Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-001509-42
    Sponsor's Protocol Code Number:CA209-205
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-07-22
    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 number2014-001509-42
    A.3Full title of the trial
    Non-Comparative, Two-Cohort, Single Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in classical Hodgkin Lymphoma (cHL) Subjects after Failure of Autologous Stem Cell Transplant (ASCT)
    Estudio fase II no comparativo, de dos cohortes, de brazo único, abierto, de nivolumab (BMS-936558) en sujetos con linfoma de Hodgkin clásico (LHc) después del fracaso de trasplante autólogo de progenitores hematopoyéticos (TAPH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIB Study of Nivolumab in subjects with Hodgkin's Lymphoma (registrational)
    Estudio fase IIB de de nivolumab (BMS-936558) en sujetos con linfoma de Hodgkin clásico (LHc) después del fracaso de trasplante autólogo de progenitores hematopoyéticos (TAPH)
    A.3.2Name or abbreviated title of the trial where available
    CheckMate 205: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 205
    CheckMate 205: vía de control y evaluación en ensayos clínicos de nivolumab 205
    A.4.1Sponsor's protocol code numberCA209-205
    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 number900 150 160
    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 nameBMS936558
    D.3.9.4EV Substance CodeSUB32944
    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.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
    Hodgkin Disease
    Enfermedad de Hodgkin
    E.1.1.1Medical condition in easily understood language
    Hodgkin Disease
    Enfeermedad de Hodgkin
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level HLGT
    E.1.2Classification code 10025319
    E.1.2Term Lymphomas Hodgkin's disease
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    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 the clinical benefit of nivolumab, as measured by objective response rate (ORR) based on independent radiologic review committee (IRRC) assessment, and defined as proportion of subjects achieving either a partial remission (PR) or complete remission (CR).
    Evaluar el beneficio clínico de nivolumab, medido mediante la tasa de respuestas objetivas (TRO) basada en la evaluación por el comité de revisión radiológica independiente (CRRI) y definida como la proporción de sujetos que alcanzan una remisión parcial (RP) o una remisión completa (RC) según los criterios del International Working Group para Linfoma (Criterios 2007 del IWG) revisados.
    E.2.2Secondary objectives of the trial
    - Duration of response (DOR)
    - Complete remission (CR) rate and duration
    - Partial remission (PR) rate and duration
    - Investigator-assessed Objective Response Rate and Duration of Response
    Evaluar la duración de la respuesta objetiva (DRO) basada en las evaluaciones por el CRRI
    Evaluar la tasa de RC y la duración de la RC de acuerdo con la evaluación por el CRRI
    Evaluar la tasa de RP y la duración de la RP de acuerdo con la evaluación por el CRRI
    Evaluar la TRO y la DRO, de acuerdo con las evaluaciones por el investigador.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - ECOG performance status 0 or 1
    - Must have received prior high-dose conditioning chemotherapy followed by autologous stem cell transplant (ASCT) as a part of salvage therapy for cHL
    - Subjects may be brentuximab vedotin- naïve, or may have had prior brentuximab vedotin treatment as a salvage therapy after failure of ASCT
    - Estado funcional ECOG de 0 ó 1,
    - Deben haber recibido quimioterapia previa de acondicionamiento a dosis altas seguida por TAPH como parte de tratamiento de rescate para LHc
    - Los sujetos pueden ser naive al tratamiento con brentuximab vedotin o pueden haber recibido tratamiento previo con brentuximab vedotin que se administró después del fracaso del TAPH .
    E.4Principal exclusion criteria
    - Known central nervous system lymphoma
    - Subjects with nodular lymphocyte-predominant Hodgkin Lymphoma
    - Prior treatment history with brentuximab vedotin before ASCT
    - Prior allogeneic SCT
    - Chest radiation ? 24 weeks prior to first dose
    - Carmustine ? 600 mg/m² received as part of the pre-transplant conditioning regimen
    Linfoma conocido del sistema nervioso central.
    Sujetos con LH nodular de predominio linfocítico.
    Antecedentes de tratamiento previo con brentuximab vedotin administrado antes del primer TAPH.
    TAPH previo
    Radiación torácica ? 24 semanas antes de la primera dosis del medicamento del estudio.
    Carmustina (BCNU) ? 600 mg/m² recibida como parte de un régimen de acondicionamiento pretrasplante.
    E.5 End points
    E.5.1Primary end point(s)
    It is defined as the number of subjects with a best overall response (BOR) of CR or PR, according to the 2007 IWG criteria, based on Independent Radiographic Review Committee assessment, divided by the number of treated subjects.
    Se define como la proporción de sujetos que alcanzan la mejor respuesta global (MRG) de RP o RC según los criterios del International Working Group para Linfoma (Criterios 2007 del IWG) revisados, en base a la evaluación por el comité de revisión radiológica independiente (CRRI), dividido por el número de pacientes tratados.
    E.5.1.1Timepoint(s) of evaluation of this end point
    CT or MRI scans every 12 weeks
    TAC o RMI cada 12 semanas
    E.5.2Secondary end point(s)
    - Duration of response (DOR)
    - Complete remission (CR) rate and duration
    - Partial remission (PR) rate and duration
    - Investigator-assessed Objective Response Rate and Duration of Response
    Evaluar la duración de la respuesta objetiva (DRO) basada en las evaluaciones por el CRRI
    Evaluar la tasa de RC y la duración de la RC de acuerdo con la evaluación por el CRRI
    Evaluar la tasa de RP y la duración de la RP de acuerdo con la evaluación por el CRRI
    Evaluar la TRO y la DRO, de acuerdo con las evaluaciones por el investigador.
    E.5.2.1Timepoint(s) of evaluation of this end point
    CT or MRI scans every 12 weeks
    TAC o RMI cada 12 semanas
    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 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
    Biomarker Assessments, Outcomes Research Assessments, Immunogenicity Assessments
    Evaluaciones de biomarcador, evaluaciones de investigación de resultados, evaluaciones de inmunogenicidad.
    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.8.2.4Number 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Australia
    Austria
    Belgium
    Canada
    France
    Germany
    Italy
    Netherlands
    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
    Ultima visita de seguimiento del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 145
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 75
    F.4.2.2In the whole clinical trial 150
    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 study end subjects who continue to demonstrate clinical benefit and tolerating study drug will be eligible to receive it. Study drug will be provided via study extension, rollover study or another mechanism. BMS can terminate access to study drug if:a) marketing application rejected by responsible HA;b) study terminated due to safety concerns;c) subject can obtain medication from a government sponsored or private health program; or d) therapeutic alternatives become available in local market
    Al concluir el EC, los suj. que demuestren benef. clín. y toleren el medicamento serán elegibles para recibirle. El fármaco se facilitará mediante una ext. del estudio, un estudio de continuación u otro, a criterio de BMS. BMS se reserva el derecho de terminar el acceso si: la solicitud de comercializ. se rechaza; si se termina el estudio por problemas de seguridad; si el sujeto puede obtener la medicación por otro un programa del estado o privado; o si aparecen alternativas en el mercado local
    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 Decision2014-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-24
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 13:00:17 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA