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    Clinical Trial Results:
    Progression-free Survival after Minimally Invasive Surgical Microwave Ablation (MIS-MWA) plus Durvalumab (MEDI4736) and Tremelimumab for Unresectable Non-metastatic Locally Advanced Pancreatic Cancer. MIMIPAC trial.

    Summary
    EudraCT number
    		 2018-002852-34
    Trial protocol
    		 BE  
    Global end of trial date
    29 Jan 2024

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

    Trial information

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    Trial identification
    Sponsor protocol code
    S61508
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04156087
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 AstraZeneca identifier: AZ ESR-17-12926
    Sponsors
    Sponsor organisation name
    UZLeuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Halit Topal, UZ Leuven, 0032 16346009 , halit.topal@uzleuven.be
    Scientific contact
    Halit Topal, UZ Leuven, 0032 16346009 , halit.topal@uzleuven.be
    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
    29 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jan 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Median progression-free survival time was chosen as a clinically meaningful outcome. The study aimed to detect a 2-fold increase of median PFS time compared to the historical reference, i.e. from 6 to 12 months.
    Protection of trial subjects
    Ethics review and approval, informed consent, prophylactic medication prior to infusions (to prevent chemotherapy known adverse events as per current practice and protocol recommendations), supportive care and routine monitoring.
    Background therapy
    		 Systemic chemotherapy gemcitabine will be started 6 weeks after MIS-MWA. Gemcitabine will be given at a dose of 1000 mg /m², once a week for 3 weeks, followed with a week of rest. Patients will be treated with gemcitabine and durvalumab until disease progression is observed on CT-scan measurements.
    Evidence for comparator
    		 /
    Actual start date of recruitment
    06 Jan 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    5
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient was included on 09-May-2020. Last patient last treatment visit was on 04-Aug-2024. Recruitment was stopped on 31-Oct-2022. 16 subjects have been screened; 4 were screening failures and 12 were enrolled and received at least one infusion of durvalumab and tremelimumab on study. Survival data cutoff date was 29/05/2024.

    Pre-assignment
    Screening details
    		 The study target population is represented by patients with unresectable non-metastatic locally advanced pancreatic cancer, histologically or cytologically confirmed, eligible for treatment with durvalumab, tremelimumab and gemcitabine in a first line setting and fit for MIS-MWA.

    Period 1
    Period 1 title
    Full duration = baseline to end of FU (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 MWA + D + T + Gemcitabine (SOC)
    Arm description
    		 Durvalumab and tremelimumab are the investigational drugs. Per protocol, patients receive durvalumab (MEDI4736) 1500 mg IV every four weeks in combination with tremelimumab 75 mg IV every four weeks, starting two weeks prior to MIS-MWA. Standard gemcitabine (1g/m²) is started 6 weeks after the MIS-MWA procedure and is given weekly, in four-week cycles, three administrations followed by a week of rest as background treatment. Gemcitabine is given in combination with both tremelimumab and durvalumab (MEDI4736) on weeks 6 and 10 after MIS-MWA and in combination with durvalumab only afterwards. While only four doses of tremelimumab are foreseen, treatment with durvalumab and gemcitabine is continued until disease progression is observed on CT-scan measurements or patient withdrawal for other reason.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    1428935-60-7
    Other name
    Imfinzi, MEDI4736
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All patients will receive durvalumab (1500mg Q4W) in combination with tremelimumab (75 mg IV Q4W) until confirmed disease progression unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. Standard infusion time for each is 60 minutes (±5 minutes). Tremelimumab will be administered first; the durvalumab infusion will start approximately 1 hour (maximum 2 hours) after the end of the tremelimumab infusion.

    Investigational medicinal product name
    Tremelimumab
    Investigational medicinal product code
    745013-59-6
    Other name
    MEDI1123
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All patients will receive durvalumab (1500mg Q4W) in combination with tremelimumab (75 mg IV Q4W) until confirmed disease progression unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. Standard infusion time for each is 60 minutes (±5 minutes). Tremelimumab will be administered first; the durvalumab infusion will start approximately 1 hour (maximum 2 hours) after the end of the tremelimumab infusion.

