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    Summary
    EudraCT Number:2021-000039-29
    Sponsor's Protocol Code Number:CA020-016
    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:2021-08-31
    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 number2021-000039-29
    A.3Full title of the trial
    A Phase 2 Randomized Double-blind Study of BMS-986207 in Combination with Nivolumab and Ipilimumab as First-line Treatment for Participants with Stage IV Non-Small Cell Lung Cancer
    Estudio en fase II, aleatorizado, doble ciego de BMS-986207 en combinación con nivolumab e ipilimumab como tratamiento de primera
    línea para participantes con cáncer de pulmón no microcítico en estadio IV.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of BMS-986207 in Combination with Nivolumab and Ipilimumab in Participants with Stage IV NSCLC
    Estudio de BMS-986207 en combinación con nivolumab e ipilimumab en participantes con CPNM en estadio IV.
    A.4.1Sponsor's protocol code numberCA020-016
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1263-4850
    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 pointGSM-CT
    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 nameBMS-986207
    D.3.2Product code BMS-986207
    D.3.4Pharmaceutical form Lyophilisate 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 INNBMS-986207
    D.3.9.2Current sponsor codeBMS-986207
    D.3.9.3Other descriptive nameBMS986207, BMS-986207, BMS-986207-01, Anti-TIGIT mAb
    D.3.9.4EV Substance CodeSUB184190
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 Opdivo (100 mg/10 ml)
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 - 10mL vial COMMERCIAL
    D.3.2Product code BMS-936558
    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 INNnivolumab
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive nameBMS936558, BMS-936558, MDX1106, ONO-4538)
    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: 3
    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
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Small Cell Lung Cancer
    Cáncer de pulmón no microcítico
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    Cáncer de pulmón
    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 LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety, tolerability, and DLTs of BMS-986207 in combination with nivolumab plus ipilimumab in participants with 1L Stage IV NSCLC (Part 1)

    To compare the PFS of BMS-986207 in combination with nivolumab plus ipilimumab (Arm A) versus nivolumab plus ipilimumab (Arm B) in participants with 1L Stage IV NSCLC expressing PD-L1 (Part 2)
    Evaluar la seguridad, la tolerabilidad y las toxicidades limitantes de la dosis (TLD) de BMS-986207 en combinación con nivolumab más ipilimumab en participantes con CPNM en estadio IV en 1L en la preinclusión de seguridad (parte 1).

    Evaluar la seguridad, la tolerabilidad y las toxicidades limitantes de la dosis (TLD) de BMS-986207 en combinación con nivolumab más ipilimumab en participantes con CPNM en estadio IV en 1L en la preinclusión de seguridad (parte 1)
    E.2.2Secondary objectives of the trial
    PFS of BMS-986207 in combination with nivolumab plus ipilimumab (Arm A) versus nivolumab plus ipilimumab (Arm B) in randomized participants and in subgroups defined by PD-L1 expression

    Safety and tolerability of BMS-986207 in combination with nivolumab plus ipilimumab (Arm A) and nivolumab plus ipilimumab (Arm B) in participants with 1L Stage IV NSCLC (Part 2)

    ORR and DOR of BMS-986207 in combination with nivolumab plus ipilimumab (Arm A) and nivolumab plus ipilimumab (Arm B) in randomized participants and in subgroups defined by PD-L1 expression

    OS of BMS-986207 in combination with nivolumab plus ipilimumab (Arm A) versus nivolumab plus ipilimumab (Arm B) in randomized participants and in subgroups defined by PD-L1 expression
    Comparar la SSP de BMS-986207 en combinación con nivolumab más ipilimumab (grupo A) frente a nivolumab más ipilimumab (grupo B) en todos los participantes aleatorizados con CPNM en estadio IV en 1L.

    Evaluar la seguridad y la tolerabilidad de BMS-986207 en combinación con nivolumab más ipilimumab (grupo A) y de nivolumab más ipilimumab (grupo B) en participantes con CPNM en estadio IV en 1L (parte 2).

