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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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:2011-000177-31
    Sponsor's Protocol Code Number:CAN-004B
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-25
    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 ConcernedGermany - PEI
    A.2EudraCT number2011-000177-31
    A.3Full title of the trial
    CANVAS: A Randomized Trial of Cvac (Autologous Dendritic Cells Pulsed with Recombinant Human Fusion Protein [Mucin 1-Glutathione S Transferase] Coupled to Oxidized Polymannose) as Maintenance Treatment in Patients with Epithelial Ovarian Cancer (EOC) in Second Remission
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of Cvac in patients with epithelial ovarian cancer (EOC).
    A.4.1Sponsor's protocol code numberCAN-004B
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01521143
    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 SponsorPrima BioMed
    B.1.3.4CountryAustralia
    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 supportPrima BioMed
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrima BioMed
    B.5.2Functional name of contact pointMedical Monitor; Frank Fliegert
    B.5.3 Address:
    B.5.3.1Street AddressUhlandstrasse 27
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10719
    B.5.3.4CountryGermany
    B.5.4Telephone number+4934123100373
    B.5.5Fax number+493069088666
    B.5.6E-mailfrank.fliegert@primabiomed.com.au
    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/3/10/776
    D.3 Description of the IMP
    D.3.1Product nameCvac
    D.3.4Pharmaceutical form Solution 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 INNUnknown
    D.3.9.3Other descriptive nameDC-M-FP
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60000000
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberSomatic cell therapy medicinal product EMA/CAT/350334/2010
    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
    Maintenance treatment in patients with epithelial ovarian cancer (EOC) with no evidence of disease (NED) following second remission defined as after response to second-line platinum-based therapy.
    E.1.1.1Medical condition in easily understood language
    Treatment of ovarian cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    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 assess the efficacy, in terms of overall survival (OS), of Cvac compared with observational standard of care following second remission in epithelial ovarian cancer (EOC).
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    • To assess the time to next treatment (TTNT) in patients after treatment with Cvac compared with observational standard of care
    • To assess the efficacy, in terms of progression-free survival (PFS), of Cvac compared with observational standard of care following second remission
    • To assess the safety and tolerability of Cvac compared with observational standard of care
    • To assess health-related quality of life (QoL) related to Cvac treatment compared with observational standard of care
    Exploratory Objectives
    • Investigate the utility of biomarkers as predictors or prognostic factors of clinical outcomes of Cvac
    • Investigate histopathology of tumor samples for potential markers of predictive clinical efficacy of Cvac
    • Evaluate immunologic response to Cvac administration
    • Assess the effect of Cvac on changes in ECOG performance status from baseline visit (defined as the visit within 2 weeks of the 1st dose) compared with observational standard of care
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients may be enrolled in and randomized to the study only if they meet all of the following criteria at screening and the baseline visit (defined as the visit within 2 weeks of the first dose):
    1. Females ≥ 18 years of age at screening with a confirmed diagnosis of epithelial ovarian, fallopian tube, or peritoneal cancer
    2. Underwent standard cytoreductive surgery and first-line chemotherapy containing platinum before first relapse and were in complete remission for at least 6 months prior to relapse
    3. Relapsed once and then underwent standard platinum-based second line chemotherapy (at least 3 cycles is required) with or without a second bulk-reducing surgery
    4. Second remission defined as:
    a. No definitive evidence of disease (NED) on CT or MRI of the abdomen and pelvis;
    b. CA-125 ≤ upper limit of normal (ULN) or 90% reduction in CA-125 since start of second-line chemotherapy;
    c. Negative physical exam (i.e., no clinical signs)
    5. Life expectancy ≥ 3 months in the opinion of the investigator
    6. Signed an informed consent form (ICF)
    7. Willing and able to complete study procedures within the expected study timelines
    8. Mucin 1-positive tumor as determined by central immunohistopathology
    9. Histologically documented EOC, fallopian tube, or peritoneal cancer (patients with pseudomyxoma, mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, i.e., patients with low malignant potential tumors, and with clear cell or mucinous histology are excluded)
    10. Adequate end-organ and hematological function as defined by:
    a. Adequate bone marrow function: white blood cells (WBCs) ≥ 3.0 K/µL, absolute neutrophil count (ANC) ≥ 1.5 × 109/L, hemoglobin ≥ 9 g/dL, and platelets ≥ 100 × 109/L
    b. Adequate renal function: serum creatinine ≤ 1.5 × ULN
    c. Adequate liver function: serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) and serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) ≤ 2 × ULN and serum bilirubin ≤ 1.5 × ULN
    11. Generally well-controlled blood pressure with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg prior to randomization (antihypertensive medications are permitted). Low-dose chronic hormonal or steroidal treatments are also permitted.
    12. Not pregnant, and if of childbearing potential, agrees to use a highly effective method of birth control (implanted, injectable, or oral combination hormonal method alone or in possible combinations, intrauterine device, vasectomized partner, or abstinence) prior to study entry, for the duration of the study, and for 3 months after the last dose of study agent. Male partners of a study patient must use a condom in addition to the acceptable method of contraception for the female partner as specified above
    13. ECOG status of 0 or 1 (applicable at the baseline visit only).
    E.4Principal exclusion criteria
    Patients are to be excluded from the study at the time of screening and the baseline visit (defined as the visit within 2 weeks of the first dose) for any of the following reasons:
    1. More than 2 previous lines of chemotherapy for EOC, fallopian tube, or peritoneal cancer
    2. Primary platinum-refractory or platinum-resistant disease (i.e., patients who progress prior to cessation of induction therapy [platinum refractory] or recur within 6 months after cessation [platinum resistant])
    3. Treatment with any investigational product (for any condition) within 4 weeks of screening. Enrolled in or has not completed at least 28 days (prior to screening) since ending another investigational device or drug treatment, or currently receiving other investigational treatments
    4. Concurrent systemic treatment with steroids or other immunosuppressant agents at a dose considered by the investigator to be higher than a standard physiological dose
    5. Evidence of severe or uncontrolled cardiac disease, including myocardial infarction or unstable angina within 6 months of screening, congestive heart failure, or ventricular arrhythmias requiring medication
    6. Diagnosed immunodeficiency or autoimmune disorder
    7. Infection with human immunodeficiency virus (HIV) or hepatitis C virus (HCV), or active and infectious hepatitis B virus (HBV) infection
    8. Pregnant or lactating/breastfeeding
    9. Evidence or history of central nervous system metastasis
    10. Known hypersensitivity to any of the components of the study agent
    11. Any unresolved persistent toxicities from prior systemic therapy that are either Grade 3 or Grade 4 (except alopecia) per the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
    12. Intent to treat patient with both an anti-angiogenesis therapy (such as bevacizumab) and a PARP inhibitor as part of maintenance therapy. Only one or the other are permitted while the patient is on study and must be started between the baseline visit and Visit 1 if it will be used as part of the patient’s maintenance therapy regimen
    13. Prior malignant diseases, unless the patient has been in full remission for a minimum of 2 years, except carcinoma in situ of the cervix or basal cell and squamous cell carcinomas of the skin (note: rationale for contraindication for existing and prior malignant diseases unless the patient has been in complete remission for an entire 2 years unless exceptions for in situ carcinoma or the cervix or basal cell or squamous cell carcinoma or the skins is provided in the investigator’s brochure)
    14. Active, uncontrolled, ongoing infection.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is overall survival (OS). OS is defined as the number of days elapsed between the randomization date and the date of death (regardless of cause). A secondary analysis of OS will use the baseline visit as the reference starting date.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 210 patients will be recruited and randomized into the trial. Upon either completing or discontinuing the treatment phase of the study, patients will then be followed for OS and PFS. OS will be monitored every 24 weeks after confirmation of progressive disease (PD). PFS will be radiologically assessed at intervals of approximately 12 weeks at the site until PD, death, or until the end of the study if a patient does not progress or die during the study. Radiological scans will be evaluated at the site for determination of progression, and must be kept for potential later evaluation by an independent radiologist.