    Number of subjects in period 1
    		MWA + D + T + Gemcitabine (SOC)
    Started
    12
    Completed
    8
    Not completed
    4
         Metastasis discovered during MWA
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Full duration = baseline to end of FU
    Reporting group description
    		 All patients who consented to participate in the study and fulfilled all inclusion/exclusion criteria at baseline.

    Reporting group values
    		 Full duration = baseline to end of FU Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 7 7
    Age continuous
    Units: years
        median (full range (min-max))
    		 67.5 (34 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 8 8
    ECOG PS
    WHO EGOG performance status (PS) scale 0 Able to carry out all normal activity without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out light work 2 Ambulatory and capable of all self-care but unable to carry out any work; up and about more than 50% of waking hours. 3 Capable of only limited self-care; confined to bed or chair more than 50% of waking hours 4 Completely disabled; cannot carry on any self-care; totally confined to bed or chair
    Units: Subjects
        PS 0
    		 1 1
        PS 1
    		 11 11
        PS 2
    		 0 0
    Site of pancreatic tumour
    Units: Subjects
        Head
    		 11 11
        Body
    		 1 1
        Tail
    		 0 0
    T stage
    Units: Subjects
        T3
    		 0 0
        T4
    		 12 12
    N stage
    Units: Subjects
        N0
    		 4 4
        N1
    		 6 6
        N2
    		 2 2
    M stage at baseline
    Units: Subjects
        M0
    		 12 12
    M stage at MIS-MWA
    Intra-abdominal metastasis discovered at laparoscopy prior to MIS-MWA procedure. Patients discontinued at this timepoint.
    Units: Subjects
        M0
    		 8 8
        M1
    		 4 4
    Subject analysis sets

    Subject analysis set title
    Intent to treat set (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients who consented to participate in the study and fulfilled all inclusion/exclusion criteria at baseline.

    Subject analysis sets values
    		 Intent to treat set (ITT)
    Number of subjects
    12
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    5
        From 65-84 years
    7
    Age continuous
    Units: years
        median (full range (min-max))
    67.5 (34 to 81)
    Gender categorical
    Units: Subjects
        Female
    4
        Male
    8
    ECOG PS
    WHO EGOG performance status (PS) scale 0 Able to carry out all normal activity without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out light work 2 Ambulatory and capable of all self-care but unable to carry out any work; up and about more than 50% of waking hours. 3 Capable of only limited self-care; confined to bed or chair more than 50% of waking hours 4 Completely disabled; cannot carry on any self-care; totally confined to bed or chair
    Units: Subjects
        PS 0
    1
        PS 1
    11
        PS 2
    0
    Site of pancreatic tumour
    Units: Subjects
        Head
    11
        Body
    1
        Tail
    0
    T stage
    Units: Subjects
        T3
    0
        T4
    12
    N stage
    Units: Subjects
        N0
    4
        N1
    6
        N2
    2
    M stage at baseline
    Units: Subjects
        M0
    12
    M stage at MIS-MWA
    Intra-abdominal metastasis discovered at laparoscopy prior to MIS-MWA procedure. Patients discontinued at this timepoint.
    Units: Subjects
        M0
    8
        M1
    4

    End points

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    End points reporting groups
    Reporting group title
    MWA + D + T + Gemcitabine (SOC)
    Reporting group description
    		 Durvalumab and tremelimumab are the investigational drugs. Per protocol, patients receive durvalumab (MEDI4736) 1500 mg IV every four weeks in combination with tremelimumab 75 mg IV every four weeks, starting two weeks prior to MIS-MWA. Standard gemcitabine (1g/m²) is started 6 weeks after the MIS-MWA procedure and is given weekly, in four-week cycles, three administrations followed by a week of rest as background treatment. Gemcitabine is given in combination with both tremelimumab and durvalumab (MEDI4736) on weeks 6 and 10 after MIS-MWA and in combination with durvalumab only afterwards. While only four doses of tremelimumab are foreseen, treatment with durvalumab and gemcitabine is continued until disease progression is observed on CT-scan measurements or patient withdrawal for other reason.

