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    Summary
    EudraCT Number:2013-001325-24
    Sponsor's Protocol Code Number:SOV03
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-01
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2013-001325-24
    A.3Full title of the trial
    A randomized, open-label, parallel group, multi-center Phase II clinical
    trial evaluating effect of addition of DCVAC/OvCa to standard
    chemotherapy in women with relapsed platinum resistant epithelial
    ovarian carcinoma
    Randomizované, otevřené, multicentrické klinické hodnocení fáze II s paralelními skupinami, vyhodnocující účinek přídání přípravku DCVAC/OvCa ke standardní chemoterapii u žen s recidivujícím epiteliálním ovariálním karcinomem rezistentním k platině
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation and efficacy and safety of DCVAC/OvCa (therapeutic ovarian cancer vaccine) in woman with relapsed platinum resistant epithelial ovarian carcinoma
    A.4.1Sponsor's protocol code numberSOV03
    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 SponsorSOTIO a.s.
    B.1.3.4CountryCzech Republic
    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 supportSOTIO a.s.
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSOTIO a.s.
    B.5.2Functional name of contact pointClinical Trial Sotio
    B.5.3 Address:
    B.5.3.1Street AddressJankovcova 1518/2
    B.5.3.2Town/ cityPraha
    B.5.3.3Post code17000
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420224175111
    B.5.5Fax number+420224175498
    B.5.6E-mailclinicaltrial@sotio.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDCVAC/OvCa
    D.3.2Product code DCVAC/OvCa
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDCVAC/OvCa
    D.3.9.2Current sponsor codeDCVAC/OvCa
    D.3.9.3Other descriptive nameCELL SUSPENSION CONTAINING DENDRITIC CELLS
    D.3.9.4EV Substance CodeSUB120526
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000000
    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) 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
    epithelial ovarian carcinoma
    E.1.1.1Medical condition in easily understood language
    epithelial ovarian carcinoma
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10061328
    E.1.2Term Ovarian epithelial 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 determine the effect of adding DCVAC/OvCa to Standard of Care
    chemotherapy on OS in women with ovarian cancer who experienced
    relapse ≤6 months after achieving complete remission following
    standard first line (Pt-based) chemotherapy or did not reach complete
    remission
    E.2.2Secondary objectives of the trial
    Progression free survival (PFS)

    Objective response rate (ORR) = complete response(CR) + partial
    response (PR)

    Biological progression free interval

    Immunological response

    Safety

    Changes in quality of life (QoL)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Female aged ≥18 years
    Patients with histologically confirmed, FIGO (Féderation Internationale
    de Gynécologie et d’Obstétrique) stage III epithelial ovarian, primary
    peritoneal, or fallopian tube carcinoma (serous, endometrioid or
    mucinous), who have undergone initial or interval debulking surgery
    but have not reached complete remission of more than 6 months after
    first line Platinum (Pt) based chemotherapy, for one of the following
    reasons:
    Patients are Pt-refractory (no response)
    Complete remission was not reached (partial responders)
    Relapse within ≤6 months of remission (Pt-resistant)

    Pt-based chemotherapy failure should have been confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI) scan (Pt-resistant) or by finding described as ‘did not reach complete clinical remission’ (Pt-refractory or Pt-partial response)

    Patients must have at least one measureable target lesion as defined by
    the RECIST 1.1 criteria

    Laboratory criteria (results must be obtained <14 days before randomization, including results obtained before giving informed consent):
    White blood cells (WBC) >4,000/mm3 (4.0 x109/L)
    Neutrophil count >1,500/mm3 (1.5 x109/L)
    Hemoglobin of at least 10g/dL (100g/L)
    Platelet count of at least 100,000/mm3 (100 x109/L)
    Total bilirubin within normal limits (benign hereditary hyperbilirubinaemias, e.g. Gilbert´s syndrome are permitted)
    Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2x upper limit of normal (ULN), serum
    creatinine ≤2.0mg/dL
    Blood Urea Nitrogen (BUN) <2.0x ULN

