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    Summary
    EudraCT Number:2017-001774-41
    Sponsor's Protocol Code Number:MM04
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-10-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-001774-41
    A.3Full title of the trial
    A Randomized, Open-Label Phase II/III Study With Dendritic Cells Loaded With Allogeneic Tumour Cell Lysate (PheraLys) in Subjects With Mesothelioma as Maintenance Treatment (MesoPher) After Chemotherapy.

    DENIM (DENdritic Cell Immunotherapy for Mesothelioma)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on dendritic cell therapy as maintenance therapy for patients that have been treated for Mesothelioma.
    A.3.2Name or abbreviated title of the trial where available
    DENIM (DENdritic Cell Immunotherapy for Mesothelioma)
    A.4.1Sponsor's protocol code numberMM04
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmphera B.V.
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Union
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportErasmus MC
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportAmphera B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmphera B.V.
    B.5.2Functional name of contact pointIlona Enninga
    B.5.3 Address:
    B.5.3.1Street AddressOnderwijs boulevard 225
    B.5.3.2Town/ city 's Hertogenbosch
    B.5.3.3Post code5223 DE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31736274520
    B.5.6E-mailIlona.Enninga@amphera.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1229
    D.3 Description of the IMP
    D.3.1Product nameMesoPher
    D.3.4Pharmaceutical form Dispersion for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMesoPher
    D.3.9.2Current sponsor codeMesoPher
    D.3.9.3Other descriptive nameMESOPHER
    D.3.9.4EV Substance CodeSUB188358
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pleural malignant mesothelioma.
    E.1.1.1Medical condition in easily understood language
    Malignant mesothelioma, cancer of the lung pleura.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10027407
    E.1.2Term Mesothelioma malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the overall survival rate (determined from the time of randomization in the study) of subjects who receive dendritic cell immunotherapy with MesoPher plus best supportive care (BSC) compared to BSC alone.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    • to evaluate the overall survival rate at 12 and 18 months after randomization, in subjects who receive dendritic cell immunotherapy with MesoPher plus BSC compared to BSC alone.
    • to evaluate progression free survival in subjects who receive dendritic cell immunotherapy with MesoPher plus BSC compared to BSC alone.
    • to evaluate the overall response rate and duration of response in subjects who receive dendritic cell immunotherapy with MesoPher plus BSC compared to BSC alone.
    • to evaluate quality of life in subjects who receive dendritic cell immunotherapy with MesoPher plus BSC compared to BSC alone.
    • to evaluate the safety and tolerability of dendritic cell immunotherapy with MesoPher.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects will be enrolled in this study only if they meet all of the following criteria:
    1. Signed informed consent form (ICF) indicating an understanding of the purposes, risks, and procedures required for the study and willingness and ability to participate in the study.
    2. Subjects with a histologically confirmed diagnosis of pleural malignant mesothelioma, who are non-progressive (so CR, PR or SD) after 4 to 6 cycles with first line chemotherapy with antifolate/platinum (as determined by CT scanning).
    • Subjects retreated with antifolate/platinum after a disease-free interval of 12 months after the first chemotherapeutic treatment are eligible. Disease free interval is defined as the time between the administration of the last chemotherapy cycle and the date of disease progression.
    • Concurrent bevacizumab during chemotherapy is allowed, but patients who receive bevacizumab will only be eligible if they stop bevacizumab due to non-tolerance before or by the end of the chemotherapy period. Patients who benefit from bevacizumab use may continue treatment with bevacizumab and will consequently not be eligible for the study.
    3. Subject must have signed informed consent within 8 weeks of their last chemo and the date of their informed consent must be such that all per protocol required procedures can be done in such a timeframe that the first treatment can be given within 9 and 13 weeks after their last chemotherapy.
    4. Measurable disease has to be assessed by modified RECIST criteria on CT scanning by radiologic imaging. Even in the absence of measurable disease patients can be included in the study. In such case CT scanning will also be done to evaluate the disease.