    Calcular la tasa de respuesta objetiva (TRO) de BMS-986207 en combinación con nivolumab más ipilimumab (grupo A) y nivolumab más ipilimumab (grupo B) en todos los participantes aleatorizados con CPNM en estadio IV en 1L y en subgrupos definidos por la expresión de PD-L1.

    Comparar la supervivencia global (SG) de BMS-986207 en combinación con nivolumab más ipilimumab (grupo A) frente a nivolumab más ipilimumab (grupo B) en los participantes aleatorizados con tumores con expresión de PD-L1 ≥1 %
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males and females; ≥ 18 years of age or local age of majority.
    Histologically confirmed metastatic 1L Stage IV NSCLC of squamous or nonsquamous histology
    No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic NSCLC
    Measureable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
    Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    Participants must have a life expectancy of at least 3 months at the time of first dose.
    A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor tissue obtained during screening or prior to enrollment (within 3 months of enrollment and with no intervening systemic anticancer treatment between time of acquisition and enrollment). Samples must be sent to central laboratory and confirmed to be evaluable prior to treatment assignment or randomization.
    Assessment of tumor-cell PD-L1 expression by immunohistochemistry must be performed by central laboratory using pre-treatment tissue sample, and results must be reported prior to randomization (Part 2).
    CPNM metastásico en estadio IV en 1L histológicamente confirmado de histología epidermoide o no epidermoide.
    No se ha administrado ningún tratamiento antineoplásico sistémico previo como tratamiento principal para el CPNM avanzado o metastásico.
    Enfermedad medible según los criterios de evaluación de la respuesta al tratamiento en tumores sólidos (RECIST) v1.1.
    Estado funcional de 0-1 según el Grupo Oncológico Cooperativo de la Costa Este (ECOG).
    Antes de la aleatorización, se debe enviar al laboratorio central un bloque de tejido tumoral fijado en formol e incluido en parafina (FFIP), (preferible, equivalente a 20 cortes) o un mínimo de 20 portaobjetos no teñidos de tejido tumoral obtenidos durante la selección o antes de la inscripción (en el plazo de 3 meses a partir de la inscripción y sin que intervenga un tratamiento antineoplásico sistémico entre el momento de la adquisición y la inscripción). Las muestras pueden ser de biopsia con aguja gruesa, biopsia en sacabocados, biopsia por excisión o muestra quirúrgica. NO se aceptan los aspirados con aguja fina ni otras muestras de citología. El laboratorio central debe proporcionar a TRI la confirmación de la recepción de tejido tumoral evaluable antes de la asignación del tratamiento (parte 1) o la aleatorización (parte 2), tal como se describe en el Manual de laboratorio.
    El laboratorio central debe realizar la evaluación de la expresión de PD-L1 en las células tumorales mediante inmunohistoquímica con una muestra de tejido previa al tratamiento, y los resultados deben notificarse a TRI antes de la aleatorización (parte 2).
    E.4Principal exclusion criteria
    Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutations which are sensitive to available targeted inhibitor therapy. Participants with nonsquamous histology and unknown EGFR, ALK, or ROS-1 status are also excluded.
    Participants with known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF) V600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible.
    Participants with untreated central nervous system metastases.
    Participants with leptomeningeal metastases (carcinomatous meningitis).
    Concurrent malignancy requiring treatment.
    Participants with an active, known, or suspected autoimmune disease.
    Prior treatment with anti-TIGIT, anti-PD-(L)1, anti- CTLA-4 antibody or any other antibody
    or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
    Women who are pregnant or breastfeeding
    Participantes con mutaciones del receptor del factor de crecimiento epidérmico (EGFR), de la cinasa del linfoma anaplásico (ALK) o del oncogén c-ros 1 (ROS-1), que son sensibles al tratamiento inhibidor dirigido disponible. Todos los participantes con histología no epidermoide deben haber sido analizados para el estado de mutación de EGFR, ROS-1 y ALK. Se excluyen los participantes con histología no epidermoide y estado de EGFR, ALK o ROS-1 desconocido.
    Participantes con mutaciones de V600E del protooncogén de fibrosarcoma rápidamente acelerado B (BRAF) conocidas que son sensibles al tratamiento inhibidor dirigido disponible. Son aptos los participantes con estado de mutación del gen BRAF desconocida o indeterminada.
    Participantes con metástasis en el sistema nervioso central no tratadas.
    Participantes con metástasis leptomeníngeas (meningitis carcinomatosa).
    Neoplasia maligna concomitante que requiere tratamiento.
    Participantes con una enfermedad autoinmunitaria activa, conocida o presunta.
    Tratamiento previo con un anticuerpo anti-TIGIT, anti-PD-(L)1, anti-CTLA-4 o con cualquier otro anticuerpo o fármaco que actúe de manera específica sobre la coestimulación de linfocitos T o las vías de los puntos de control.
    Mujeres embarazadas o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of AEs meeting protocol-defined DLT criteria, AEs, TRAEs, SAEs, AEs leading to discontinuation, and deaths
    - PFS based on RECIST v1.1 by BICR
    -Incidencia de acontecimientos adversos (AA) que cumplan los criterios de TLD definidos en el protocolo, AA, acontecimientos adversos relacionados con el tratamiento (AART), acontecimientos adversos graves (AAG), AA que provoquen la interrupción del tratamiento y muertes.