    Adequate coagulation parameters (results must be obtained <14 days before randomization, including results obtained before giving
    informed consent):
    Activated partial thromboplastin time (APTT) ≤1.5x ULN and
    International Normalized Ratio (INR) ≤1.5

    Life expectancy of at least 12 months based on Investigators judgment

    Eastern Cooperative Oncology Group (ECOG) Performance status 0−2

    Signed informed consent including patient’s ability to comprehend its
    contents

    Females of childbearing potential must have had a negative serum
    pregnancy test at screening (β-human chorionic gonadotropin [β-HCG])
    E.4Principal exclusion criteria
    FIGO I,II,IV epithelial ovarian cancer

    FIGO III clear cells epithelial ovarian cancer

    Non-epithelial ovarian cancer

    Borderline tumors (tumors of low malignant potential)

    Prior or current systemic anti-cancer therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor [VEGF] therapy or hormonal therapy) except first line Pt-based chemotherapy (with or without bevacizumab)

    Previous radiotherapy to the abdomen and pelvis

    Malignancy other than epithelial ovarian cancer, except those that have
    been in CR for a minimum of 3 years, and except carcinoma in-situ of
    the cervix or non-melanoma skin carcinomas

    Patient co-morbidities:
    Human immunodeficiency virus (HIV) positive, human
    T-lymphotropic virus (HTLV) positive
    Active hepatitis B (HBV), active hepatitis C (HCV), active
    syphilis
    Evidence of active bacterial, viral or fungal infection requiring
    systemic treatment
    Clinically significant cardiovascular disease including:
    Symptomatic congestive heart failure
    Unstable angina pectoris
    serious cardiac arrhythmia requiring medication
    Uncontrolled hypertension
    Myocardial infarction or ventricular arrhythmia or stroke
    within a 6 month period before inclusion, ejection fraction
    (EF) <40% or serious cardiac conduction system
    disorders, if a pacemaker is not present Pleural and pericardial effusion of any National Cancer Institute
    (NCI) common terminology criteria for adverse events (CTCAE)
    grade
    Peripheral neuropathy having a CTCAE ≥Grade 2
    Active autoimmune disease requiring treatment
    History of severe forms of primary immune deficiencies
    History or anaphylaxis or other serious reaction following
    vaccination
    Uncontrolled co-morbidities including, psychiatric or social
    conditions which, in the Investigator’s opinion, would prevent
    participation in the trial

    Known hypersensitivity to any constituent in the DCVAC/OvCa

    Systemic immunosuppressive therapy for any reason

    Refusal to sign the informed consent

    Participation in a clinical trial using experimental therapy within the
    last 4 weeks before study entry; patients previously enrolled in protocol
    SOV01 who did not receive treatment with DCVAC/OvCa can be
    included in this study

    Fertile woman of childbearing potential not willing to use adequate
    contraception for the study duration and at least six months afterwards
    Pregnant or lactating women
    E.5 End points
    E.5.1Primary end point(s)
    OS (overall survival) defined as the time from randomization until death due to any cause
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from randomization until death due to any cause
    E.5.2Secondary end point(s)
    PFS measured by modified RECIST (Response Evaluation Criteria In
    Solid Tumors) criteria version 1.1. PFS is defined as the time from
    randomization to tumor progression or death from any cause.
    ORR = CR + PR measured by the RECIST 1.1 criteria

    Biological progression free interval defined by increasing CA 125
    levels (PFIBIO) (Gynecologic Cancer Intergroup [GCIG]:
    http://www.gcig.igcs.org/CA125/respdef_nov2005.pdf)

    Immunological response – detection of entire anti-tumor response
    (samples to be collected and frozen)
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS will be measured at the End of Study and the median PFS will be presented if at least 50% of patients progress.
    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 No
    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
    second line chemotherapy (paclitaxel, topotecan, liposomal doxorubicin)
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    last visit on the last subject enter
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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)
    None
    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 Decision2013-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-02
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