    Subject analysis set title
    Intent to treat set (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients who consented to participate in the study and fulfilled all inclusion/exclusion criteria at baseline.

    Primary: Progression free survival (PFS)

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    End point title
    		 Progression free survival (PFS) [1]
    End point description
    Standard Kaplan Meier analysis, performed with IBM SPSS statistics, version 29 0.2.0. Survival data cutoff date was 29/05/2024. The study is exploratory and results are presented descriptively. No formal comparison was foreseen, this is a single arm study. The reference PFS time in patients with non-metastatic locally advanced pancreatic cancer treated with gemcitabine monotherapy is about 6 months. No conclusion can be drawn due to the insufficient sample size.
    End point type
    Primary
    End point timeframe
    From signature of informed consent to disease progression or death from any cause.
    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: Standard Kaplan Meier analysis for PFS and OS, performed with IBM SPSS statistics, version 29 0.2.0. Survival data cutoff date was 29/05/2024.The study is exploratory and results are presented descriptively. No formal comparison was foreseen, this is a single arm study. The reference PFS time in patients with non-metastatic locally advanced pancreatic cancer treated with gemcitabine monotherapy is about 6 months.No conclusion can be drawn due to the insufficient sample size.
    End point values
    		 MWA + D + T + Gemcitabine (SOC) Intent to treat set (ITT)
    Number of subjects analysed
    12
    Units: month
        median (confidence interval 95%)
    4.3 (0.0 to 15.2)
    4.3 (0.0 to 15.2)
    Attachments
    		 Untitled (Filename: MIMIPAC_PFS_cutoff 240529_chart.jpg)
    No statistical analyses for this end point

    Secondary: Safety

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    End point title
    		 Safety
    End point description
    Clinical and hematological toxicity (NCI CTCAE v. 5.0) of chemotherapy and immunotherapy. Summary tabulations and line listings of serious adverse events (14 SAE reported), non-serious adverse events, laboratory anomalies are attached. Also see section Adverse events.
    End point type
    Secondary
    End point timeframe
    From signature of informed consent to 90 days post last immunotherapy dose.
    End point values
    		 MWA + D + T + Gemcitabine (SOC) Intent to treat set (ITT)
    Number of subjects analysed
    12
    12
    Units: Occurrences
    14
    14
    Attachments
    		 Untitled (Filename: Safety A1_SAE LL.pdf)
    Untitled (Filename: Safety A2 SAE ST.pdf)
    Untitled (Filename: Safety A3 AE LL.pdf)
    Untitled (Filename: Safety A4 AE ST.pdf)
    Untitled (Filename: Safety A5 Lab ST.pdf)
    No statistical analyses for this end point

    Secondary: Post operative complications

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    End point title
    		 Post operative complications
    End point description
    The number and type of postoperative complications were recorded, i.e. fistula, hemorrhage, abscess, etc... The therapy-oriented severity grading system (TOSGS) of complications were also used and complications were allocated to surgical (SSC) and non-surgical site (NSSC) complications. Post operative complications after the MIS-MWA procedure occurred in one patient. Three occurrences were recorded as separate AEs and listed as SAE cases 9 and 10 with fatal outcome for this patient. See Safety and Adverse event sections.
    End point type
    Secondary
    End point timeframe
    From signature of informed consent to 90 days post last immunotherapy dose.
    End point values
    		 MWA + D + T + Gemcitabine (SOC) Intent to treat set (ITT)
    Number of subjects analysed
    12
    12
    Units: Occurrences
    3
    3
    No statistical analyses for this end point

