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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:2014-000676-26
    Sponsor's Protocol Code Number:CAN-301-DE
    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:2014-05-21
    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 ConcernedGermany - PEI
    A.2EudraCT number2014-000676-26
    A.3Full title of the trial
    A Phase 2 Trial of Cvac (Autologous Dendritic Cells Pulsed with Recombinant Human Fusion Protein [Mucin 1-Glutathione S-Transferase] Coupled to Oxidized Polymannose) in Patients with Resected Stage I or Stage II
    Adenocarcinoma (Cancer) of the Pancreas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of Cvac in patients with pancreatic cancer
    A.4.1Sponsor's protocol code numberCAN-301-DE
    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 Ltd
    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 Ltd
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrima BioMed Ltd
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressDeutscher Platz 5E
    B.5.3.2Town/ cityLeipzig
    B.5.3.3Post code04103
    B.5.3.4CountryGermany
    B.5.4Telephone number+4934123100373
    B.5.5Fax number+493069088666
    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 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) 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 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 with Cvac in patients with resected stage I or stage II adenocarcinoma (cancer) of the pancreas
    E.1.1.1Medical condition in easily understood language
    Treatment of pancreatic cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10033609
    E.1.2Term Pancreatic carcinoma
    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 safety and tolerability of Cvac in patients with resected stage I or stage II adenocarcinoma (cancer) of the pancreas
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    • To assess the duration of Progression-Free Survival (PFS) and Overall Survival (OS) following the initiation of Cvac in this patient population

    Exploratory Objectives
    • To evaluate the time to next treatment (TTNT)
    • To evaluate immunologic response to Cvac administration in this patient population
    • To investigate biomarkers, including tumor and immune characteristics, of clinical efficacy of Cvac in this patient population
    • To assess the change in quality of life (QoL) following the initiation of Cvac in this patient population
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients may be enrolled if they meet all of the following criteria at screening:
    1. Histologically or cytologically diagnosed adenocarcinoma of the pancreas, stage I or stage II disease;
    2. Postoperative confirmed R0 or R1 resection status with no evidence of residual disease based on radiographic imaging;
    3. CA 19-9 less than 2 × the ULN by the central laboratory;
    4. No greater than 6 weeks since completion of prior therapy, which includes surgery with or without radiation or chemotherapy;
    5. Mucin 1-positive tumor as determined by central immunohistopathology. Sites will be asked to submit archival tissue (patients may start the study if tissue is available at an outside hospital, but not yet requested or received);
    6. Signed an ICF;
    7. Willing and able to complete study procedures within the study timelines;
    8. Life expectancy of at least 6 months in the investigator’s opinion;
    9. ≥ 18 years of age;
    10. ECOG performance status < 2 (Karnofsky ≥ 70%);
    11. Normal organ and marrow function: serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN and serum bilirubin ≤ 1.5 × ULN unless Gilbert’s syndrome has previously been confirmed for the patient, white blood cells (WBCs) ≥ 3.0 K/µL, absolute neutrophil count (ANC) ≥ 1.0 × 109/L, hemoglobin ≥ 8 g/dL, and platelets ≥ 100 × 109/L;
    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 Cvac. 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.
    E.4Principal exclusion criteria
    1. Active, acute, or chronic clinically significant infections or bleeding;
    2. Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg) or history of congestive heart failure (≥ Grade 2);
    3. Active angina pectoris, stroke, or recent myocardial infarction (within 6 months);
    4. Additional uncontrolled, serious medical or psychiatric illness;
    5. Evidence or history of central nervous system metastases;
    6. Inadequate renal function defined as a creatinine clearance < 60 mL/min as determined by the central laboratory;
    7. Additional malignancy diagnosed within 5 years of study enrolment, except carcinoma in situ of the cervix or basal cell and squamous cell carcinomas of the skin;
    8. Treatment with any other investigational agent (for any condition) within 4 weeks of screening;
    9. Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis (Treponema pallidum [TPHA]);
    10. Concurrent systemic treatment with steroids or other immunosuppressant agents at a dose considered by the investigator to be higher than a standard physiological dose;
    11. Active autoimmune disease; any previous autoimmune disease must not require chronic treatment in the 6 months prior to screening;
    12. Oversensitivity to the substances or another component of the investigational medicinal product.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and Tolerability
    E.5.1.1Timepoint(s) of evaluation of this end point
    See Protocol Table 1 for Schedule of Safety and Tolerability Assessments

