatin 60 mg/m2 day1 followed by olaparib tabl 75mg daily for 5 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    olaparib tabl 75mg daily for 5

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    One cycle of combined treatment with cisplatin 60 mg/m2 day 1. Cisplatin infusion was administered according to the local treatment guidelines with adequate pre- and post-hydration and antiemetic treatment.

    Arm title
    		 Olaparib only
    Arm description
    		 Olaparib tabl 600mg daily for 21-28 days depending on the day of surgery. When surgery was delayed, olaparib was continued until the day before surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One cycle of olaparib tabl monotherapy 600 mg daily (2 tabl 150 mg morning – 2 tabl 150 mg the evening) day1-day21. No routine prophylactic anti-emetic treatment is required at the start of study treatment. If surgery is delayed, olaparib will be continued until the day before surgery

    Arm title
    		 No treatment
    Arm description
    		 No treatment was administered until the date of surgery or 2nd biopsy
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Durvalumab/Olaparib
    Arm description
    		 Durvalumab 1500 mg day1 followed by olaparib tabl 600mg daily for 21-28 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Olaparib tabl 600mg daily (2 tabl 150 mg morning – 2 tabl 150 mg evening) day1-day21. Olaparib treatment was started immediately after the completion of durvalumab infusion.

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    One cycle of combined treatment with durvalumab 1500mg day1. The durvalumab solution should not be infused through an IV line in which other solutions or medications were being administered.

    Number of subjects in period 1
    		Cisplatin / Olaparib Olaparib only No treatment Durvalumab/Olaparib
    Started
    12
    12
    5
    12
    Completed
    12
    10
    5
    9
    Not completed
    0
    2
    0
    3
         Disease progression
    -
    -
    -
    1
         Adverse event, non-fatal
    -
    -
    -
    1
         Patient did not present for follow-up
    -
    -
    -
    1
         Protocol deviation
    -
    2
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cisplatin / Olaparib
    Reporting group description
    		 cisplatin 60 mg/m2 day1 followed by olaparib tabl 75mg daily for 5 days

    Reporting group title
    Olaparib only
    Reporting group description
    		 Olaparib tabl 600mg daily for 21-28 days depending on the day of surgery. When surgery was delayed, olaparib was continued until the day before surgery.

    Reporting group title
    No treatment
    Reporting group description
    		 No treatment was administered until the date of surgery or 2nd biopsy

    Reporting group title
    Durvalumab/Olaparib
    Reporting group description
    		 Durvalumab 1500 mg day1 followed by olaparib tabl 600mg daily for 21-28 days

    Reporting group values
    		 Cisplatin / Olaparib Olaparib only No treatment Durvalumab/Olaparib Total
    Number of subjects
    		 12 12 5 12 41
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 64.7 (51.7 to 70.5) 61.3 (47.8 to 84.8) 56.3 (54 to 67) 68.7 (48.6 to 85.9) -
    Gender categorical
    Units: Subjects
        Female
    		 1 3 1 3 8
        Male
    		 11 9 4 9 33
    Subject analysis sets

    Subject analysis set title
    Eligible patients
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subgroup of patients that satisfied the entry criteria of the trial. Two patients were excluded.

    Subject analysis sets values
    		 Eligible patients
    Number of subjects
    39
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    61.5 (47.8 to 85.9)
    Gender categorical
    Units: Subjects
        Female
    8
        Male
    31

    End points

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    End points reporting groups
    Reporting group title
    Cisplatin / Olaparib
    Reporting group description
    		 cisplatin 60 mg/m2 day1 followed by olaparib tabl 75mg daily for 5 days

    Reporting group title
    Olaparib only
    Reporting group description
    		 Olaparib tabl 600mg daily for 21-28 days depending on the day of surgery. When surgery was delayed, olaparib was continued until the day before surgery.