    5. Subjects must be at least 18 years old.
    6. Subjects must have WHO-ECOG performance status of 0 or 1.
    7. Subjects must have adequate organ function and adequate bone marrow reserve at screening:
    - creatinine ≤ 1.5 × upper limit of normal [ULN] or estimated glomerular filtration rate ≥ 50mL/min
    - ALT, AST, bilirubin ≤ 1.5 × ULN
    - Absolute neutrophil count ≥1.5 x 1000000000/L, platelet count ≥100 x 1000000000/L, and Hb ≥9.0g/dL.
    NOTE: borderline isolated result in any of the above parameters may be acceptable subject to review and discussion between the Investigator and Medical monitor.
    8. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test just prior to the first study treatment administration on Day 1, and must be willing to use an effective contraceptive method (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) or true abstinence (when this is in line with the preferred and usual lifestyle)* during the study and for at least 12 months after the last study treatment administration. *True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    9. Men must be willing to use an effective contraceptive method (eg, condom, vasectomy) during the study and for at least 12 months after the last study treatment administration.
    10. Subjects must be willing and able to follow the protocol requirements and must be willing and able to return to the study center for adequate follow-up visits.
    E.4Principal exclusion criteria
    Subjects will not be enrolled in this study if they meet any of the following criteria:
    1. Subject with any concurrent medical, psychological or psychiatric disease or condition that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study.
    2. Subject with any serious intercurrent chronic or acute illness such as cardiac (New York Heart Association [NYHA] Class III or IV) or hepatic disease or other serious concomitant disease considered by the investigator to constitute an unwarranted high risk for investigational dendritic cell treatment.
    3. Subject with any known active serious infection, including human immunodeficiency virus (HIV), hepatitis B or C virus or syphilis infection.
    4. Subject with a history of autoimmune disease, except for diabetes mellitus type I or other conditions, where patient can be eligible following discussion with medical monitor.
    5. Subject who has received an organ allograft.
    6. Subject with any previous malignancy except adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the subject has been disease-free for at least 3 years.
    7. Subject with a known allergy to shell fish (may contain KLH).
    8. Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use effective contraceptive methods (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) during the study and for at least 12 months after the last study treatment administration.
    9. Subject with inadequate peripheral vein access to perform leukapheresis.
    10. Use of >10 mg of prednisolone or equivalent/day and/or other immunosuppressive agents during the 6 weeks before the first study treatment anticipated D1 date and throughout the study. Prophylactic usage of dexamethasone during chemotherapy is excluded from this 6-week interval. Inhaled or topical steroids, and adrenal replacement steroid </=10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
    11. Patient treated with colony stimulating factors (e.g. G-CSF) in the 14 days of screening and in the period between screening and date of leukapheresis.
    12. Treatment with any investigational product within 4 weeks or 5 half-lives (whichever is longer) before the first study treatment administration or concomitant participation in another clinical study. Simultaneous participation in another study may be permitted, but prior written permission by the medical monitor is required.
    13. Subject who is unwilling or unable to follow the protocol requirements, including availability for follow-up assessment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study will be overall survival (OS). Overall survival will be determined as the time from randomization (about 3 to 4 months after diagnosis) until death. For subjects who are alive at the end of the study or lost to follow-up, OS will be censored on the last date when subjects are known to be alive.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study.
    Death.
    E.5.2Secondary end point(s)
    The following efficacy endpoints are considered secondary:
    • Survival status at 12, and 18 months after randomization.
    • Progression-free survival (PFS), including symptomatic (clear evident signs of disease progression) progression-free survival. Progression free survival (PFS) will be determined by the local investigators from CT scans, using the modified RECIST criteria. The time of the first CT scan showing progression (i.e., time to progression) will define the end of the PFS.
    • Overall response rate and duration of response. Overall response rate is defined as the proportion of subjects with confirmed CR or PR according to the modified RECIST criteria (i.e. CR or PR that persist on repeat imaging performed >4 weeks after the initial documentation of response). Response to treatment will be determined at every CT scan.
    • The change in Quality of Life from baseline. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and its lung cancer (LC)-specific module EORTC QLQ - LC13 will be used to evaluate quality of life.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 and 18 months after randomisation
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Best Supportive Care
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 230
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Best supportive care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-24
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