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    Summary
    EudraCT Number:2017-001431-39
    Sponsor's Protocol Code Number:TCD14906
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-06-07
    Trial 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2017-001431-39
    A.3Full title of the trial
    A Phase 1/2 study to evaluate safety, pharmacokinetics and efficacy of isatuximab in combination with REGN2810 in patients with relapsed/refractory multiple myeloma
    I/II. fázisú vizsgálat a REGN2810 készítménnyel kombinációban alkalmazott isatuximab biztonságosságának, farmakokinetikájának és hatásosságának értékelésére relabáló/kezelésre nem reagáló myeloma multiplexben szenvedő betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Isatuximab in Combination with REGN2810 in RRMM Patients
    A REGN2810 készítménnyel kombinációban alkalmazott isatuximab RRMM betegeknél
    A.4.1Sponsor's protocol code numberTCD14906
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1189-4706
    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 SponsorSanofi-aventis recherche & developpement
    B.1.3.4CountryFrance
    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 supportSanofi-aventis recherche & developpement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Zrt.
    B.5.2Functional name of contact pointNA
    B.5.3 Address:
    B.5.3.1Street AddressTó u . 1-5.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1045
    B.5.3.4CountryHungary
    B.5.6E-mailkapcsolat@sanofi.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1268
    D.3 Description of the IMP
    D.3.1Product nameisatuximab
    D.3.2Product code SAR650984
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNisatuximab
    D.3.9.2Current sponsor codeSAR650984
    D.3.9.3Other descriptive nameSAR650984
    D.3.9.4EV Substance CodeSUB119676
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    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.IMP: 2
    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.3.2Product code REGN2810
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.2Current sponsor codeREGN2810
    D.3.9.3Other descriptive nameAnti-PD-1 monoclonal antibody
    D.3.9.4EV Substance CodeSUB179369
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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
    Cancer
    Daganat
    E.1.1.1Medical condition in easily understood language
    Cancer
    Daganat
    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 10035226
    E.1.2Term Plasma cell myeloma
    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
    -To evaluate the safety and tolerability of the combination of Isatuximab (also known as
    SAR650984) and REGN2810 in patients with relapse/refractory multiple myeloma.

    -To evaluate the overall response rate of the combination of Isatuximab and REGN2810 in patients
    with RRMM.
    - Az isatuximab és a REGN2810 kombinációja biztonságosságának és tolerálhatóságának meghatározása relabáló/kezelésre nem reagáló myeloma multiplexben szenvedő (RRMM) betegeknél.

    - Az isatuximab és a REGN2810 kombináció összesített válaszarányának meghatározássa RRMM betegek körében.
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of response (DOR),
    time to response (TTR), progression free survival (PFS), and overall survival (OS).

    -To assess the pharmacokinetics (PK) of Isatuximab and REGN2810 when given in combination.

    -To assess the immunogenicity of isatuximab and REGN2810
    - A következő hatásossági mérőszámok meghatározása: a klinikai haszon aránya (CBR), a válasz időtartama (DOR), a válaszig eltelt idő (TTR), progressziómentes túlélés (PFS) és teljes túlélés (OS).

    - A kombinációban alkalmazott isatuximab és REGN2810 farmakokinetikai profiljának megállapítása.

    - A kombinációban alkalmazott isatuximab és REGN2810 immunogenitásának megállapítása.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients must have a known diagnosis of multiple myeloma with evidence of measurable disease, as defined below:
    -> Serum M-protein ≥1 g/dL (≥0.5 g/dL in case of IgA disease),
    AND/OR
    -> Urine M-protein ≥200 mg/24 hours,
    OR
    -> In the absence of measurable m-protein, serum immunoglobulin free light chain ≥10 mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio (<0.26 or >1.65).

    - Patients must have received prior treatment with an IMiD (for ≥2 cycles or ≥2 months of treatment) and a proteasome inhibitor (for ≥2 cycles or ≥2 months of treatment).

    - Patients must have received at least 3 prior lines of therapy (Note: Induction therapy and stem cell transplant ± maintenance will be considered as one line)
    OR
    - Patients whose disease is double refractory to an IMID and a PI (disease progression has occurred while on or within 60 days from end of the treatment).

    - Patient must have achieved MR or better with any anti-myeloma therapy (ie, primary refractory disease is not eligible).

    - Patients must have a disease that is refractory to the most recent prior line therapy (disease progression has occurred while on treatment or within 60 days from end of the treatment).
    -A betegnél ismerten myeloma multiplexet diagnosztizáltak, a mérhető betegség bizonyítékával, amelynek meghatározása:
    Szérum M-protein ≥1 g/dl (≥0,5 g/dl IgA betegségben),
    ÉS/VAGY
    Vizelet M-protein ≥200 mg/24 h,
    VAGY
    Ha nincs mérhető M-protein, a szérum immunglobulin szabad könnyű lánc ≥10 mg/dl, és rendellenes szérum kappa-lambda immunglobulin könnyűlánc-arány (<0,26 vagy >1,65)

    - A beteget korábban immunmódosító szerrel (IMiD) (a kezelés ≥2 ciklusig vagy ≥2 hónapig tartott) és proteaszóma-inhibitorral (PI) (a kezelés ≥2 ciklusig vagy ≥2 hónapig tartott) kezelték,

    - A beteg VAGY legalább 3 korábbi kezelést kapott (megjegyzés: az indukciós terápia és őssejt-transzplantáció ± fenntartás egy kezelésnek számít)
    VAGY
    A betegség kétszeresen nem reagáló immunmódosító szerre és egy proteaszóma-inhibitorra (a legutóbbi kezelés során vagy a befejezését követő 60 napon belül rosszabbodott a betegség).