    Reporting group title
    No treatment
    Reporting group description
    		 No treatment was administered until the date of surgery or 2nd biopsy

    Reporting group title
    Durvalumab/Olaparib
    Reporting group description
    		 Durvalumab 1500 mg day1 followed by olaparib tabl 600mg daily for 21-28 days

    Subject analysis set title
    Eligible patients
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subgroup of patients that satisfied the entry criteria of the trial. Two patients were excluded.

    Primary: Change in the tumour Ki-67

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    End point title
    		 Change in the tumour Ki-67 [1]
    End point description
    To investigate the change in the tumour Ki-67 after treatment (ΔKi67) with the combination of olaparib + durvalumab or olaparib + cisplatin or olaparib monotherapy.
    End point type
    Primary
    End point timeframe
    At baseline and at the day of the surgery or 2nd biopsy (at days 23-29 days).
    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: Since the primary endpoint of the study was the assessment of the percentage of patients with ΔKi67>=25%, we have provided the corresponding statistics for each treatment group separately. The study was not designed to be comparative and therefore no statistical comparisons were performed among treatment/study groups.
    End point values
    		 Cisplatin / Olaparib Olaparib only No treatment Durvalumab/Olaparib
    Number of subjects analysed
    12
    9 [2]
    4 [3]
    8 [4]
    Units: percentage of patients with ΔKi67>=25%
        number (not applicable)
    33.3
    77.8
    25
    25
    Notes
    [2] - 9 eligible patients with paired data pre and post treatment with olaparib
    [3] - 4 patients with paired data before and after second surgery/biopsy.
    [4] - 8 eligible patients with paired data pre- and post treatment with olaparib and durvalumab.
    No statistical analyses for this end point

    Secondary: pCRR - Pathologic complete response rate

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    End point title
    		 pCRR - Pathologic complete response rate [5]
    End point description
    pCRR is defined as the percentage of patients achieving complete disappearance of tumour cells in the primary tumour and regional lymph nodes. Therefore, pCRR can be assessed only in patients who will undergo surgery.
    End point type
    Secondary
    End point timeframe
    On week 4 only for operable patients
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: We have provided the percentage of patients with pCR in the groups of patients who received treatment with olaparib.
    End point values
    		 Cisplatin / Olaparib Olaparib only Durvalumab/Olaparib
    Number of subjects analysed
    12
    10 [6]
    12
    Units: percentage of patients
        number (not applicable)
    8.3
    0
    8.3
    Notes
    [6] - Eligible patients treated with olaparib monotherapy
    No statistical analyses for this end point

    Secondary: ORR - Overall Response Rate

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    End point title
    		 ORR - Overall Response Rate [7]
    End point description
    To assess the objective response rate (ORR) defined as the percentage of patients achieving a complete or partial response as the best response according to RECIST 1.1 criteria.
    End point type
    Secondary
    End point timeframe
    Imaging studies were performed at baseline and on week 4
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: We have provided statistics for the percentage of patients with an objective tumor response for all three groups of patients treated with olaparib but not for the control group.
    End point values
    		 Cisplatin / Olaparib Olaparib only Durvalumab/Olaparib
    Number of subjects analysed
    12
    9 [8]
    12
    Units: percentage of patients
    number (not applicable)
        ORR
    8.3
    11.1
    16.7
    Notes
    [8] - Eligible patients evaluable for response
    No statistical analyses for this end point

    Secondary: Tolerability of treatment

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    End point title
    		 Tolerability of treatment [9]
    End point description
    To assess the tolerability of treatment
    End point type
    Secondary
    End point timeframe
    From the 1st day of therapy and every week for 4 weeks maximum and 90 days after last therapy administration
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: We have provided statistics for eligible patients who received at least one dose of the study drug (s). Therefore, statistics have been provided for all three groups of patients treated with olaparib but not for the control group.
    End point values
    		 Cisplatin / Olaparib Olaparib only Durvalumab/Olaparib
    Number of subjects analysed
    12
    10 [10]
    12
    Units: number of patients
        Any adverse event
    11
    10
    9
        Fatal adverse events
    0
    0
    0
        Serious adverse events
    1
    0
    1
    Notes
    [10] - Eligible patients who received at least one dose of the study drug.
    No statistical analyses for this end point

