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    Summary
    EudraCT Number:2017-000304-14
    Sponsor's Protocol Code Number:GlioVax
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-02-17
    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 ConcernedGermany - PEI
    A.2EudraCT number2017-000304-14
    A.3Full title of the trial
    Phase II trial of vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy in newly diagnosed glioblastoma

    Phase II Studie zur Vakzinierung mit lysat-beladenen, reifen Dendritischen Zellen integriert in die Standard-Radiochemotherapie beim neudiagnostizierten Glioblastom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial on efficacy and safety of vaccination of newly diagnosed glioblastoma patients with the patient’s own immune cells.
    Studie zur Wirksamkeit und Sicherheit einer Impfung mit körpereigenen Abwehrzellen bei Patienten mit neudiagnostiziertem Glioblastom
    A.3.2Name or abbreviated title of the trial where available
    GlioVax
    GlioVax
    A.4.1Sponsor's protocol code numberGlioVax
    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 SponsorHeinrich-Heine-University Düsseldorf
    B.1.3.4CountryGermany
    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 supportBundesministerium für Bildung und Forschung (BMBF)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Center Düsseldorf
    B.5.2Functional name of contact pointDepartment of Neurosurgery
    B.5.3 Address:
    B.5.3.1Street AddressMoorenstraße 5
    B.5.3.2Town/ cityDüsseldorf
    B.5.3.3Post code40225
    B.5.3.4CountryGermany
    B.5.4Telephone number00492118116276
    B.5.5Fax number00492118104658
    B.5.6E-mailMichael.Sabel@med.uni-duesseldorf.de
    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 namedendritic cell vaccine
    D.3.2Product code GlioVax
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.11 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
    newly diagnosed glioblastoma
    neudiagnostiziertes Glioblastom
    E.1.1.1Medical condition in easily understood language
    newly diagnosed brain tumor
    neudiagnostizierter Hirntumor
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 the study is to determine whether overall survival of newly diagnosed GBM patients treated with lysate-loaded, mature dendritic cell vaccines as add-on to the standard of care consisting of resection, radiotherapy with concomitant temozolomide chemotherapy and subsequent adjuvant temozolomide chemotherapy is superior to the treatment with the standard of care alone
    Das primäre Studienziel ist zu prüfen, ob die zusätzliche Vakzinierung mit Tumorlysat-beladenen, reifen Dendritischen Zellen das Überleben (Overall Survival, OS) von Patienten mit neudiagnostiziertem Glioblastom verbessert, die mit der gegenwärtigen Standardtherapie aus Radiochemotherapie und adjuvanter Temozolomid-Chemotherapie behandelt werden.
    E.2.2Secondary objectives of the trial
    Secondary objectives are comparing progression-free survival and 6, 12 and 24 month OS and PFS rates, the safety profile, overall and neurological performance and the quality of life between the two treatment groups
    Sekundäre Studienziele sind die Evaluierung des progressionsfreien Überlebens (Progression-Free Survival, PFS) und der PFS and OS Raten nach 6, 12 und 24 Monaten, des Sicherheitsprofils der Therapie, der Lebensqualität der Patienten sowie ihrer allgemeinen und neurologischen Leistungsfähigkeit.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - newly diagnosed, monofocal GBM, IDH wildtype (WHO grade IV) confirmed by central neuropathology review
    - near-complete resection (≤ 5 ml residual tumor volume) confirmed by central neuroradiologist on magnetic resonance imaging (MRI) scan within 72 h postoperative
    - patients ≥ 18 years of age
    - Karnofsky performance status (KPS) ≥ 70% or ≥ 50% and minimal mental state examination
    ≥ 25
    - sterile tumor sample of ≥ 150 mg with tumor cell frequency ≥ 60% as determined by central neuropathologist available for vaccine production
    - successful production of sterile, avital tumor lysate
    - systemic corticosteroids tapered down to ≤ 2 mg of dexa-methasone or equivalent per day at baseline
    - adequate hepatic, liver and bone marrow function and blood coagulation
    - signed informed consent
    - neudiagnostiziertes, monofokales Glioblastom, Isozitratdehydrogenase Wildtyp (WHO Grad IV), das durch zentrale neuropathologische Überprüfung bestätigt wurde
    - fast vollständige Tumorresektion (≤ 5 ml Resttumor), bestätigt durch ein MRT innerhalb von 72 h und überprüft durch einen zentralen Neuroradiologen
    - Alter ≥ 18 Jahre
