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    Summary
    EudraCT Number:2013-003738-34
    Sponsor's Protocol Code Number:CA209-143
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-003738-34
    A.3Full title of the trial
    A Randomized Phase 2b, Open Label Study of Nivolumab or Nivolumab in Combination with Ipilimumab versus Bevacizumab in Adult Subjects with Recurrent Glioblastoma (GBM)
    Revised Protocol 01, incorporating Amendment 01
    Administrative Letter 01 version 1.0 dated 30-Jan-2014
    Estudio fase IIB, aleatorizado, abierto, de nivolumab o nivolumab en combinación con ipilimumab frente a bevacizumab en sujetos adultos con glioblastoma (GBM) recurrente.
    Protocolo revisado 01, que incorpora la enmienda 01.
    Carta administrativa 01, versión 1.0 de 30 de enero de 2014.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized Study of Nivolumab or Nivolumab combined with Ipilimumab versus Bevacizumab in Adult Subjects with Recurrent Glioblastoma (GBM)
    Estudio aleatorizado, abierto, de nivolumab o nivolumab en combinación con ipilimumab frente a bevacizumab en sujetos adultos con glioblastoma (GBM) recurrente.
    A.3.2Name or abbreviated title of the trial where available
    CheckMate143
    CheckMate 143: vía de control y evaluación en ensayos clínicos de nivolumab
    A.4.1Sponsor's protocol code numberCA209-143
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02017717
    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 pointEU Study Start-Up Unit
    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 number(+) 900 150 160
    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.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.3.1Product nameIpilimumab
    D.3.2Product code BMS-734016
    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 INNIPILIMUMAB
    D.3.9.1CAS number 477202-00-9
    D.3.9.2Current sponsor codeBMS-734016 / MDX010
    D.3.9.3Other descriptive nameBMS734016
    D.3.9.4EV Substance CodeSUB22577
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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) 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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 AVASTIN
    D.2.1.1.2Name of the Marketing Authorisation holderGenentech, Inc. (Roche Group)
    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 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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Recurrent glioblastoma
    Glioblastoma recurrente
    E.1.1.1Medical condition in easily understood language
    Recurrent glioblastoma
    Glioblastoma recurrente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of the study is to understand the safety, tolerability and efficacy of nivolumab as a single agent or in combination with ipilimumab versus bevacizumab in patients diagnosed with recurrent glioblastoma (GBM)
    El objetivo de este estudio es evaluar la seguridad, tolerabilidad y eficacia de nivolumab como agente único o en combinación con ipilimumab frente a bevacizumab en pacientes con glioblastoma recurrente diagnosticado.
    E.2.2Secondary objectives of the trial
    ? PFS
    ? ORR
    ? Comparing ORR between Nivolumab, or Nivolumab in combination with Ipilimumab versus Bevacizumab.
    Comparar la supervivencia libre de progresión (SLP) entre nivolumab o nivolumab en combinación con ipilimumab frente a bevacizumab
    Comparar la tasa de respuestas objetivas (TRO) entre nivolumab o nivolumab en combinación con ipilimumab y bevacizumab
    Comparar la supervivencia global de nivolumab en combinación con ipilimumab con la de nivolumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Subjects with histologically confirmed Grade IV malignant glioma
    ? Previous treatment with radiotherapy and temozolomide
    ? Documented first recurrence of GBM
    ? At least one measurable lesion
    ? Karnofsky PS ? 70
    b)Sujetos con diagnóstico confirmado histológicamente de glioma maligno de grado IV.
    c)Tratamiento previo de primera línea con al menos radioterapia y temozolamida
    d)Primera recidiva de GBM documentada .
    f)Al menos una lesión de GBM medible antes de la aleatorización,
    g)Estado funcional de Karnofsky de 70 o mayor
    E.4Principal exclusion criteria
    ? More than one recurrence of GBM.
    ? Presence of extracranial metastatic or leptomeningeal disease.
    ? Active, known or suspected autoimmune disease
    ? Prior bevacizumab or other VEGF or anti-angiogenic treatment
    ? Clinically significant cardiovascular disease
    a)Más de una recidiva de GBM
    b)Presencia de enfermedad metastásica extracraneal o enfermedad leptomeníngea
    c)Sujetos con enfermedad autoinmune activa, conocida o sospechada.
    d)Tratamiento previo con bevacizumab u otro tratamiento frente al VEGF o antiangiogénico
    e) Enfermedad cardiovascular clinicamrente significativa
    E.5 End points
    E.5.1Primary end point(s)
    Cohort 1 :Safety and tolerability based on drug related events leading to permanent discontinuation prior to completing 4 doses
    Cohort 2: Overall Survival (OS) - OS of Nivolumab, or Nivolumab in combination with Ipilimumab versus Bevacizumab. Overall Survival is defined as the time between the date of randomization and the date of death due to any cause
    Cohorte 1: Seguridad y tolerabilidad basada en eventos relacionados con el medicamento que conducen a la dinterrupción permanente del tratamiento antes de completar 4 dosis.
    Cohorte 2: Supervivencia global (SG). La supervivencia global de Nivolumab o Nivolumab en combinación con Ipilimumab frente a Bevacizumab. La SG se define como el tiempo desde la fecha de aleatorización hasta la fecha de la muerte por cualquier causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cohort 1: Approximately up to 8 months
    Cohort 2: After 176 death events
    Cohorte 1: Apróximadamente hasta 8 meses
    Cohorte 2: Después de 176 eventos de muerte
    E.5.2Secondary end point(s)
    ? PFS- Comparing PFS between Nivolumab, or Nivolumab in combination with Ipilimumab versus Bevacizumab. PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause
    ? ORR-Comparing ORR between Nivolumab, or Nivolumab in combination with Ipilimumab versus Bevacizumab. ORR is defined as the number of subjects whose best overall response (BOR) is complete response (CR) or partial response (PR) divided by all randomized subjects
    ? Comparing ORR between Nivolumab, or Nivolumab in combination with Ipilimumab versus Bevacizumab. Comparing OS between Nivolumab in combination with Ipilimumab versus Nivolumab
    ?SLP- Comparar la SLP entre Nivolumab, o Nivolumab en combinación con Ipilimumab versus Bevacizumab. La SLP se define como el tiempo desde la aleatorización hasta la fecha de la primera progresión tumoral documentada o muerte debida a cualquier causa
    ?TRO- Comparar la TRO entre Nivolumab, o Nivolumab en combinación con Ipilimumab versus Bevacizumab. La TRO se define como el número de sujetos cuya mejor respuesta global (MRG) sea respuesta completa (RC) o respuesta parcial (RP) dividida por todos los sujetos aleatorizados
    ? Comparar la SG Nivolumab, o Nivolumab en combinación con Ipilimumab versus Bevacizumab.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 176 death events
    Después de 176 eventos de muerte
    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 Yes
    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, Results of Central Radiologic Assessments
    Evluaciones de biomarcador, evaluaciones de investigación de resultados, evaluaciones de inmunogenicidad, resultados de evaluaciones radiológicas centrales.
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    Belgium
    Canada
    Denmark
    France
    Italy
    Netherlands
    Australia
    Finland
    Germany
    Spain
    Poland
    Switzerland
    United Kingdom
    United States
    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
    Last follow-up visit of the Last Subject
    Ültima 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 years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 302
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 117
    F.4.2.2In the whole clinical trial 377
    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 final del estudio, los sujetos que demuestren beneficio clínico serán elegibles para recibir el fármaco. Éste se facilitará mediante una extensión del estudio, estudio de continuación u otro mecanismo. BMS podrá terminar el acceso al fármaco si: a) la solic.de comercializ. se rechaza por las AASS responsables; b) se termmina el estudio por problemas de seguridad; c) si puede obtener la medicación de un progr.del estado o un progr. privado; o d) 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 Decision2014-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
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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
    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.

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