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    Summary
    EudraCT Number:2013-003045-42
    Sponsor's Protocol Code Number:CV-005
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-21
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-003045-42
    A.3Full title of the trial
    An Open-labelled, Randomized Phase II Multicentre Study to Investigate Efficacy of Autologous Lymphoid Effector Cells Specific Against Tumour-Cells (ALECSAT) in Patients with Glioblastoma Multiforme Measured as Progression Free Survival Compared to Avastin/Irinotecan
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical Phase II Multicentre Study to Investigate Efficacy of Autologous Lymphocytes (ALECSAT) in Patients with Glioblastoma Multiforme Measured as Progression Free Survival Compared to Avastin/Irinotecan
    A.4.1Sponsor's protocol code numberCV-005
    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 SponsorCytoVac A/S
    B.1.3.4CountryDenmark
    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 supportCytoVac A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCytoVac A/S
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressVenlighedsvej 6
    B.5.3.2Town/ cityHørsholm
    B.5.3.3Post code2970
    B.5.3.4CountryDenmark
    B.5.4Telephone number4545572245
    B.5.5Fax number4545572240
    B.5.6E-mailcle@cytovac.dk
    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 nameALECSAT
    D.3.2Product code PR1
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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) Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Bevacizumab and Irinotecan in combination
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Concentrate and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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
    The overall purpose of the study is to investigate the efficacy and safety of ALECSAT in GBM patients either with relapse of GBM after first line treatments (followed by reoperation if possible). The efficacy and safety of ALECSAT treatment is, compared to standard Avastin/Irinotecan econd line treatments for these patients.
    E.1.1.1Medical condition in easily understood language
    Advanced brain cancer Glioblastoma multiforme
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To compare progression free survival (PFS) in patients with relapsed GBM when the patients are either treated with ALECSAT immunotherapy or standard praxis therapy with Avastin/Irinotecan.The included patients disease has relapsed during or after receceiving recongnized first-line treatments. Progression of disease is defined according to the response ecaluation criteria for solid (RANO)
    E.2.2Secondary objectives of the trial
    • To evaluate the overall survival (OS) during the study period in patients treated with ALECSAT compared to patients treated with Avastin/Irinotecan by Kaplan-Meier methodology
    • To evaluate time to progression in the two treatment groups
    • To compare PFS in the two treatment groups by Kaplan-Meier methodology
    • To compare PFS in a landmark analysis in the two treatment groups after a duration of 6 and 12 months after initiation of treatment
    • To compare ORR
    • To investigate QoL and performance status during the study period for patients treated with ALECSAT compared to patients treated with Avastin/Irinotecan
    • To investigate any changes in leucocytes and lymphocytes during the study period for patients receiving ALECSAT
    • To investigate radiological changes as measured by MRI during the study period for the ALECSAT group and compare the results with the Avastin/Irinotecan treated group
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patients must meet the following criteria in order to be eligible for inclusion in the study:
    1. Histologically confirmed GBM tumour with recurrence during or after completing the first-line treatments, documented by MRI
    2. Minimum age of 18 years old Capable of understanding the information and giving informed consent
    3. Minimum height of 155 cm
    1. Expected survival time (life expectancy) of over 3 months
    2. Adequate performance status £ 2 (see below*)
    3. Clinically normal EVF
    4. Women in fertile conditions can only be included with a negative pregnancy test at screening and must use appropriate contraceptives during the study
    E.4Principal exclusion criteria
    Criteria which exclude the patient for entering in the study are:
    1. Positive tests for anti-HIV-1/2; HBsAg, anti-HBc, Anti-HCV or being positive in a Treponema Pallidum test (syphilis)
    2. Patients which have visit an area where there is an outbreak of West Nile virus or Dengue virus within 28 days prior to donation should be excluded, unless the patient has been tested negative
    3. Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation
    4. Clinically significant autoimmune disorders or conditions of immune suppression
    5. Hemoglobin count ≤ 7.5mmol/l (men & women)
    6. Lymphocyte-numbers below 0.5 x 109/l
    7. Body weight below 40 kg (men) and 50 kg (women)
    8. Clinically abnormal ECG as judged by the Investigator
    9. Pregnant or breast feeding women
    10. Inclusion in other clinical studies 4 weeks prior to inclusion in the study
    11. Any medical condition that will render participation in the study risky or, according to the Investigator will make the assessment of the study endpoints difficult
    12. Treatment with any immunotherapy, cytotoxic therapy or, biologic therapy 4 weeks prior to enrolment in this study
    13. Patienys that either put a risk due to the blood donation or where it is not expected taht an ALECSAT product of good quality van be produced
    14. Patients with uncontrolled serious bacterial, viral , fungal or parasitic infection
    15. Blood transfusion within 48 hours prior to donation of blood for LECSAT production
    16Known or suspected intolerance to Avastin, Irinotecan or any of the excipients as well as intolerance to recombiant humanized antibodies
    17. Performance status >3
    E.5 End points
    E.5.1Primary end point(s)
    • PFS, progreesion-free survival, measured by MRI according to RANO at specific time points during the study period, to be analysed when top-line data are obtained after 124 PFS events or after LSLV in case of the total number of PFS events ending up being less that 124
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    Efficacy Endpoints
    • OS (Overall Survival), the number of patients still alive at the end of study (EoS)
    • Time to progression
    • PFS time to event analysis (Kaplan-Meier) upon study completion, inthe cases of topline results after 124 evebts published before LSLV
    •PFS landmark after duration of 6 month from initiation of treatment as measured by MRI according to RANO at specific time points during the study period
    •
    • PFS landmark at 12 months
    • ORR (Objective Response Rate) defined as the response rate of patients having a complete (CR) or partial response (PR) within the two treatment groups
    • Evaluate outcome of patients response to QoL questionnaire (Appendix 3) and performance status in the two treatment groups at specific time points during the study period
    • Changes in leucocytes and lymphocytes in the ALECSAT arm at specific time points during the study period.
    • Changes in tumour size measured by MRI

    Safety Endpoints
    • Comparison of type and frequency of AEs
    • Changes in biochemical parameters of clinical relevance
    • Changes in hematology parameters of clinical relevance
    • Changes in vital signs
    • Evaluation of medical events of special interest
    • Changes in electrocardiogram (ECG)

    Exploratory Endpoints
    • Use of corticosteroid for each patient during study
    • Differences in level and variability between the tumour measurements provided by Investigator and by the blinded radiologist
    • To compare the two groups with respect to reoperation / no reoperation, tumour size, histo-pathologic diagnosis and genomic diagnosis using O6-methylguanine-DNAmethyltransferase (MGMT) at the time of allocation in the study
    • Changes in tumour size measured by 18F-FET/PET (PET only at sites having PET equipment)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At specific time points during the study period
    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 No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Bevacizumab and Irinotecan in combination
    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 concerned2
    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
    The primary efficacy endpoint is the landmark defined as the proportion of patients having PFS after a duration of 6 months from first IMP (PFS6). PFS is defined as the time from the date of randomization to the day of documented disease progression or death due to any cause. It will be based on tumour assessments made according to the RANO. All tumour assessments obtained during the study until the EoS visit, i.e. both treatment phase and follow-up phase, will be included in this analysis.
    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 months19
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state175
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 175
    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)
    The patients in the two treatment groups will be followed for up to 62 weeks by planned study visits. Patients with, at least, stable disease will continue the allocated treatment after the study period as judged by the Investigator.
    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 Decision2013-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-12
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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