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    Summary
    EudraCT Number:2012-002814-38
    Sponsor's Protocol Code Number:SP005
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-30
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2012-002814-38
    A.3Full title of the trial
    A Randomized, Double Blind, Multicenter, Parallel-group, Phase III study to evaluate efficacy and safety of DCVAC/PCa versus Placebo in Men with metastatic Castration Resistant Prostate Cancer eligible for 1st line chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of efficacy and safety of DCVAC/PCa (therapeutic prostate cancer immunotheraphy) against placebo in men with metastatic prostate cancer eligible for chemotherapy
    A.3.2Name or abbreviated title of the trial where available
    VIABLE
    A.4.1Sponsor's protocol code numberSP005
    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 00
    B.5.3.4CountryCzech Republic
    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/PCa
    D.3.2Product code DCVAC/PCa
    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/PCa
    D.3.9.1CAS number DCVAC/PCa
    D.3.9.2Current sponsor codeDCVAC/PCa
    D.3.9.3Other descriptive nameCELL SUSPENSION CONTAINING DENDRITIC CELLS
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    metastatic castrate-resistant prostate cancer
    E.1.1.1Medical condition in easily understood language
    metastatic castrate-resistant prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    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
    The primary objective is to show superiority of treatment with DCVAC/PCa in addition to Standard of Care (docetaxel plus prednisone) over placebo in addition to Standard of Care (docetaxel plus prednisone) in men with mCRPC as measured by overall survival (OS).
    E.2.2Secondary objectives of the trial
    Key Secondary:
    The key secondary objectives include assessments of safety, treatment group comparison with regards to radiographic progression free survival, time to prostate-specific antigen progression, time to first occurrence of skeletal related events (SRE).

    Other Secondary:
    Show clinical benefit of treatment with DCVAC/PCa in addition to SOC over Placebo in addition to SOC with regard to time to radiographic progression or to skeletal related events and proportion of patients with SRE.