    Other pre-specified: Mutations in genes associated with DNA repair

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    End point title
    		 Mutations in genes associated with DNA repair
    End point description
    End point type
    Other pre-specified
    End point timeframe
    At baseline, on day of surgery or the 2nd biopsy (at days 23-29)
    End point values
    		 Cisplatin / Olaparib Olaparib only No treatment Durvalumab/Olaparib
    Number of subjects analysed
    12
    10 [11]
    5
    12
    Units: number of patients
        Mutations in DDR pre-treatment
    3
    1
    1
    0
        Mutations in DDR post-treatment
    1
    0
    0
    0
    Notes
    [11] - Eligible patients
    No statistical analyses for this end point

    Other pre-specified: CTCs-circulating tumor cells

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    End point title
    		 CTCs-circulating tumor cells [12]
    End point description
    To identify circulating tumor cells (CTCs) evaluated for DNA repair biomarkers and PD-L1
    End point type
    Other pre-specified
    End point timeframe
    At baseline, a day before surgery and 90 days after surgery
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: PDL-1 CTCs were only assessed in the group of patients treated with olaparib and durvalumab.
    End point values
    		 Durvalumab/Olaparib
    Number of subjects analysed
    6 [13]
    Units: number of patients
        Increase in PDL-1 after treatment
    2
        Decrease in PDL-1 after treatment
    3
        No change in PDL-1 after treatment
    1
    Notes
    [13] - Patients with paired data before and after treatment with olaparib and durvalumab.
    No statistical analyses for this end point

    Other pre-specified: Immunohistochemistry (IHC) analysis

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    End point title
    		 Immunohistochemistry (IHC) analysis
    End point description
    Immunohistochemistry (IHC) analysis of STING activation and immune response
    End point type
    Other pre-specified
    End point timeframe
    At baseline and at the day of the surgery or 2nd biopsy (at days 23-29 days)
    End point values
    		 Cisplatin / Olaparib Olaparib only No treatment Durvalumab/Olaparib
    Number of subjects analysed
    12 [14]
    9 [15]
    4 [16]
    7 [17]
    Units: number of patients
        Increase in STING levels post treatment/surgery
    2
    3
    1
    0
        Decrease in STING levels post treatment/surgery
    6
    4
    3
    4
        No change in STING levels post treatment/surgery
    4
    2
    0
    3
    Notes
    [14] - Eligible patients with paired data at both timepoints (pre- and post- treatment/ surgery/biopsy.
    [15] - Eligible patients with paired data at both timepoints (pre- and post- treatment/ surgery/biopsy.
    [16] - Patients with paired data at both timepoints (pre- and post- treatment/ surgery/biopsy.
    [17] - Eligible patients with paired data at both timepoints (pre- and post- treatment/ surgery/biopsy.
    No statistical analyses for this end point

