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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-003286-28
    Sponsor's Protocol Code Number:CA209-436
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-02-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-003286-28
    A.3Full title of the trial
    A Phase I/ II Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab in Combination with Brentuximab Vedotin in Subjects with Relapsed Refractory Non Hodgkin Lymphomas with CD30 Expression
    Estudio fase I/II para evaluar la seguridad y la eficacia preliminar de nivolumab en combinación con brentuximab vedotin en sujetos con linfomas no Hodgkin con expresión de CD30 en recidiva y refractario (CheckMate 436: ensayos clínicos de evaluación de nivolumab y vías de punto de control).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety and Efficacy Study of Nivolumab in Combination with Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas
    Estudio para evaluar la seguridad y la eficacia de nivolumab en combinación con brentuximab vedotin en sujetos con linfomas no Hodgkin
    A.3.2Name or abbreviated title of the trial where available
    CheckMate 436: CHECKpoint pathway and nivolumab clinical Trail Evaluation
    CheckMate 436: vía de control y evaluación en ensayos clínicos de nivolumab
    A.4.1Sponsor's protocol code numberCA209-436
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02581631
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1172-4988
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number900150160
    B.5.6E-mailclinical.trials@bms.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 nameNIVOLUMAB
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Solution for injection/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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558-01
    D.3.9.3Other descriptive nameBMS-936558, MDX1106, ONO-4538
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.2.1.1.1Trade name ADCETRIS
    D.2.1.1.2Name of the Marketing Authorisation holderSeattle Genetics
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Powder for 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 INNBRENTUXIMAB VEDOTIN
    D.3.9.1CAS number 914088-09-8
    D.3.9.3Other descriptive nameBRENTUXIMAB VEDOTIN
    D.3.9.4EV Substance CodeSUB32397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    Relapsed Refractory Non Hodgkin Lymphomas with CD30 Expression
    Linfomas no Hodgkin con expresión de CD30 en recidiva y refractario
    E.1.1.1Medical condition in easily understood language
    Non-Hodgkin Lymphomas
    Linfomas no Hodgkin
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLT
    E.1.2Classification code 10029606
    E.1.2Term Non-Hodgkin's lymphomas transformed recurrent
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to assess whether nivolumab in combination with brentuximab vedotin is safe and effective in certain subtypes of non-hodgkin lymphomas
    Evaluar la seguridad y eficacia de la combinación de nivolumab y brentuximab en ciertos subtipos de linfomas no Hodgkin
    E.2.2Secondary objectives of the trial
    - Assess the overall duration of response (DOR)
    - Assess the complete response rate (CRR) and duration
    - Progression-Free Survival (PFS)
    - Overall Survival (OS)
    - Evaluar la duración de la respuesta (DdR) global
    - Evaluar la TRC con el régimen de combinación y la duración de la RC
    - Evaluar la SLP de acuerdo con las evaluaciones por los investigadores y
    - Evaluar la SG del régimen de combinación de brentuximab vedotin y nivolumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Relapsed/refractory Diffuse Large B
    Cell Lymphoma (DLBCL),
    relapsed/refractory Peripheral T
    Cell Lymphoma (PTCL) (all subtypes
    excluding Anaplastic Large Cell
    Lymphoma) and relapsed/refractory
    Cutaneous T Cell Lymphoma (CTCL)
    Mycosis Fungoides/Sezary Syndrome (MF/SS)
    Expression of CD30
    Subjects must be 18 years or older
    - Diagnóstico de LDCBG en recidiva/refractario
    - LCTP en recidiva/refractario (excepto LACG) y LCCT en recidiva/refractario (MF/SS)
    - linfoma cutáneo de células T en recidiva/refractario
    - Micosis fungoides y síndrome de Sézary
    - expresión confirmada de CD30
    - Sujetos deben ser mayores de 18 años
    E.4Principal exclusion criteria
    Known central nervous system (CNS)
    lymphomas; Active
    cerebral/meningeal disease related
    to the underlying malignancy
    Active, known, or suspected autoimmune disease
    - Linfomas conocidos en el Sistema Nervioso Central (SNC)
    - sujetos con enfermedades cerebrales o meníngeas relacionadas con una malignidad subyacentes
    - Sospecha o enfermedad confirmada autoinmune
    E.5 End points
    E.5.1Primary end point(s)
    - Safety and tolerability of the combination of nivolumab and brentuximab vedotin in subjects with diagnosis of DLBCL, PTCL, CTCL
    - Assess the clinical benefit of nivolumab and brentuximab vedotin combination regimen in subjects as measured by Overall Response Rate (ORR)
    - Evaluar la seguridad y tolerabilidad de la combinación de nivolumab y brentuximab en sujetos con diagnóstico de LDCBG, LCTP y LCCT
    - Evaluar el beneficio clínico del régimen de combinación de nivolumab y brentuximab vedotin mediante la Tasa de Respuesta objetiva
    E.5.1.1Timepoint(s) of evaluation of this end point
    - First dose to up to 100 days after the last dose of study treatment
    - 8 months after the last patient receives their first dose
    - Desde la primera dosis hasta 100 días después del último tratamiento
    - 8 meses después de que el último paciente recibe su primera dosis
    E.5.2Secondary end point(s)
    - Assess the overall duration of response (DOR)
    - Assess the complete response rate (CRR) and duration
    - Progression-Free Survival (PFS)
    - Overall Survival (OS)
    - Evaluar la duración de la respuesta (DdR) global
    - Evaluar la TRC con el régimen de combinación y la duración de la RC
    - Evaluar la SLP de acuerdo con las evaluaciones por los investigadores
    - Evaluar la SG del régimen de combinación de brentuximab vedotin y nivolumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 8 months after the last patient receives their first dose
    - 8 months after the last patient receives their first dose
    - 8 months after the last patient receives their first dose
    - 1 year after the first patient receives their first dose
    - 8 meses después de que el último paciente recibe su primera dosis
    - 8 meses después de que el último paciente recibe su primera dosis
    - 8 meses después de que el último paciente recibe su primera dosis
    - 1 año después de que el primer paciente recibe su primera dosis
    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 Yes
    E.6.13.1Other scope of the trial description
    Exploratory biomaker objectives, outcomes research and immunogenicity
    Evaluaciones de investigación de resultados, evaluaciones de inmunogenicidad y evaluaciones de biomarcadores
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I/II, the combination of nivolumab and brentuximab is evaluated
    Estudio fase I/II de nivolumab en combinación con brentuximab vedotin
    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 No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Italy
    Spain
    United Kingdom
    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
    Last follow-up visit of the last patient
    Última visita de seguimiento del último paciente
    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 months7
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    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)
    At the conclusion of the study, subjects who continue to demonstrate clinical benefit will be eligible to receive BMS supplied study drug (brentuximab vedotin and nivolumab). Study drug will be provided via an extension of the study, a rollover study requiring approval by responsible health authority and ethics committee or through another mechanism at the discretion of BMS.
    Cuando concluya el EC, los sujetos que sigan demostrando beneficio clínico serán elegibles para recibir el medicamento dado por BMS. Dicho medicamento se facilitará mediante una extensión del EC, un EC de continuación que requiriendo la aprobación de la autoridad sanitaria y Comité Ético competentes u otro mecanismo según el criterio de BMS.
    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 Decision2016-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-02-07
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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