    -(RECIST) v1.1 con base en la revisión central independiente enmascarada (RCIE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Incidence of AEs meeting protocol-defined DLT criteria, AEs, TRAEs, SAEs, AEs leading to discontinuation, and deaths: ~ 4years
    -PFS based on RECIST v1.1 by BICR ~ 25 months
    -Incidencia de acontecimientos adversos (AA) que cumplan los criterios de TLD definidos en el protocolo, AA, acontecimientos adversos relacionados con el tratamiento (AART), acontecimientos adversos graves (AAG), AA que provoquen la interrupción del tratamiento y muertes: ~ 4años.

    -(RECIST) v1.1 con base en la revisión central independiente enmascarada (RCIE) ~ 25 meses
    E.5.2Secondary end point(s)
    -PFS based on RECIST v1.1 by BICR and Investigator’s assessment
    -Incidence of AEs, SAEs, AEs leading to discontinuation, and deaths
    -ORR and DOR based on RECIST v1.1 by BICR and Investigator’s assessment
    -OS
    -SSP según RECIST v1.1 con base en la RCIE y y la evaluación del investigador.
    -Incidencia de AA, AAG, AA que provoquen la interrupción y muertes
    -TRO y DdR según RECIST v1.1 con base en la RCIE y la evaluación del investigador.
    -SG
    E.5.2.1Timepoint(s) of evaluation of this end point
    -PFS based on RECIST v1.1 by BICR and Investigator’s assessment: ~ 25months
    -Incidence of AEs, SAEs, AEs leading to discontinuation, and deaths: ~ 4years
    -ORR and DOR based on RECIST v1.1 by BICR and Investigator’s assessment: ~25months
    -OS: ~30months
    -SSP según RECIST v1.1 con base en la RCIE y y la evaluación del investigador: ~ 25meses
    -Incidencia de AA, AAG, AA que provoquen la interrupción y muertes: ~ 4años
    -TRO y DdR según RECIST v1.1 con base en la RCIE y la evaluación del investigador:~25meses
    -SG :~30meses
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Chile
    United States
    Belgium
    France
    Germany
    Italy
    Poland
    Spain
    Argentina
    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
    LVLS
    UVLP
    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 days12
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days12
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 240
    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, participants who continue to demonstrate clinical benefit will be eligible to receive BMS supplied study treatment for the maximum treatment duration specified in protocol. Study treatment 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.
    Al final del estudio, los participantes que sigan demostrando beneficios clínicos estarán en condiciones de recibir el tratamiento del estudio suministrado por BMS durante la duración máxima del tratamiento especificada en el protocolo. El tratamiento del estudio se proporcionará a través de una extensión del estudio, un estudio de continuidad que requiere la aprobación de la autoridad sanitaria responsable y el comité de ética o a través de otro mecanismo a discreción 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 Decision2022-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-14
    P. End of Trial
    P.End of Trial StatusOngoing
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    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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