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    Summary
    EudraCT Number:2011-004967-65
    Sponsor's Protocol Code Number:SP004
    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:2011-11-02
    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 number2011-004967-65
    A.3Full title of the trial
    Randomized, open-label, parallel-group, multi-centre phase II clinical trial with active cellular immunotherapy DCVAC/PCa in patients with localized high-risk prostate cancer after primary radiotherapy
    Randomizovaná, otevřená, multicentrická klinická studie fáze II s paralelními skupinami u pacientů s lokalizovaným karcinomem prostaty vysokého rizika po primární radioterapii léčených pomocí aktivní buněčné imunoterapie DCVAC/PCa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, open-label, parallel-group, multi-centre phase II clinical trial with active cellular immunotherapy DCVAC/PCa in patients with localized high-risk prostate cancer after primary radiotherapy
    Randomizovaná, otevřená, multicentrická klinická studie fáze II s paralelními skupinami u pacientů s lokalizovaným karcinomem prostaty vysokého rizika po primární radioterapii léčených pomocí aktivní buněčné imunoterapie DCVAC/PCa
    A.3.2Name or abbreviated title of the trial where available
    not applicable
    A.4.1Sponsor's protocol code numberSP004
    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/ cityPraha 7 - Holešovice
    B.5.3.3Post code170 00
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420224175111
    B.5.5Fax number+420227204958
    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.3.9.2Current sponsor codeDCVAC/PCa
    D.3.9.3Other descriptive nameDCVAC/PCa
    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
    localized high-risk prostate cancer
    lokalizovaný karcinom prostaty s vysokým rizikem
    E.1.1.1Medical condition in easily understood language
    localized high-risk prostate cancer
    lokalizovaný karcinom prostaty s vysokým rizikem
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10071119
    E.1.2Term Hormone-dependent prostate 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The clinical trial’s objective is to estimate the survival rate of patients without PSA failure 5 years after randomization
    Cílem klinického hodnocení je odhad podílu přeživších pacientů bez PSA relapsu 5 let po randomizaci
    E.2.2Secondary objectives of the trial
    The clinical trial’s objective is to estimate the survival rate of patients without PSA failure, the survival rate of patients without initiation of salvage therapy 5 years after randomization, time to objective disease progression (time to Distant Failure - DF), overall survival and the incidence of adverse events.

    An exploratory objective is to search for potential biomarkers that could play a role as prognostic factors, indicate the biological effect of ACI on immuneresponse or identify a subgroup of patients profiting from cancer immunotherapy based on gene expression profiling.
    Cílem klinického hodnocení je odhad podílu přeživších pacientů bez PSA relapsu (viz 5.1), podílu přeživších pacientů bez zahájení „salvage“ terapie 5 let po randomizaci, doby do objektivní progrese onemocnění (čas do „Distant Failure“- DF), celkové přežití a četnost výskytu nežádoucích příhod.

