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    Summary
    EudraCT Number:2014-001099-75
    Sponsor's Protocol Code Number:CCRG13-002
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2015-07-23
    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 number2014-001099-75
    A.3Full title of the trial
    First-line immunotherapy using Wilms’ tumor protein 1 (WT1)-targeted dendritic cell vaccinations for malignant pleural mesothelioma.
    Eerstelijns immuuntherapie met Wilms’ tumor 1 (WT1)-geladen dendritische celvaccinaties voor maligne pleuraal mesothelioom.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dendritic cell-based immunotherapy targeting the tumor protein WT1 to treat patients with malignant pleural mesothelioma.
    A.3.2Name or abbreviated title of the trial where available
    MPM-MESODEC
    A.4.1Sponsor's protocol code numberCCRG13-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02649829
    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 SponsorAntwerp University Hospital
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportStichting Tegen Kanker
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportKom op tegen Kanker
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAntwerp University Hospital
    B.5.2Functional name of contact pointEva Lion
    B.5.3 Address:
    B.5.3.1Street AddressWilrijkstraat 10
    B.5.3.2Town/ cityEdegem
    B.5.3.3Post codeB-2650
    B.5.3.4CountryBelgium
    B.5.4Telephone number003238214112
    B.5.5Fax number003238214456
    B.5.6E-maileva.lion@uantwerpen.be
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCryopreserved Wilms' tumor 1 (WT1) mRNA-electroporated dendritic cells
    D.3.2Product code WT1 mRNA-EP DC
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNWilms' tumor 1 (WT1) mRNA-electroporated dendritic cell vaccine
    D.3.9.2Current sponsor codeWT1 mRNA-EP DC
    D.3.9.3Other descriptive nameCELL SUSPENSION CONTAINING DENDRITIC CELLS
    D.3.9.4EV Substance CodeSUB120526
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number8.10e6 to 10.10e6
    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) Yes
    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
    Treatment-naïve malignant pleural mesothelioma patients (eligible for standard chemotherapy and, in case of resectable disease, surgery)
    Nieuw gediagnosticeerd maligne pleuraal mesothelioompatiënten (in aanmerking voor standaard chemotherapie en, indien reseceerbare ziekte, chirurgie).
    E.1.1.1Medical condition in easily understood language
    Newly diagnosed malignant pleural mesothelioma patients without previous cancer therapy (eligible for standard chemotherapy and, in case of operable disease, surgery)
    Nieuw gediagnosticeerd maligne pleuraal mesothelioompatiënten zonder voorgaande kankerbehandeling (in aanmerking voor standaard chemotherapie en, indien operabele ziekte, chirurgie).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046859
    E.1.2Term Vaccination
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10059518
    E.1.2Term Pleural 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
    To evaluate the feasibility and safety of Wilms' tumor 1 mRNA-electroporated dendritic cell (DC) vaccinations in patients with malignant pleural mesothelioma (MPM) as first-line treatment combined with standard chemotherapy
    E.2.2Secondary objectives of the trial
    Clinical objective - To assess the time to progression (TTP) and progression-free survival (PFS) after chemoimmunotherapy with or without pleurectomy/decortication (P/D) and to assess overall survival (OS) from diagnosis and start of treatment.

    Translational objective - To determine the in vivo systemic and local immunogenicity of WT1-targeted DC vaccination when combined with chemotherapy as treatment of MPM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis with histologically proven epithelial MPM.
    - Age: ≥18 years at the time of enrollment.
    - WHO performance status 0–1 at the time of enrollment.
    - Fit to undergo general anesthesia, a thoracoscopy, leukapheresis, chemotherapy, immunotherapy and (in case of resectable disease) P/D.
    - No history of receiving any investigational treatment within 28 days of study enrollment.
    - No history of intolerance to pemetrexed and/or cisplatin.
    - Before patient registration written informed consent must be given according to ICH/GCP, and national/local regulations.
    E.4Principal exclusion criteria
    - Unwilling or unable to comply with the study requirements.
    - Prior treatment for mesothelioma.
    - History of other malignancy within the last five years, except for non-melanoma skin cancer and cervical carcinoma in situ or unless the investigator rationalizes otherwise.
    - Known proven metastases.
    - Known concomitant presence of any immunosuppressive disease (e.g. HIV) or any active autoimmune condition, except for vitiligo.
    - Pregnant or breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    Feasibility and safety of WT1-targeted DC vaccination will be evaluated in MPM patients that undergo standard chemotherapy and, in case of resectable disease, pleurectomy/decortication.

    Safety will be assessed by clinical laboratory tests and adverse event reporting.
    - Microbiological testing (bacteria, fungi, mycoplasma, endotoxin) will be performed to assess safe DC vaccine production.
    - Local toxicity (e.g. skin reactions at injection site) will be reported.
    - Systemic toxicity will be scored according to the latest version of the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) and Common Toxicity Criteria (CTC).

    Feasibility will be assessed based on the success of (1) leukapheresis and (2) DC vaccine preparation (production of at least 4 DC vaccines) and (3) administration of combined chemoimmunotherapy cycles within the proposed time schedule.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analyses will be performed on all evaluable patients. Patients are considered evaluable if they received at least one DC vaccine. Both patient and tumor evaluation will be performed at regular visits.
    E.5.2Secondary end point(s)
    - Clinical endpoints: time to progression (TTP), progression-free survival (PFS) and overal survival (OS).

    Tumor assessment will be performed according to the latest modified Response Evaluation Criteria In Solid Tumors (RECIST), PET Response Criteria In Solid Tumors (PERCIST) and endpoints for cancer immunotherapy trials.

    - Translational endpoint: immunological responses.

    Systemic and local immunological response analysis will be performed to determine the in vivo immunogenicity of WT1 mRNA-electroporated DC vaccinations when combined with chemotherapy for the frontline treatment of MPM by evaluating the development of effective anti-mesothelioma immunity.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinical endpoints - Clinical response analysis will be performed on all evaluable patients for disease progression and survival: (i) TTP and PFS after chemoimmunotherapy, (ii) OS from diagnosis and start of treatment. Patient follow-up is until 90 days after final DC vaccine administration or 22 months after diagnosis, whichever occurs later.

    Translational endpoints - Blood immunomonitoring studies will be performed prior to vaccination (baseline), after immunotherapy and following disease progression. Patients will undergo blood sample collection before leukapheresis, after the fourth vaccine and at three time points following disease progression. Tumor biopsies and surgical specimens (in case of operabel MPM) will be used for local immunological response assessment.

    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    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 No
    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 years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    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)
    Normal treatment and follow-up
    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 Decision2015-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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