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    Summary
    EudraCT Number:2014-001098-15
    Sponsor's Protocol Code Number:CCRG14-001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    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 number2014-001098-15
    A.3Full title of the trial
    Adjuvant dendritic-cell immunotherapy plus temozolomide following surgery and chemoradiation in patients with newly diagnosed glioblastoma
    Adjuvante dendritische cel immuuntherapie plus temozolomide na chirurgie en chemoradiatie bij patiënten met nieuw gediagnosticeerd glioblastoom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Addition of dendritic-cell vaccination to the treatment of patients with newly diagnosed glioblastoma
    Toevoeging van dendritische cel vaccinatie aan de behandeling van patiënten met nieuw gediagnosticeerd glioblastoom
    A.3.2Name or abbreviated title of the trial where available
    ADDIT-GLIO
    A.4.1Sponsor's protocol code numberCCRG14-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02649582
    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 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 AddressDrie Eikenstraat 655
    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 (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.3.10 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
    Newly diagnosed glioblastoma (WHO grade IV) in adults, treated with surgical resection and chemoradiation
    Nieuw gediagnosticeerd glioblastoom (WHO graad IV) in volwassenen, behandeld met chirugische resectie en chemoradiatie
    E.1.1.1Medical condition in easily understood language
    Newly diagnosed glioblastoma in adults, treated with surgery and radiotherapy
    Nieuw gediagnosticeerd glioblastoom in volwassenen, behandeld met heelkunde en bestraling
    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 10018336
    E.1.2Term Glioblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the overall survival (OS) and progression-free survival (PFS) of patients with newly diagnosed glioblastoma when autologous Wilms' tumor 1 mRNA-loaded dendritic-cell vaccination is added to adjuvant temozolomide maintenance treatment following (sub)total resection and temozolomide-based chemoradiation.
    E.2.2Secondary objectives of the trial
    To evaluate the feasibility, safety, and immunogenicity of combining autologous dendritic-cell vaccination with standard adjuvant treatment of patients with newly diagnosed glioblastoma following (sub)total resection and temozolomide-based chemoradiation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Newly diagnosed, histologically verified glioblastoma (WHO grade IV)
    - Aged ≥ 18 years
    - Total or subtotal resection
    - Total resection: macroscopic complete resection as assessed by the neurosurgeon and absence of any residual contrast-enhancing mass on post-operative (≤ 72h) brain MRI
    - Subtotal resection: macroscopic complete resection as assessed by the neurosurgeon, but with residual contrast-enhancement ≤ 2 cm³ on post-operative (≤ 72h) brain MRI
    - Signed informed consent
    - Willing and able to comply with the protocol as judged by the Investigator
    - Estimated to start with chemoradiation ≥ 28 days and ≤ 49 days following surgical resection
    - Fit to undergo: leukapheresis, chemoradiation, chemotherapy and immunotherapy
    - No corticosteroid treatment ≤ 1 week before apheresis
    - WHO performance status ≤ 2
    - Life expectancy ≥ 3 months as estimated by the Investigator
    E.4Principal exclusion criteria
    - History of another malignancy, except for adequately controlled basal cell skin carcinoma, squamous skin carcinoma, or carcinoma in situ of the uterine cervix or unless the investigator rationalizes otherwise
    - Prior radiation or chemotherapy
    - Any pre-existing contraindication for temozolomide treatment
    - Any pre-existing contraindication for contrast-enhanced brain MRI
    - Pregnant or breast-feeding
    - Documented immune deficiency or systemic immune-suppressive treatment
    - Known positive viral serology for HIV, HBV, HCV, or syphilis
    - Any other condition, either physical or psychological, or reasonable suspicion thereof on clinical or special investigation, which contraindicates the use of the vaccine, or may negatively affect patient compliance, or may place the patient at higher risk of potential treatment complications
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS) and progression-free survival (PFS).
    - OS will be determined in the efficacy evaluable population and is defined as the time between surgery and death due to any cause.
    - PFS will be determined in the efficacy evaluable population and is defined as the time between surgery and the date of progression (recurrence in the case of total resection) or death due to any cause, whichever occurs first.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - A first analysis will be done when 10 patients have survived 15 months after apheresis.
    - A second analysis will be done when all patients have reached an event (death) or 15 months after apheresis.
    - A third analysis will be done at end of study. After end of study, the Sponsor has the right to update the OS and PSF data in compliance with the informed consent.

    At the time of analysis, patients without a recorded event will be censored, for OS, at the time they were last known to be alive or, for PFS, at the time of the last objective disease assessment.
    E.5.2Secondary end point(s)
    Feasibility, safety, and immunogenicity.
    - Feasibility will be assessed based on
    o Number of patients in the intention-to-treat (ITT) population that had a successful leukapheresis
    o Number of patients in the ITT population that had production of qualified (phenotypic and functional requirements) vaccines
    o Number of efficacy evaluable patients in the ITT population
    o Number of patients that had 3 weekly (± 1 day) DC vaccines administered following adjuvant chemoradiation (induction phase) and additional DC vaccination at day 21 (± 3 days) of each maintenance chemotherapy cycle (booster phase) in the ITT population

    - Safety will be assessed based on adverse event frequency (scored according to the latest version of the National Cancer Institute Common Terminology Criteria for Adverse Events) in the safety population.

    - Immunogenicity will be assessed based on ex vivo immune responses of all patients of the immunogenicity population.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Different analysis time points:
    - A first analysis will be done when 10 patients have survived 15 months after apheresis.
    - A second analysis will be done when all patients have reached an event (death) or 15 months after apheresis. Final analysis for feasibility and immunogenicity will be done at this time, safety data will be reevaluated.
    - A third analysis will be done at end of study. Final analysis for safety will be done at this time.
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 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 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 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 Opinion2014-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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