    E.5.2Secondary end point(s)
    Time to next treatment (TTNT) is defined as the number of days from the randomization date to the date when a next treatment for EOC is started.

    Progression free survival (PFS) is defined as the number of days from the randomization date to the earliest of documented disease progression or death without prior progression.

    Each patient will be assessed for progressive disease (PD) every 12 weeks beginning at the baseline visit, until PD is determined by the investigator, or until death, or until the end of the study, whichever occurs first.

    The investigator shall continue with PD evaluations until determination of either unequivocal PD or confirmed equivocal PD (see definitions in Section 9.2 of the protocol).

    A secondary analysis of TTNT and PFS will use the baseline visit as the reference starting date.

    Safety and tolerability will be assessed by the following:
    • Adverse events evaluated according to the National Cancer Institute (NCI) CTCAE version 4
    • Clinically relevant changes from the baseline visit in vital signs
    • Clinically relevant changes from the baseline visit in 12-lead electrocardiogram (ECG)
    • Clinically relevant changes from the baseline visit in physical examinations
    • Clinically relevant changes from the baseline visit in safety laboratory assessments (hematology with differential count, biochemistry, and urinalysis)
    • Clinically relevant autoantibody laboratory assessments.

    Quality of life will be assessed using the following:
    • European Organisation for Research and Treatment of Cancer–Quality of Life Questionnaire (EORTC QLQ-C30, version 3)
    • OV28 Module to EORTC QLQ
    • EuroQol Group EQ-5D-3L.

    Other and exploratory analyses:
    • Change in ECOG performance status from the baseline visit
    • Human leukocyte antigen (HLA) genotyping and breast cancer gene (BRCA) status from patients where data are available
    • Immunological assays
    • Assess the utility of biomarkers as predictors of PFS and/or OS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See Protocol Table 1 for Schedule of Assessments. Each patient will be assessed for PD at the clinical site at intervals of approx. 12 weeks, until PD is determined, or until death, or study end, whichever occurs first for the patient.
    Radiological scans should be performed using the same technique (CT or MRI) throughout the entire study, if possible.
    As all patients must be deemed to have no evidence of disease at baseline to continue on study, disease progression thereafter will be defined as any measurable new lesion(s) that can be accurately measured in at least one dimension.
    A secondary analysis of TTNT and PFS will use the baseline visit date as the reference starting date.
    QoL will be assessed at baseline, after each dose of study agent, and at PFS Follow-Up Visits.
    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
    Observational standard of care
    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 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
    Belarus
    Belgium
    Bulgaria
    Germany
    Latvia
    Lithuania
    Poland
    Ukraine
    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
    12 weeks after Visit 7 (± 1 week), and every 12 weeks thereafter (± 1 week), until unequivocal PD or death, or until the end of study (whichever occurs first), patients will attend a PFS Follow-Up Visit.
    After PD, investigators will continue to contact patients or caretakers to assess overall survival approximately every 24 weeks until death or the end of the study.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 189
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 159
    F.4.2.2In the whole clinical trial 210
    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)
    Patients will continue to receive standard of care treatment.
    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 Decision2014-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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