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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-001977-13
    Sponsor's Protocol Code Number:020221
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2013-02-11
    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 number2011-001977-13
    A.3Full title of the trial
    A Phase III clinical trial evaluating DCVax®-L, autologous dendritic cells (DC) pulsed with tumor lysate antigen for the treatment of glioblastoma multiforme (GBM)
    Klinische Phase III Studie zur Evaluierung von DCVax®-L - autologe
    dendritische Zellen beladen mit Tumor-Lysat Antigen zur Behandlung von
    Glioblastoma multiforme (GBM).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial Evaluating DCVax®-L, Self-Derived Dendritic Cells Loaded
    with Tumor Proteins for the Treatment of Glioblastoma, a Type of Brain
    cancer
    A.3.2Name or abbreviated title of the trial where available
    DCVax-L trial for GBM
    A.4.1Sponsor's protocol code number020221
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00045968
    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 SponsorNorthwest Biotherapeutics, Inc
    B.1.3.4CountryUnited States
    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 supportNorthwest Biotherapeutics, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNorthwest Biotherapeutics BV
    B.5.2Functional name of contact pointMarnix Bosch
    B.5.3 Address:
    B.5.3.1Street AddressKingsfordweg 151
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1043GR
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+316 3866 7526
    B.5.5Fax number+31206120203
    B.5.6E-mailMarnix@nwbio.com
    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/3/07/431
    D.3 Description of the IMP
    D.3.1Product nameDCVax-L
    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 INNNA
    D.3.9.3Other descriptive nameAUTOLOGOUS DENDRITIC CELLS LOADED WITH AUTOLOGOUS TUMOR CELL LYSATE
    D.3.9.4EV Substance CodeSUB99905
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1250000
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Glioblastoma multiforme
    E.1.1.1Medical condition in easily understood language
    Brain cancer, stage 4
    Gehirnkrebs, Stage 4
    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 PT
    E.1.2Classification code 10018337
    E.1.2Term Glioblastoma multiforme
    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 compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma. This endpoint will be assessed using 3 different analyses.
    E.2.2Secondary objectives of the trial
    The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence and control patients from comparable, contemporaneous clinical trials, in patients with recurrent GBM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Determined at pre-screening
    • Patients ≥18 and ≤70 years of age at time of surgery
    • Patients must be able to understand and sign the informed consent indicating that they are aware of the investigational nature of this study. The consent for tumor donation may be signed by a legally authorized representative (LAR) if allowed by the institution.
    • Patients must have a life expectancy of ≥8 weeks

    Determined at or around surgery, and prior to pre-leukapheresis visit
    • Primary therapy must consist of surgical resection with the intent for a gross or near gross total resection of the contrast-enhancing tumor mass as confirmed by central review, followed by external beam radiation therapy and concurrent temozolomide chemotherapy. Patients who have a resection with original intent for gross or near gross total resection where the surgery can be said to be beyond biopsy are eligible. Central confirmation is not required prior to the pre-leukapheresis visit, but is required before the patient can proceed to leukapheresis. Patients having a biopsy only will be excluded. Patients may be screened if they have had a previous biopsy and are scheduled for a subsequent gross or near gross total resection prior to commencement of other therapies.
    • Patients with newly diagnosed, unilateral GBM (Grade IV) without metastases are eligible for this protocol. An independent central neuropathologist will review this diagnosis during the enrollment process. This confirmation is not required prior to the pre-leukapheresis visit, but is required before the patient can proceed to leukapheresis.
    • All Patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material. This determination will be made by the contracted manufacturer and communicated to the clinical site through the Sponsor, or its designee. This confirmation is not required prior to the pre-leukapheresis visit, but is required before the patient can proceed to leukapheresis.

    Determined at pre-leukapheresis visit
    • Patients must have adequate bone marrow function prior to each leukapheresis procedure (hemoglobin >10 g/dl or >100g/L, white blood count ≥ 3.6x10E3/mm3 or ≥ 3.6x10E9/L, absolute granulocyte count ≥1.5x10E3/mm3 or ≥1.5x10E9/L, absolute lymphocyte count ≥0.5x10E3/mm3 or ≥0.5x10E9/L, and platelet count ≥100x10E3/mm3 or ≥100x10E9/L). Patients for whom a transfusion is clinically indicated may be considered eligible based on post-transfusion Hgb levels. These values are determined by a central laboratory.
    • Adequate liver function (SGPT, SGOT, and alkaline phosphatase ≤4.0 times upper limits of normal (ULN) and total bilirubin ≤1.5 mg/dl or <25.7 μmol/L), and adequate renal function (BUN or creatinine ≤1.5 times ULN) prior to starting therapy. These values are determined by a central laboratory.