    Exploratory Objective:
    Treatment group comparison for the following measures: Proportion of subjects requiring second line treatment introduction and time to second line therapy, changes in quality of life (QoL) and exploratory studies for search of potential biomarkers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male 18 years and older.
    •Histologically or cytologically confirmed prostate adenocarcinoma.
    •Presence of skeletal and/or soft-tissue/visceral/nodal metastases according to one of the following criteria:
    Confirmed pathological fracture related to the disease.
    OR
    Confirmation of distant bone and/or soft-tissue and/or visceral metastases through at least one imaging modality including CT or MRI or scintigraphy scan. (confirmation by independent review facility (IRF) required)
    OR
    Positive pathology report of metastatic lesion.
    •Disease progression despite androgen deprivation therapy (ADT) as indicated by:
    PSA increase that is ≥ 25% and ≥ 2 ng/mL above the minimum PSA as reached during ADT or above the pre-treatment level, if no response was observed and which is confirmed by a second value 1 or more weeks later.
    OR
    Progression of measurable lymph nodes (short axis ≥ 15mm) or visceral lesion measurable per RECIST v1.1 criteria (confirmation by IRF required);
    OR
    Two or more new lesions appearing on bone scan/imaging compared with a previous scan (confirmation by IRF required)
    •Maintenance of castrate conditions: Subjects, who have not had a surgical orchiectomy, must continue with hormone therapy (GnRH/LHRH agonists or antagonists) to reach levels of serum testosterone of ≤1.7nmol/l (50ng/dl). The duration of the castration period must be at least 4 months before screening.
    •Laboratory criteria:
    White blood cells greater than 4,000/mm(3) (4.0 x10(9)/L).
    Neutrophil count greater than 1,500/mm(3) (1.5 x10(9)/L).
    Hemoglobin of at least 10 g/dL (100g/L).
    Platelet count of at least 100,000/mm(3) (100 x10(9)/L).
    Total bilirubin within normal limits (benign hereditary hyperbilirubinaemias, e.g. Gilbert´s syndrome are permitted).
    Serum alanine aminotransferase and aspartate aminotransferase, and creatinine <1.5 times the ULN.
    •Life expectancy of at least 6 months based on Investigator´s judgment.
    •Eastern Cooperative Oncology group (ECOG) Performance status 0-2.
    •At least 4 weeks after surgery or radiotherapy before randomization.
    •A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy before randomization.
    •Recovery from primary local surgical treatment, radiotherapy or orchiectomy before randomization.
    •Signed informed consent including patient’s ability to comprehend its contents
    E.4Principal exclusion criteria
    •Confirmed brain and/or leptomeningeal metastases
    (other visceral metastases are acceptable).
    •Current symptomatic spinal cord compression requiring surgery or radiation therapy.
    •Prior chemotherapy for prostate cancer
    •Patient co-morbidities:
    Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone).
    HIV positive, 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 screening, known left ventricular ejection fraction (LVEF) <40% or serious cardiac conduction system disorders, if a pacemaker is not present.
    Pleural and pericardial effusion of any CTCAE grade.
    Peripheral neuropathy having a CTCAE ≥grade 2.
    History of active malignant disease (with the exception of non-melanoma skin tumors) in the preceding five years.
    Active autoimmune disease requiring treatment.
    History of severe forms of primary immune deficiencies.
    History or anaphylaxis or other serious reaction following vaccination.
    Known hypersensitivity to any constituent in of the DCVAC/PCa or placebo product
    Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator’s opinion, would prevent participation in the trial.
    •Systemic corticosteroids at doses greater than 40mg hydrocortisone daily or equivalent for any reason other than treatment of prostate cancer (PCa) within 6 months before randomization.
    •Ongoing Systemic immunosuppressive therapy for any reason.
    •Treatment with anti-androgens, inhibitors of adrenal-produced androgens or other hormonal tumor-focused treatment performed on the day of randomization (except for GnRH/LHRH agonists or antagonists), to exclude possible anti-androgen withdrawal response. This criterion does not apply to subjects, who have never responded to anti-androgen treatment as there is no risk of anti-androgen withdrawal response.
    •Treatment with immunotherapy against PCa within 6 months before randomization.
    •Treatment with radiopharmaceutical within 8 weeks before randomization.
    •Participation in a clinical trial using experimental therapy within 4 weeks before randomization.
    •Participation in a clinical trial using immunological experimental therapy (e.g. monoclonal antibodies, cytokines or active cellular immunotherapies) within 6 months before randomization.
    •Refusal to sign the informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    E.5.2Secondary end point(s)
    Key Secondary efficacy endpoints:
    •Radiological progression free survival (rPFS), composite of
    radiographic progression of bone lesions
    radiographic progression of soft tissue lesions
    death due to any cause
    •Time to prostate-specific antigen (PSA) progression
    •Time to first skeletal related events (SRE)

    Other Secondary efficacy endpoints:
    •Time to radiographic progression or SRE
    •Proportion of patients with SRE

    Safety endpoints:
    Adverse events, including laboratory abnormalities, change in vital signs and change in ECOG performance status.

    Exloratory endpoints:
    •Evaluation of QoL using standardized FACT-P questionnaire
    •Proportion of subjects requiring second line treatment introduction
    and time to second line therapy.
    •Exploratory studies for search of potential biomarkers
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 Yes
    E.8.2.3Other No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA200
    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
    Austria
    Belarus
    Belgium
    Bulgaria
    Croatia
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Italy
    Latvia
    Lithuania
    Netherlands
    Poland
    Portugal
    Serbia
    Slovakia
    Spain
    Sweden
    United Kingdom
    United States
    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
    Total study duration of approximately 40 months to observe the required event-driven timeframe of 657 total events for the final analysis. If the anticipated 657 events are not attained during the trial timeline, the study could be prolonged by SOTIO.
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 670
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 850
    F.4.2.2In the whole clinical trial 1170
    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)
    not applicable
    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 Decision2015-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-28
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