    Cílem explorativních studií je definovat potenciální biomarkery, které by mohly hrát roli jako prognostické faktory, indikovat biologický vliv ACI na imunitní odpověď nebo umožnit identifikaci subpopulací pacientů profitujících z protinádorové imunoterapie (profilování na základě genové exprese).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I-1) Men aged ≥ 18 years
    I-2) Histologically confirmed localized high-risk or very high-risk prostate cancer meeting at least one of the following criteria: stage T3-T4 or Gleason Score 8 – 10 or PSA level higher than 20 ng/mL
    I-3) Indication for radical radiotherapy for prostate cancer
    I-4) The following laboratory values: WBC > 4 x 10(9)/L, platelet count > 100 x 10(9)/L, Hct > 30%, creatinine under 1.5 times the upper limit of normal, bilirubin, AST and ALT under two times the upper limit of normal
    I-5) Neoadjuvant androgen deprivation therapy for prostate cancer with LHRH analogs lasting at least 2 months and not initiated more than 12 months before randomization
    I-6) Indication for adjuvant androgen deprivation therapy
    I-7) ECOG 0-2 Performance Status
    I-8) Signed informed consent to participate in the study
    I-1) Muži ve věku ≥ 18 let
    I-2) Histologicky potvrzený lokalizovaný karcinom prostaty vysokého či velmi vysokého rizika splňující alespoň jedno z následujících: stadium T3-T4 nebo Gleason Score 8 – 10 nebo hladina PSA vyšší než 20 ng/ml
    I-3) Indikace k radikální radioterapii karcinomu prostaty
    I-4) Následující laboratorní hodnoty: WBC > 4 x 10(9)/l; trombocyty > 100 x 10(9)/l, Hct > 30%, kreatinin do 1,5 násobku horní hranice normy, bilirubin, AST a ALT do dvojnásobku horní hranice normy.
    I-5) Neoadjuvantní androgen deprivační terapie pro karcinom prostaty analogy LHRH probíhající nejméně 2 měsíce a zahájená ne déle než 12 měsíců před randomizací.
    I-6) Indikace k adjuvantní androgen deprivační terapii
    I-7) Performance Status podle ECOG 0-2
    I-8) Podepsaný informovaný souhlas s účastí ve studii
    E.4Principal exclusion criteria
    E-1) Sexually active fertile men not using effective birth control, if their partners are of fertile age and of child-bearing potential
    E-2) Comorbidities of the patient:
    E-2a) HIV-positive
    E-2b) Active hepatitis B or C
    E-2c) Active bacterial, viral or mycotic infection requiring systemic treatment
    E-2d) Clinically significant cardiovascular disease, including myocardial infarction or ventricular tachyarrhythmia in previous 6 months, percutaneous coronary intervention or surgical revascularization in the past 6 months, heart failure NYHA II-IV, known left ventricular dysfunction with ejection fraction < 40% or haemodynamically significant arrhythmias or conduction problems, unless treated with permanent cardiac pacing
    E-2e) Pleural or pericardial effusion of any CTC grade
    E-2f) Peripheral neuropathy CTC Grade ≥ 2
    E-2g) Other uncontrolled coexisting condition, uncompensated psychiatric illness or social situation that would limit the patient’s compliance
    E-2h) Patients with a history of malignancy other than non-melanoma skin cancer
    E-2i) Unresolved ongoing urinary tract obstruction
    E-2j) Active autoimmune disease requiring therapy
    E-2k) History of primary immunodeficiency
    E-3) Allergy and adverse drug reactions:
    E-3a) History of allergic reaction to a compound of the same or similar structure as the medication used in this study
    E-3b) History of anaphylaxis or other severe reaction following vaccination
    E-4) Any other reason the Investigator considers serious so that the patient should not participate in the study
    E-5) Primary surgical treatment for prostate cancer
    E-6) History of or ongoing chemotherapy for prostate cancer
    E-7) Participation in another clinical trial or administration of another investigational medicinal product within 30 days preceding the screening
    E-8) Immunotherapy other than specified in this protocol
    E-9) Presence of generalized metastatic disease
    E-1) Sexuálně aktivní fertilní muži neužívající efektivní kontrolu početí, pokud jsou jejich partnerky ve fertilním věku s možností otěhotnění
    E-2) Komorbidity pacienta:
    E-2a) Pozitivita HIV
    E-2b) Aktivní hepatitida B nebo C
    E-2c) Aktivní bakteriální, virová nebo mykotická infekce vyžadující systémovou léčbu
    E-2d) Klinicky signifikantní kardiovaskulární onemocnění včetně infarktu myokardu nebo komorové tachyarytmie v posledních 6 měsících, perkutánní koronární intervence nebo chirurgická revaskularizace v posledních 6 měsících, srdeční selhávání NYHA II-IV, známá dysfunkce levé komory s ejekční frakcí < 40% nebo hemodynamicky významné arytmie či poruchy převodu, pokud není zajištěno trvalou kardiostimulací.
    E-2e) Pleurální nebo perikardiální výpotek jakéhokoliv CTC stupně
    E-2f) Periferní neuropatie CTC stupně ≥ 2
    E-2g) Jiné nekontrolované přidružené onemocnění, nekompenzované psychiatrické onemocnění či sociální situace zhoršující spolupráci pacienta
    E-2h) Pacienti s prodělaným nádorovým onemocněním mimo nemelanomového nádoru kůže
    E-2i) Nevyřešená trvající obstrukce močového traktu
    E-2j) Aktivní autoimunitní onemocnění vyžadující terapii
    E-2k) Anamnéza primární imunodeficience
    E-3) Alergie a nežádoucí účinky
    E-3a) Anamnéza alergické reakce na sloučeninu stejné nebo podobné struktury jako medikace použitá v této studii
    E-3b) Anamnéza anafylaxe nebo jiné závažné reakce po vakcinaci
    E-4) Každý jiný závažný důvod, pro který by z pohledu zkoušejícího pacient neměl vestudii participovat
    E-5) Primární chirurgická léčba karcinomu prostaty
    E-6) Prodělaná nebo probíhající chemoterapie pro karcinom prostaty
    E-7) Účast v jiném klinickém hodnocení či podání jiného hodnoceného léčivého přípravku během 30 dnů před screeningem
    E-8) Imunoterapie jiná než specifikovaná tímto protokolem
    E-9) Přítomnost generalizovaného metastatického onemocnění
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the clinical trial is the survival rate of patients without PSA failure five years after randomization.
    Primární veličinou ve studii je podíl přeživších pacientů bez PSA relaps pět let po randomizaci.
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    E.5.2Secondary end point(s)
    The survival rate of patients without initiation of salvage therapy2 five years after randomization
    Incidence of adverse events
    The survival rate of patients without objective disease progression3 five years after randomization
    Overall survival

    Exploratory endpoints
    Immune response
    Gene expression profiling, and/or expression levels of pre-defined set of immune or cancer-related genes
    Podíl přeživších pacientů bez zahájení „salvage“ terapie2 pět let po randomizaci
    Četnost výskytu nežádoucích příhod
    Podíl přeživších pacientů bez objektivní progrese onemocnění3 pět let po randomizaci
    Celkové přežití

    Explorativní veličiny
    Imunitní odpověď
    Profilování na základě genové exprese a/nebo úrovně genové exprese u definované sady genů související s imunitou nebo s karcinomem
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 No
    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
    Patient group receiving only standard of care radiotherapy with androgen deprivation
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state60
    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 Decision2011-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-11
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