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    Summary
    EudraCT Number:2013-003939-30
    Sponsor's Protocol Code Number:CA209-142
    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:2014-01-23
    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 number2013-003939-30
    A.3Full title of the trial
    A Phase 2 Clinical Trial of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Microsatellite High (MSI-H) Colon Cancer
    Ensayo clínico fase 2 con nivolumab y nivolumab más ipilimumab en cáncer de colon con alta inestabilidad de microsatélites (MSI H) recidivante y metastásico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Colon Cancer
    Ensayo clínico fase 2 con nivolumab y nivolumab más ipilimumab en cáncer de colon recidivante y metastásico.
    A.3.2Name or abbreviated title of the trial where available
    CheckMate 142
    CheckMate 142: vía de punto de control y evaluación en ensayos clínicos de nivolumab
    A.4.1Sponsor's protocol code numberCA209-142
    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.5.6E-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.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
    MSI Positive Colorectal Cancer
    MSI Negative Colorectal Cancer
    Cancer colorectal MSI positivo
    Cancer colorectal MSI negativo
    E.1.1.1Medical condition in easily understood language
    MSI Positive Colorectal Cancer
    MSI Negative Colorectal Cancer
    Cancer colorectal MSI positivo
    Cancer colorectal MSI negativo
    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 10061451
    E.1.2Term Colorectal cancer
    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
    The purpose of this study is to examine if nivolumab alone or in combination with ipilimumab will demonstrate a meaningful objective response rate in patients with recurrent and metastatic colon cancer who also have a specific biomarker in their tumors.
    Evaluar la tasa de respuestas objetivas (TRO) a nivolumab en monoterapia o nivolumab combinado con ipilimumab en sujetos con cáncer de colon recidivante o MSI H metastásico que también tienen un biomarcador específico en sus tumores.
    E.2.2Secondary objectives of the trial
    To evaluate the IRRC objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with metastatic MSI-H CRC
    Evaluar la tasa de respuestas objetivas (TRO) a nivolumab en monoterapia o nivolumab combinado con ipilimumab en sujetos con cáncer de colon recidivante o MSI H metastásico.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    CA209142 will also contain a safety cohort of subjects with non-Microsatellite Instability-High Colorectal Cancer to assess the safety and tolerability of nivolumab in combination with ipilimumab in subjects with non-Microsatellite Instability-High Colorectal Cancer in preparation for an analogous 2 stage assessment of the response rate for the combination in Microsatellite Instability-High Colorectal Cancer. See also protocol, section 3.1 (same version and date as the protocol).

    Approximately 10 subjects with recurrent or metastatic nMSI-H CRC will be randomized (1:1) to Dose Level 2a and Dose Level 2b.
    El estudio CA209142 contendrá también una cohorte de seguridad de sujetos con cáncer de colon no MSI H para evaluar la seguridad y tolerabilidad de nivolumab en combinación con ipilimumab en sujetos con cáncer de colon no MSI H en preparación para una evaluación análoga de 2 etapas de la tasa de respuesta de la combinación en el CRC MSI H. Ver también la sección 3.1 del protocolo ( misma versioón y fecha del protocolo).
    Aproximadamente 10 sujetos con MSI-H CCR recidivante o metastásico serán randomizados (1:1) al nivel de dosis 2a y nivel de dosis 2b.
    E.3Principal inclusion criteria
    ?Men and women ? 18 years of age
    ?ECOG performance status 0 to 1.
    ?Histologically confirmed colorectal cancer.
    ?Measurable disease by CT or MRI.
    ?Testing for MSI Status
    ?Adequate organ function as defined by study-specific laboratory tests
    ?Must use acceptable form of birth control throughout the study. After the final dose of study drug, an acceptable form of birth control must be used for 23 weeks for women of childbearing potential (WOCBP) and 31 weeks for men who are sexually active with WOCBP.
    ?Signed informed consent
    ?Willing and able to comply with study procedures
    Varones y mujeres ? 18 de años
    Estado funcional del ECOG de 0 1
    CRC confirmado histológicamente
    Los sujetos deben tener enfermedad medible por TC o RM
    Testing por estatus MSI
    Las mujeres potencialmente fértiles deben estar de acuerdo en seguir las instrucciones sobre métodos anticonceptivos desde el momento del reclutamiento, durante todo el tratamiento del estudio y hasta 23 semanas después para las mujeres potencialmente fertiles (WOCBP) y hasta 31 semanas para aquellas sexualmente activas y potencialmente fértiles.
    Función orgánica adecuada definida por pruebas de laboratorio específicas ara este ensayo.
    Consentimiento informado por escrito firmado
    Deseo y capacidad para cumplir con los procedimientos del estudio.
    E.4Principal exclusion criteria
    ?Active brain metastases or leptomeningeal metastases are not allowed.
    ?Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
    ?Prior malignancy active within the previous 3 years except for locally curable cancers
    ?Subjects with active, known or suspected autoimmune disease.
    ?Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
    No se permiten las metástasis cerebrales activas o las metástasis leptomeníngeas.
    Tratamiento previo con un anticuerpo anti PD 1, anti PD L1, anti PD L2, anti CTLA 4 o cualquier otro anticuerpo o fármaco dirigido específicamente a las vías de coestimulación de los linfocitos T o el punto de control inmunitario.
    Neoplasia maligna activa previa dentro de los 3 años previos excepto cánceres curables localmente
    Sujetos con enfermedad autoinmunitaria activa, conocida o sospechada.
    Sujetos con un problema que exija tratamiento sistémico con corticosteroides (> 10 mg de prednisona al día o equivalente) u otros medicamentos inmunosupresores dentro de los 14 días previos a la administración del fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is objective response rate (ORR) in all MSI-H subjects as determined by investigators.
    El objetivo principal es la tasa de respuestas objetivas (TRO) en sujetos con cáncer de colon recidivante o MSI H metastásico como sea determinado por los investigadores.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final analysis of the primary endpoint will occur at least 6 months after the last enrolled subject?s first dose of study therapy.
    El análisis final del objetivo principal tendrá lugar a los 6 meses depués de la primera dosis de tratamiento del ultimo paciente del estudio.
    E.5.2Secondary end point(s)
    The secondary endpoint is ORR in all MSI-H subjects based on IRRC determination.
    El objetivo secundario es la tasa de respuestas objetivas (TRO) observadas por el CRRI en sujetos con CRC MSI H metastásico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The final analysis of the secondary endpoint will occur at the time of the primary endpoint analysis.
    El análisis final del objetivo secundario se realizará al mismo tiempo que el análisis del objetivo primario.
    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
    Evaluaciones de biomarcador, evaluaciones de investigación de resultados
    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 1b to examine a tolerable dose in subjects with colon cancer
    fase 1b para examinar una dosis tolerable en sujetos con cancer colorectal
    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 trial2
    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 EEA10
    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
    France
    Ireland
    Norway
    Australia
    Finland
    Spain
    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 Subject
    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 years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days20
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 69
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 115
    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 study drug up to 12 months after the approval of study drug by the responsible health authority or until the study drug becomes commercially available within the country, whichever occurs sooner. See protocol section 3.2 for more details.
    A la conclusión del estudio, los sujetos que sigan demostrando beneficio clínico serán elegibles para recibir el fármaco del estudio hasta 12 meses después de la aprobación del fármaco del estudio por parte de las autoridades sanitarias responsables o hasta que el fármaco del estudio pase a estar disponible comercialmente dentro del país, lo que suceda antes. Ver la sección 3.2 del protocolo para más detalles.
    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 Decision2014-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-05
    P. End of Trial
    P.End of Trial StatusOngoing
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