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    Summary
    EudraCT Number:2018-004467-31
    Sponsor's Protocol Code Number:DECENDO
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-13
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-004467-31
    A.3Full title of the trial
    An exploratory study: Dendritic cells for immunotherapy of metastatic endometrial cancer patients
    Immunotherapie met dendritische cellen bij patiënten met een uitgezaaide baarmoederkanker.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DC for endometrial cancer patients
    DC voor patiënten met baarmoederkanker
    A.3.2Name or abbreviated title of the trial where available
    DC for endometrial cancer patients
    DC voor patiënten met baarmoederkanker
    A.4.1Sponsor's protocol code numberDECENDO
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 nameAutologous tumor antigen peptide-, and KLH-loaded blood-derived natural dendritic cel
    D.3.2Product code ENDO-DC
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralymphatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeENDO-DC
    D.3.9.3Other descriptive nameautologous blood-derived dendritic cells loaded with tumor peptides
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5
    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) Yes
    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
    metastatic endometrial cancer
    Uitgezaaide baarmoeder kanker
    E.1.1.1Medical condition in easily understood language
    Patients with metastatic endometrial cancer
    Patiënten met een uitgezaaide baarmoederkanker
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    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 of this exploratory study is to show immunologic efficacy of tumor-peptide-loaded natural DC in mEC patients. The immune-monitoring will include: a) functional response and dextramer analysis of DTH infiltrating lymphocytes against tumor peptides, b) type I IFN gene expression in PBMC shortly after vaccination, and c) proliferative, effector cytokine- and humoral responses to keyhole limpet hemocyanin (KLH), an immunogenic protein providing T cell help.
    Het primaire doel van dit verkennende onderzoek is het aantonen van immunologische werkzaamheid van tumor-peptide-geladen natuurlijke DC in mEC-patiënten die chemotherapie ondergaan. De immuunbewaking omvat: a) functionele respons en dextramer-analyse van DTH-infiltrerende lymfocyten tegen tumorpeptiden, b) type I IFN-genexpressie in PBMC kort na vaccinatie, en c) proliferatieve, effector cytokine- en humorale responsen op hemodonine met sleutelgatzeeslak (KLH), een immunogeen eiwit dat hulp biedt aan T-cellen.
    E.2.2Secondary objectives of the trial
    The secondary objectives are the safety, feasibility and quality of life of natural DC vaccinations in combination with chemotherapy.
    De secundaire doelstellingen zijn de veiligheid, haalbaarheid en kwaliteit van leven van natuurlijke DC-vaccinaties in combinatie met chemotherapie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    women ≥ 18 years old with histologically confirmed stage IV or metastatic carcinoma of the endometrium of the endometroid, serous or carcinosarcoma type.
    • Hormone receptor negative or
    o resistant to hormonal therapy
    o ineligible for hormonal therapy because of other reasons
    • eligible for treatment with carboplatin paclitaxel combination chemotherapy
    • Life expectancy ≥ 6 months
    • WHO/ECOG performance status 0-1 (Karnofsky index 100-70)
    • WBC >2.0109/l, neutrophils >1.5109/L lymphocytes >0.8109/L, platelets >100109/L, hemoglobin >5,6 mmol/L (9.0 g/dL), serum creatinine <150 µmol/L, AST/ALT <3 x ULN, serum bilirubin <1.5 x ULN (exception: Gilbert’s syndrome is permitted)
    • Expression of survivin and/or muc1 on tumor material
    • Expected adequacy of follow-up
    • Postmenopausal or evidence of non-childbearing status or for women of childbearing potential: negative urine or serum pregnancy test, within 28 days of study treatment and confirmed prior to treatment on day 1
    • Written informed consent
    vrouwen 18 jaar en ouder met een histologisch bevestigd stadium IV of gemetastaseerd carcinoom van het endometrium van het endometroid, sereus of carcinosarcoma-type.