    Secondary: Length of hospital stay

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    End point title
    		 Length of hospital stay
    End point description
    Postoperative length of hospital stay (after MIS-MWA)
    End point type
    Secondary
    End point timeframe
    From signature of informed consent to 90 days post last immunotherapy dose.
    End point values
    		 MWA + D + T + Gemcitabine (SOC) Intent to treat set (ITT)
    Number of subjects analysed
    12
    12
    Units: day
        median (full range (min-max))
    2 (2 to 17)
    2 (2 to 17)
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    Tertiary endpoint. Standard Kaplan Meier analysis, performed with IBM SPSS statistics, version 29 0.2.0.
    End point type
    Secondary
    End point timeframe
    From signature of informed consent to death of any cause or date of last contact for patients still alive.
    End point values
    		 MWA + D + T + Gemcitabine (SOC) Intent to treat set (ITT)
    Number of subjects analysed
    12
    12
    Units: month
        median (confidence interval 95%)
    14.9 (9.4 to 20.4)
    14.9 (9.4 to 20.4)
    Attachments
    		 Untitled (Filename: MIMIPAC_OS_cutoff 240529_chart.jpg)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signature of ICF to 90 days post last dose of immunotherapy (mandatory safety FU)
    Adverse event reporting additional description
    Only grade 3/4/5 of non serious adverse events are reported. All events including grade 1/2 are available in line listings attached.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    Total (safety set)
    Reporting group description
    		 -

    Serious adverse events
    		 Total (safety set)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 12 (58.33%)
         number of deaths (all causes)
    11
         number of deaths resulting from adverse events
    1
    Investigations
    Liver enzymes increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Postoperative hemorrhage
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Total (safety set)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 12 (100.00%)
    Investigations
    Hemoglobin decreased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    White blood cell count decreased
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Absolute neutrophil count decreased
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    3
    ALP increased
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    ALT increased
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    AST increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    GGT increased
         subjects affected / exposed
    5 / 12 (41.67%)
         occurrences all number
    5
    Total bilirubine increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Amylase increased
         subjects affected / exposed
    4 / 12 (33.33%)
         occurrences all number
    4
    Lipase increased
         subjects affected / exposed
    4 / 12 (33.33%)
         occurrences all number
    4
    Hyperglycaemia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Ascites
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Diarrhea
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Renal and urinary disorders
    Cystocoele
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Generalized muscle weakness
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Infections and infestations
    Absolute lymphocyte count decreased
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hyperglycemia
         subjects affected / exposed
    1 / 12 (8.33%)
         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
    19 Mar 2020
    Substantial amendment 1 – ICF V1.2 dd 19Feb2020
    14 Jan 2021
    Substantial amendment 2 – protocol V9 dd 10 Nov 2020 and ICF V1.3 dd 13 Jan 2021
    24 Aug 2021
    Substantial amendment 3 - protocol V10 dd 20 Jul 2021 and ICF V2 dd 20 Jul 2021
    24 May 2023
    Substantial amendment 4 - protocol V11 dd 17 Apr 2023 and ICF V3 dd 17 Apr 2023

    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.
    Insufficient sample size due to low accrual. Non randomised design for an efficacy endpoint

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25524417
    http://www.ncbi.nlm.nih.gov/pubmed/24907635
    http://www.ncbi.nlm.nih.gov/pubmed/22658128
    http://www.ncbi.nlm.nih.gov/pubmed/24070507
    http://www.ncbi.nlm.nih.gov/pubmed/15173017
    http://www.ncbi.nlm.nih.gov/pubmed/32664183
    http://www.ncbi.nlm.nih.gov/pubmed/31318392
    http://www.ncbi.nlm.nih.gov/pubmed/31996388
    http://www.ncbi.nlm.nih.gov/pubmed/33442411
    http://www.ncbi.nlm.nih.gov/pubmed/30578687
    http://www.ncbi.nlm.nih.gov/pubmed/32816849
    http://www.ncbi.nlm.nih.gov/pubmed/31676670
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