    Safety and tolerability will be assessed by the following:
    • Adverse events evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
    • Clinically relevant changes from baseline in vital signs
    • Clinically relevant changes from screening in 12-lead ECG
    • Clinically relevant changes from baseline in physical examinations
    • Clinically relevant changes from baseline in safety laboratory assessments (haematology with differential count, biochemistry, and urinalysis)
    • Clinically relevant autoantibody laboratory assessments
    E.5.2Secondary end point(s)
    EFFICACY ENDPOINTS
    The efficacy endpoints for this pilot study include OS and PFS.
    OS is defined as the number of days between the start date of treatment with Cvac and the date of death from any cause. The duration of OS will be right-censored based on the date the patient was last known to be alive for those who are alive or lost to follow-up as of the data analysis cut off date.

    PFS is defined as the number of days between the start date of treatment with Cvac and the earlier of documented disease progression as defined by RECIST criteria or death without prior progression. The date of disease progression or censoring for PFS will be determined according to the conventions listed in the May 2007 FDA Guidance for Industry, ‘Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics’ (www.fda.gov/cder/guidance/7478fnl.htm).

    QUALITY OF LIFE
    Change from baseline for the following QoL measures:
    • European Organization for Research and Treatment of Cancer–Quality of Life Questionnaire (EORTC QLQ-C30, version 3)
    • Module QLQ-PAN26

    EXPLORATORY ENDPOINTS
    • Time to Next Treatment (TTNT)
    • Change in immunologic parameters
    • Change in CA 19-9
    • Change in ECOG performance status
    • Change in tumour and immune biomarkers (protein and RNA)

    DEFINITIONS
    • TTNT is defined as the time from baseline (Week 0) to the date when a next treatment for EOC is started.
    • PFS is defined as the time from baseline (Week 0) to the date of the radiological scan used to determine PD or date of death from any cause (PFS event).
    • Each patient will be assessed for PD per standard of care at the clinical site, until PD is determined by the investigator, or until death, or until end of study, whichever occurs first for the patient.
    • Radiological scans should be performed using the same technique (CT or MRI) throughout the study if possible.
    • QoL will be assessed at baseline, after each dose of study agent, and at PFS Follow-Up Visits.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See Protocol Table 1 for Schedule of Efficacy and Other Assessments

    OVERALL SURVIVAL
    After documented PD, approximately every 24 weeks for at least 3 years following baseline or until death or the end of the study, investigators will continue to contact patients or caretakers to assess survival.

    PROGRESSION-FREE SURVIVAL
    Each patient will be assessed for PD at approximately 12 weeks after baseline, and then every 12 weeks thereafter, until PD is determined by the investigator, or until death, or until the end of the study, whichever occurs first. For any patients who progress and continue to receive Cvac, the date and type of response (e.g., stable disease, disease progression) should be collected for any subsequent radiological scans completed.
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    DURATION OF THE STUDY:
    Patient enrollment is expected to occur over approximately 12 months.
    The maximum time on study is estimated at approximately 47 months (screening period, 44 weeks of treatment, and 36 months of post-treatment evaluation). Follow-up visits will be made every 12 weeks until PD and then telephone contacts every 24 weeks until, death or end of study, whichever occurs first .
    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: 35
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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. The maximum time on study is estimated at approximately 47 months (screening period, 44 weeks of treatment, and 36 months of post-treatment evaluation).
    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 Opinion2014-07-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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