    • Hormoonreceptor negatief of
    o resistent tegen hormonale therapie
    o om andere redenen niet in aanmerking komen voor hormonale therapie
    • in aanmerking komt voor behandeling met carboplatine-combinatie met paclitaxelcombinatie
    • Levensverwachting ≥ 6 maanden
    • WHO / ECOG-prestatiestatus 0-1 (Karnofsky-index 100-70)
    • WBC> 2.0109 / l, neutrofielen> 1.5109 / L-lymfocyten> 0.8109 / L, bloedplaatjes> 100109 / L, hemoglobine> 5,6 mmol / L (9,0 g / dL), serumcreatinine < 150 μmol / L, AST / ALT <3 x ULN, serumbilirubine <1,5 x ULN (uitzondering: Gilbert-syndroom is toegestaan)
    • Expressie van survivin en/of muc1 op tumormateriaal
    • Verwachte adequaatheid van de follow-up
    • Postmenopauzaal of bewijs van niet-vruchtbare leeftijd of voor vrouwen in de vruchtbare leeftijd: negatieve urine- of serumzwangerschapstest, binnen 28 dagen na de onderzoeksbehandeling en bevestigd voorafgaand aan de behandeling op dag 1
    • Schriftelijke geïnformeerde toestemming
    E.4Principal exclusion criteria
    •Eligible for hormonal therapy
    •Uncontrolled hypercalcemia
    •History of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma
    •Known allergy to shell fish
    •Heart failure (NYHA class III/IV)
    •Serious active infections
    •Active hepatitis B, C or HIV infection
    •Active syphilis infection
    •Autoimmune diseases (exception: vitiligo is permitted)
    •Organ allografts
    •An uncontrolled co-morbidity, e.g. psychiatric or social conditions interfering which participation
    •Concurrent use of systemic corticosteroids > 10 mg daily prednisone equivalent
    •Any serious clinical condition that may interfere with the safe administration of DC vaccinations
    •Unable to undergo a tumor biopsy
    •Pregnancy or insufficient anti-conception if reproduction is still possible
    • In aanmerking komend voor hormonale therapie
    • Ongecontroleerde hypercalciëmie
    • Voorgeschiedenis van een tweede maligniteit in de afgelopen 5 jaar, met uitzondering van adequaat behandeld basaalcelcarcinoom
    • Bekende allergie voor schaaldieren
    • Hartfalen (NYHA klasse III / IV)
    • Ernstige actieve infecties
    • Actieve hepatitis B-, C- of HIV-infectie
    • Actieve syfilisinfectie
    • Auto-immuunziekten (uitzondering: vitiligo is toegestaan)
    • Orgaallotransplantaten
    • Een ongecontroleerde co-morbiditeit, b.v. psychiatrische of sociale omstandigheden die deelname verstoren
    • Gelijktijdig gebruik van systemische corticosteroïden> prednison-equivalent van 10 mg per dag
    • Elke ernstige klinische aandoening die het veilig toedienen van DC-vaccinaties kan verstoren
    • Kan geen tumorbiopsie ondergaan
    • Zwangerschap of onvoldoende anticonceptie als reproductie nog steeds mogelijk is
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is to evaluate the immune responses towards tumor peptide-loaded nDC in mEC patients. We will study: a) functional responses and tetramer analysis of DTH infiltrating lymphocytes against tumor peptides and b) type I IFN gene expression in PBMC shortly after vaccination, and c) proliferative, effector cytokine- and humoral responses.
    Het primaire eindpunt van de studie is om de immuunresponsen tegen tumorpeptide beladen nDC bij mEC-patiënten te evalueren. We bestuderen: a) functionele responsen en tetrameer-analyse van DTH infiltrerende lymfocyten tegen tumorpeptiden en b) type I IFN genexpressie in PBMC kort na vaccinatie, en c) proliferatieve, effector cytokine- en humorale responsen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After every round of vaccination, immunological response will be measured in DTH biopsies and in blood.
    Na elke vaccinatie ronde zal de afweer response gemeten worden in de biopten die genomen zijn van de DTH sites en in het bloed.
    E.5.2Secondary end point(s)
    The secondary objectives are the safety, feasibility and quality of life of nDC vaccinations in combination with chemotherapy.
    De secundaire doelstellingen zijn de veiligheid, haalbaarheid en kwaliteit van leven van natuurlijke DC-vaccinaties in combinatie met chemotherapie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Q of L before, after 3 vaccinations and end of study
    Q of L voor start studie, na 3 vaccinaties en bij het einde van de studie.
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    LVLS
    Laatste bezoek van de laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state8
    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
    geen
    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 Decision2019-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-01
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