    Determined at baseline visit
    • Patients must have a KPS rating of ≥70 at the Baseline Visit (Visit 5)
    • Patients may have received steroid therapy as part of their primary treatment. Steroid treatment should preferably be stopped; or if continued steroid use is clinically indicated, be tapered down to no more than 4 mg dexamethasone per day (or equivalent) at least 7 days prior to the first immunization.
    • Patients must be willing to forego cytotoxic anti-tumor therapies except temozolomide while being treated with study drug/placebo. DCVax-L and placebo must be given as described and temozolomide must be given essentially according to the Stupp Protocol guidelines. Administration of adjuvant temozolomide is minimally modified from the guidelines to allow for vaccine dose window adherence.
    • A minimum of 5 immunizations must be available for treatment as determined by the contracted manufacturer.
    E.4Principal exclusion criteria
    Determined at pre-screening
    • History of prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or other cancers that were deemed fully resolved 5 or more years prior to Visit 1 (surgery) of the study. Prior lower grade gliomas are acceptable unless treated with chemotherapy, and provided that all other eligibility criteria are met.
    • History of immunodeficiency disease or unresolved autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or vasculitis.
    • Known HIV-1,2, HTLV-1,2 or Hepatitis B, C infection
    • Pregnancy
    • Inability to obtain informed consent because of psychiatric or complicating medical problems.
    • Any known genetic cancer-susceptibility syndromes.

    Determined at or around surgery
    • Bilateral or metastatic disease detected at diagnosis, during surgery or at post-surgical magnetic resonance imaging (MRI). Tumors may cross into, but not beyond the corpus callosum.
    • Positive test(s) for infectious agents (HIV 1 and 2, Anti-HIV-1,2, Hepatitis B, HBsAg, Anti HBc, Hepatitis C, Anti-HCV-Ab, Syphilis) that would preclude eligibility for tumor procurement and processing per applicable manufacturing guidelines (e.g. German manufacturing vendors).
    • Post operative MRI scan evidence of biopsy only without significant tumor resection.
    • Implantation of Gliadel® wafers (polifeprosan 20 with carmustine implant) at surgery.

    Determined at pre-leukapheresis visit
    • Positive HIV-1, HIV-2, HTLV-1, 2, hepatitis B surface antigen, or hepatitis C antibody.
    • Patients with organ allografts.
    • Allergies to reagents used in this study.
    • Patients who are unable to stop or taper steroid treatment to no more than 4mg of dexamethasone per day (or equivalent) prior to leukapheresis are excluded from the trial; steroid use should be stopped or tapered down to the lowest clinically acceptable dose approximately 7 days prior to leukapheresis. The Leukapheresis Visit must occur a minimum of 45 days before the projected Baseline Visit.
    • Inability or unwillingness to return for required visits and follow-up exams.
    • Any previous cytotoxic drug therapies within the last 5 years.

    Determined at or prior to baseline visit
    • Patients who have evidence of disease progression (including possible pseudoprogression) as determined by central review
    • Patients may not be taking medications that might affect immune function and that have documented anti-tumor activity: The following are exceptions: nonprescription strength doses of NSAIDS, acetaminophen (paracetamol) or acetylsalicylic acid (aspirin).

    Determined at baseline visit:
    • Acute infection: any active viral, bacterial, or fungal infection that requires specific therapy. Antibiotic therapy must be completed at least 7 days prior to the first immunization.
    • Active uncontrolled infection. Examples are a sexually transmitted disease (STD), herpes, uncontrolled tuberculosis, malaria, etc.
    • Fever ≥101.5°F (38.6 °C). If considered possibly transient, retesting is allowed.
    • Unstable or severe intercurrent medical conditions such as unstable angina, uncontrolled arrhythmias, ulcerative colitis etc.
    • Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (abstinence, surgical, hormonal or double barrier, i.e. condom and diaphragm).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is overall survival (OS) compared between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma.
    E.5.1.1Timepoint(s) of evaluation of this end point
    October 2020
    E.5.2Secondary end point(s)
    The first secondary endpoint is overall survival (OS) compared between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in patients with recurrent GBM.
    The second secondary endpoint, confirmed progression-free survival (cPFS), is confirmed disease progression (cPD) compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
    The third secondary endpoint, PFS, is progression-free survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
    The fourth secondary objective, OS, is overall survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
    The fifth secondary objective is tumor response compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
    E.5.2.1Timepoint(s) of evaluation of this end point
    October 2020
    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) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Germany
    United Kingdom
    United States
    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 years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 298
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state87
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 132
    F.4.2.2In the whole clinical trial 348
    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)
    Current standard of care of that condition by their physcians.
    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 Decision2013-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-04
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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