    - A betegnek minimális vagy jobb választ kellett elérnie bármelyik myelomaellenes kezelés során (vagyis a primer nem reagáló betegséggel érintettek nem választhatók be).

    - A csak refrakter betegségben szenvedő betegek esetében, a betegség nem reagál a legutóbb alkalmazott kezelésre (a legutóbbi kezelés során vagy a befejezését követő 60 napon belül rosszabbodott a betegség).
    E.4Principal exclusion criteria
    - Prior exposure to isatuximab or participated clinical studies with isatuximab.
    - Prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1 pathway.
    - Evidence of other immune related disease /conditions.
    - History of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation.
    - Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
    - Has allogenic haemopoietic stem cell (HSC) transplant.
    - Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2.
    - Poor bone marrow reserve.
    - Poor organ function.
    - A beteg korábbi expozíciója isatuximabra, vagy részt vett az isatuximab klinikai vizsgálataiban,
    - A beteg korábbi expozíciója PD-1/PD-L1 útvonalat gátló bármely (engedélyezett vagy vizsgálati) hatóanyagra
    - Egyéb immunrendszeri betegségre/állapotra utaló bizonyíték
    - Szteroidkezelést szükségessé tevő nem fertőzéses eredetű pneumonia a kórelőzményben vagy fennálló pneumonia; mellkasi besugárzás a kórelőzményben
    - A beteg élővírus-vakcinát kapott a kezelés tervezett kezdete előtti 30 napon belül. Az élő vírust nem tartalmazó szezonális influenza-vakcinák megengedettek.
    - Allogén hemopoetikus őssejt- (HSC-) átültetést végeztek;
    - Az Eastern Cooperative Oncology Group (ECOG) teljesítménystátusz (PS) >2
    - Elégtelen csontvelő funkció
    - Elégtelen szervműködés
    E.5 End points
    E.5.1Primary end point(s)
    1 - Dose Limiting Toxicities (DLTs)
    DLTs are treatment-related adverse reactions in Cycle 1. Hematological DLT – Grade (G) 4 neutropenia >7 days; G 3 to 4 neutropenia with fever or documented infection; G 3 to 4 thrombocytopenia with bleeding requiring intervention. Non-hematological DLT - G 4 nonhematological AE; G ≥2 uveitis; G 3 non-hematological AE >3 days despite supportive care (with defined exceptions); Delay in initiation of the 2nd cycle >14 days for related laboratory abnormalities/AE. Other dose-limiting AE.

    2 - Adverse events (AEs) and changes in laboratory tests and vital signs
    Number of patients with AEs and changes in laboratory tests and vital signs according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 Grade scaling

    3 - Overall Response Rate (ORR)
    ORR is defined as the proportion of patients with complete response (CR) (including sCR [stringent complete response]), very good partial response (VGPR) and partial response (PR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 - Up to 4 weeks
    2 - Up to 30 days following the last administration of study treatment for ongoing related AE, ongoing serious AE and new related AE until resolution or stabilization
    3 - Up to 6 months from last patient in for primary efficacy analysis, and up to 12 months from last patient in (LPI) for the final analysis
    E.5.2Secondary end point(s)
    1 - Clinical Benefit Rate (CBR)
    CBR is defined as the proportion of patients with CR (including sCR), VGPR, PR and minimalresponse (MR)

    2 - Duration of Response (DOR)
    DOR is defined as the time from the date of the first response (≥PR) that is subsequently confirmed to the date of first confirmed disease progression or death, whichever happens first

    3 - Time to Response (TTR)
    TTR is defined as time from first study treatment administration to first response (≥PR) that is subsequently confirmed

    4 - Progression Free Survival (PFS)
    PFS is defined as time from the first study treatment administration to the date of first documentation of progressive disease that is subsequently confirmed or the date of death from any cause

    5 - Overall Survival (OS)
    OS defined as the time from the first study treatment administration to death from any cause

    6 - Assessment of PK parameter: partial AUC
    AUC is area under the drug concentration versus time curve

    7 - Assessment of PK parameter: Cmax
    Cmax is maximum drug concentration observed

    8 - Antibodies to isatuximab
    Levels of anti isatuximab antibodies in plasma samples will be determined

    9 - Antibodies to REGN2810
    Levels of anti REGN2810 antibodies in serum samples will be determined
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 to 4: Up to 6 months from last patient in for primary efficacy analysis, and up to 12 months from LPI for the final analysis
    5: Up to 12 months from LPI for the final analysis
    6 and 7: Up to 4 weeks
    8 and 9: Up to 12 months from LPI for the final analysis
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Canada
    France
    Hungary
    United States
    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
    LSLV
    utolsó beteg utolsó vizitje
    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 months1
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days13
    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: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 70
    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 Decision2017-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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