    Other pre-specified: RNA-sequencing in fresh tumor samples

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    End point title
    		 RNA-sequencing in fresh tumor samples
    End point description
    RNA-sequencing in fresh tumor samples of the study population
    End point type
    Other pre-specified
    End point timeframe
    At baseline and at the day of the surgery or 2nd biopsy (at days 23-29 days)
    End point values
    		 Cisplatin / Olaparib Olaparib only No treatment Durvalumab/Olaparib
    Number of subjects analysed
    11 [18]
    9 [19]
    3 [20]
    8 [21]
    Units: number of patients
        Increase in PDL-1 mRNA post treatment/surgery
    5
    4
    2
    7
        Decrease in PDL-1 mRNA post treatment/surgery
    6
    5
    1
    1
        No change in PDL-1 mRNA post treatment/surgery
    0
    0
    0
    0
        Increase in PDL-2 mRNA post treatment/surgery
    7
    4
    2
    7
        Decrease in PDL-2 mRNA post treatment/surgery
    4
    5
    1
    1
        No change in PDL-2 mRNA post treatment/surgery
    0
    0
    0
    0
        Increase in CD8A mRNA post treatment/surgery
    9
    7
    1
    6
        Decrease in CD8A mRNA post treatment/surgery
    2
    2
    2
    2
        No change in CD8A post treatment/surgery
    0
    0
    0
    0
        Increase in IRF mRNA post treatment/surgery
    3
    3
    1
    2
        Decrease in IRF mRNA post treatment/surgery
    8
    6
    2
    6
        No change in IRF mRNA post treatment/surgery
    0
    0
    0
    0
    Notes
    [18] - Eligible patients with paired data at both timepoints (pre- and post-treatment/surgery/biopsy).
    [19] - Eligible patients with paired data at both timepoints (pre- and post-treatment/surgery/biopsy).
    [20] - Patients with paired data at both timepoints (pre- and post-treatment/surgery/biopsy).
    [21] - Eligible patients with paired data at both timepoints (pre- and post-treatment/surgery/biopsy).
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the 1st day of therapy and every week for 4 weeks maximum and 90 days after last therapy administration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Olaparib - Cisplatin
    Reporting group description
    		 -

    Reporting group title
    Olaparib monotherapy
    Reporting group description
    		 -

    Reporting group title
    Olaparib - durvalumab
    Reporting group description
    		 -

    Reporting group title
    No treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Olaparib - Cisplatin Olaparib monotherapy Olaparib - durvalumab No treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 5 (20.00%)
         number of deaths (all causes)
    8
    6
    2
    2
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Post – operative haemorrhage
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Thromboembolic event
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Colonic haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Olaparib - Cisplatin Olaparib monotherapy Olaparib - durvalumab No treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 12 (91.67%)
    11 / 12 (91.67%)
    9 / 12 (75.00%)
    2 / 5 (40.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Carotid artery thrombosis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    General disorders and administration site conditions
    Edema face
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    1
    Fatigue
         subjects affected / exposed
    2 / 12 (16.67%)
    3 / 12 (25.00%)
    1 / 12 (8.33%)
    0 / 5 (0.00%)
         occurrences all number
    2
    3
    1
    0
    Localised oedema
    Additional description: Localised oedema in lips
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood creatine increased
         subjects affected / exposed
    3 / 12 (25.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    3
    1
    0
    0
    INR increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    Total protein low
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    4 / 12 (33.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    4
    1
    0
    0
    Platelet count decreased
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Weight gain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Weight loss
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    4 / 12 (33.33%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    4
    2
    0
    0
    Injury, poisoning and procedural complications
    Post - operative pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Somnolence
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 12 (16.67%)
    7 / 12 (58.33%)
    2 / 12 (16.67%)
    1 / 5 (20.00%)
         occurrences all number
    2
    7
    2
    1
    Leukocytosis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dysphagia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tongue ulceration
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Oral haemorrhage
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oral pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Hepatobiliary disorders
    Urea increased
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypercalcaemia
         subjects affected / exposed
    3 / 12 (25.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    2 / 12 (16.67%)
    3 / 12 (25.00%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    5
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    LDH increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Sep 2017
    changes in ICF v1.2, SUPPLEMENTARY ICF v1.O. New IB for OLAPARIB v14. New Site.
    01 Nov 2018
    changes in PROTOCOL v1.2, ICF MAIN v1.3, ICF BIOSAMPLE v1.1, ICF PRGNANCY v1.2. New IB of DURVALUMAB v11. INCREASE IN THE NUMBER OF PARTICIPANTS FROM 39 TO 41. EXTENTION OF DURATION FROM 1 YEAR & 3 MONTHS TO 2 YEARS & 7 MONTHS.
    27 Feb 2019
    New IB for Durvalumab v13. Extention of duration of Clinical Trial from 2 years & 7 months to 3 years & 1 month
    10 Apr 2019
    Changes in ICF Main v1.4. New IB for Olaparib v16

    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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