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    Summary
    EudraCT Number:2013-001322-26
    Sponsor's Protocol Code Number:SOV01
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-23
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-001322-26
    A.3Full title of the trial
    A randomized, open-label, three-arm, multi-center Phase II clinical trial evaluating effect of addition of DCVAC/OvCa to first line standard chemotherapy (carboplatin and paclitaxel) in women with newly diagnosed epithelial ovarian carcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of efficacy and safety of DCVAC/OvCa (therapeutic ovarian cancer vaccine) in women with newly diagnoses ovarian cancer
    A.4.1Sponsor's protocol code numberSOV01
    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 Trials Sotio
    B.5.3 Address:
    B.5.3.1Street AddressJankovcova 1518/2
    B.5.3.2Town/ cityPrague 7
    B.5.3.3Post code170 000
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420224175111
    B.5.5Fax numberx
    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) 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
    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 20.0
    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 explore the effect of adding DCVAC/OvCa to Standard of Care chemotherapy on PFS measured at 2 years after randomization in women with ovarian cancer who have undergone debulking surgery
    E.2.2Secondary objectives of the trial
    •Proportion of patients staying in remission at 6 months after the last dose of first line chemotherapy
    •Proportion of patients staying in remission at 12 months after the last dose of first line chemotherapy
    •Biological progression free interval
    •Immunological response
    •Proportion of patients requiring second line chemotherapy
    •Time to second line chemotherapy
    •OS
    •Safety
    •Changes in quality of life (QoL)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female aged ≥18 years
    2. Patients with newly diagnosed, 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 surgery up to 3 weeks before randomization and are selected to receive first line Standard of Care chemotherapy (optional prolongation to 6 weeks after surgery)
    3. Optimally debulked (zero residuum) or maximal residuum <1cm
    4. Laboratory criteria:
    - White blood cells (WBC) >4,000/mm3 (4.0 x109/L)
    - Neutrophil count >1,500/mm3 (1.5 x109/L)
    - Hemoglobin (Hb) ≥10g/dL (100g/L)
    - Platelet count ≥100,000/mm3 (100 x109/L)
    - Total bilirubin within normal limits (benign hereditary hyperbilirubinemias, 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
    5. Adequate coagulation parameters
    - Activated partial thromboplastin time (APTT) ≤1.5x ULN and
    - International Normalized Ratio (INR) ≤ 1.5
    - Post-operative treatment with low molecular weight heparin (LMWH) is acceptable
    6. Life expectancy of at least 12 months based on Investigator’s judgment
    7. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
    8. Signed informed consent including patient’s ability to comprehend its contents
    9. Females of childbearing potential (assessed by Investigator) must have had a negative serum pregnancy test at screening (β human chorionic gonadotropin [β-HCG])
    E.4Principal exclusion criteria
    1. FIGO I,II,IV epithelial ovarian cancer
    2. FIGO III clear cells epithelial ovarian cancer
    3. Non-epithelial ovarian cancer, borderline tumors
    (tumors of low malignant potential)
    4. Post-surgery residual disease with lesion(s) >1cm
    5. Prior or current systemic anti-cancer therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy [bevacizumab], tyrosine kinase inhibitor therapy, vascular endothelial growth factor [VEGF] therapy or hormonal therapy)
    6. Previous or concurrent radiotherapy to the abdomen and pelvis
    7. Malignancy other than epithelial ovarian cancer, except those that have been in CR for a minimum of 3 years, or incidental low-grade carcinoid which has been totally extirpated during primary debulking surgery without signs of distant metastasis, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas
    8. 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:
    o Symptomatic congestive heart failure
    o Unstable angina pectoris
    o Serious cardiac arrhythmia requiring medication
    o Uncontrolled hypertension
    o 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
    - 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 of 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
    9. Known hypersensitivity to any constituent in the DCVAC/OvCa
    10. Systemic immunosuppressive therapy for any reason
    11. Refusal to sign the informed consent
    12. Participation in a clinical trial using experimental therapy within the last 4 weeks prior study entry
    13. Fertile woman of childbearing potential not willing to use highly effective method of contraception or combination of methods resulting into PEARL Index < 1 (implants, injectables, combination of oral contraceptives with intrauterine devices or barrier method of contraception or spermicidal jelly, vasectomized / sterilized partner or sexual abstinence) for the study duration and at least six months afterwards
    14. Pregnant or lactating women
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) measured at 2 years after randomization, where PFS is defined as time from randomization to documented disease progression, or death from any cause, whichever occurs earlier and where disease progression is defined as unequivocal progression of any existing lesions or appearance of any new lesion documented by computerized tomography (CT) or magnetic resonance imaging (MRI) scan. The median PFS will be presented if at least 50% of patients progress.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 2 years after randomization. The median of PFS will be presented if at least 50% of patients progress
    E.5.2Secondary end point(s)
    •Proportion of patients staying in remission at 6 months after the planned end of first line chemotherapy
    •Proportion of patients staying in remission at 12 months after the planned end of first line chemotherapy
    •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)
    •Proportion of patients requiring second line chemotherapy treatment
    •Time to second line therapy therapy (after the last dose of first line chemotherapy)
    •OS until End of Study (EOS). The OS for all randomized patients in this study will be analyzed 5 years after the randomization of the last patient in study part 2 or at least 50% maturity is reached, whichever occurs earlier.
    Adverse Events (AEs), including laboratory abnormalities
    Evaluation of QoL using standardized FACT-O (Functional Assessment of Cancer Therapy-Ovarian) questionnaire

    E.5.2.1Timepoint(s) of evaluation of this end point
    Proportion of patients staying in remission at 6 month after the planned end of first line chemotherapy
    Proportion of patients staying in remission at 12 months after the planned end of first line chemotherapy
    OS until End of Study (EOS).
    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
    first line chemotherapy (carboplatin plus paclitaxel)
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 end of the study is defined as a timepoint after a sufficient number of events have been observed to evaluate OS or after 5 years from the randomization of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 120
    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 Decision2013-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-11-18
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