    - Karnofsky Status ≥ 70% oder ≥ 50% und minimal mental state examination ≥ 25
    - sterile Tumorprobe mit ≥ 150 mg und Tumorzellanteil ≥ 60% (durch zentralen Neuropathologen bestätigt) für Vakzineherstellung verfügbar
    - systemische Kortikosteroide ≤ 2 mg/d Dexamethason oder äquivalent zur Baseline Visite
    - unterschriebene Einverständniserklärung
    E.4Principal exclusion criteria
    - medical history of severe acute or chronic disease with poor prognosis, autoimmune disorder, immunodeficiency or organ allograft
    - infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis E (HEV) or Treponema pallidum or other severe infection requiring treatment
    -known allergy or intolerability to components of vaccine, to TMZ or to dacarbazine
    - severe myelosuppression
    - history of bleeding diathesis or coagulopathy
    - O6-methylguanine-DNA-methyltransferase (MGMT) promoter methylation status equivocal
    - dokumentierte Vorgeschichte einer schwerwiegenden oder chronischen Erkrankung mit schlechter Prognose, Autoimmunerkrankung, Immundefizienz oder Organtransplantation
    - Infektion mit Humanem Immundefizienz Virus, Hepatitis B Virus, Hepatitis C Virus, Hepatitis E Virus, Treponema pallidum oder andere schwere Infektion, die einer Behandlung bedarf
    - bekannte Allergie für eine Komponente der Vakzine, für TMZ oder Dacarbazin
    - Schwere Myelosuppression
    - Vorgeschichte einer schweren Blutungsneigung oder anderen Gerinnungsstörung
    - O6-Methylguanin-DNA-Methyltransferase (MGMT) Promotormethylierungsstatus nicht eindeutig.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is overall survival (OS) measured from the day of surgery until death.
    Überleben, berechnet vom Tag der Operation bis zum Tod (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    from day of surgery until death
    vom Tag des Eingriffs bis zum Tod
    E.5.2Secondary end point(s)
    - progression-free survival (PFS) as measured from the day of surgery until diagnosis of tumor progression by MRI scan according to modified Response Assessment in Neuro-Oncology (RANO) criteria or death due to any cause
    - OS and PFS rates at 6, 12 and 24 months after the day of surgery
    - safety based on the frequency and severity of adverse events (AE) with toxicity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events 4.03 (CTCAE 4.03)
    - overall and neurological performance based on the Karnofsky performance status and the Minimal Mental State Examination 2 (MMSE-2)
    - quality of life as determined by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 3.0 and Brain Cancer Module QLQ-BN20 as well as the Distress Thermometer (DT) and the Hospital Anxiety and Depression Scale (HADS) for psycho-oncological strain assessment
    - Progressionsfreies Überleben (berechnet vom Tag der Operation bis zum dokumentierten Progress/Tod)
    - OS und PFS Raten 6, 12 and 24 Monate nach der Operation
    - Sicherheit basierend auf der Frequenz und Schwere von Nebenwirkungen bewertet entsprechend der National Cancer Institute Common Terminology Criteria for Adverse Events
    - gesamt- und neurologische Performance basierend auf dem Karnofsky Status und der Minimal Mental State Examination
    - Lebensqualität basierend auf dem European Organization for Research and Treatment of Cancer Quality of Life Questionnaire QLQ-C30 3.0 und Brain Cancer Module QLQ-BN20 sowie dem Distress Thermometer und dem Hospital Anxiety and Depression Scale für die Beurteilung der psychoonkologischen Belastung
    E.5.2.1Timepoint(s) of evaluation of this end point
    6, 12 and 24 months after the day of surgery
    6, 12 und 24 Monate nach dem Tag des Eingriffs
    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 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 Yes
    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
    Standard Radiochemotherapie
    standard radiochemotherapy
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    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 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
    closure of data base
    Datenbankschluss
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months63
    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: 213
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 213
    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 state136
    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 of that condition
    Weiterbehandlung gemäß Routine
    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 Decision2018-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-25
    P. End of Trial
    P.End of Trial StatusOngoing
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