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    Summary
    EudraCT Number:2018-003200-39
    Sponsor's Protocol Code Number:CA045-011
    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:2021-11-10
    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 number2018-003200-39
    A.3Full title of the trial
    A Phase 1/2 Study to Compare Bempegaldesleukin Combined with Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI alone in Participants with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (mRCC) (PIVOT IO 011)
    Estudio fase 1/2 para comparar bempegaldesleukin combinado con nivolumab y un inhibidor de la tirosina quinasa (TKI) con nivolumab y un TKI solos en participantes con carcinoma de células renales avanzado o metastásico (CCRm) no tratado previamente (PIVOT IO 011).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined with Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI alone in Participants with Previously Untreated Kidney Cancer That is Advanced or has Spread
    Estudio para comparar bempegaldesleukin (BEMPEG: NKTR-214) combinado con nivolumab y un inhibidor de la tirosina quinasa (TKI) con nivolumab y un TKI solos en participantes con cáncer de riñón no tratado previamente que ha avanzado o se ha extendido
    A.4.1Sponsor's protocol code numberCA045-011
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04540705
    A.5.4Other Identifiers
    Name:18-214-15Number:Nektar Therapeutics
    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.5.4Telephone 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 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 and solvent 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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive nameMDX1106, 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: 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.3.2Product code NKTR-214 - 1 mg vial
    D.3.4Pharmaceutical form Powder 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 INNNot yet assigned
    D.3.9.1CAS number 1939126-74-5
    D.3.9.2Current sponsor codeNKTR-214
    D.3.9.3Other descriptive nameBMS986321
    D.3.9.4EV Substance CodeSUB192964
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    D.2.1.1.1Trade name CABOMETYX
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma
    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 nameCabozantinib
    D.3.2Product code XL184
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCabozantinib
    D.3.9.1CAS number 1140909-48-3
    D.3.9.2Current sponsor codeXL184
    D.3.9.3Other descriptive nameCabozantinib S-malate
    D.3.9.4EV Substance CodeSUB176318
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    Renal Cell Carcinoma
    Carcinoma de células renales
    E.1.1.1Medical condition in easily understood language
    Kidney cancer
    Cáncer de riñón
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11.0
    E.1.2Level HLT
    E.1.2Classification code 10038408
    E.1.2Term Renal cell carcinomas
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067946
    E.1.2Term Renal cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10050513
    E.1.2Term Metastatic renal cell carcinoma
    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
    New countries are only participating in part 2 of the study the part 2 objectives are:
    -To compare ORR of nivolumab, bempegaldesleukin,
    and cabozantinib to that of nivolumab and
    cabozantinib in all randomized participants with
    previously untreated advanced or metastatic RCC

    - ORR by RECIST 1.1 by Investigator
    Los nuevos países solo participan en la parte 2 del estudio.
    Los objetivos de la parte 2 son:
    - Comparar la TRO de nivolumab, bempegaldesleukin y cabozantinib con la de nivolumab y cabozantinib en todos los participantes aleatorizados con CCR no tratado previamente avanzado o metastásico
    - TRO según los RECIST 1.1 por el investigador
    E.2.2Secondary objectives of the trial
    -To compare PFS of nivolumab, bempegaldesleukin,
    and cabozantinib to that of nivolumab and
    cabozantinib in all randomized participants with
    previously untreated advanced or metastatic RCC
    - PFS by RECIST 1.1 by Investigator
    - To evaluate OS of nivolumab, bempegaldesleukin,
    and cabozantinib and that of nivolumab and
    cabozantinib in all randomized participants with
    previously untreated advanced or metastatic RCC
    - OS
    - To assess safety and tolerability of nivolumab,
    bempegaldesleukin, and cabozantinib and that of
    nivolumab and cabozantinib in all randomized
    participants with previously untreated advanced or
    metastatic RCC
    - Worst grade AEs, SAEs, AEs leading to
    discontinuation, immune-mediated AEs, and
    worst grade clinical laboratory values
    - Comparar la SLP de nivolumab, bempegaldesleukin y cabozantinib con la de nivolumab y cabozantinib en todos los participantes aleatorizados con CCR avanzado o metastásico no tratado previamente
    - SLP según los RECIST 1.1 por el investigador
    - Evaluar la SG de nivolumab, bempegaldesleukin y cabozantinib y la obtenida con nivolumab y cabozantinib en todos los participantes aleatorizados con CCR avanzado o metastásico no tratado previamente
    - SG
    - Evaluar la seguridad y la tolerabilidad de nivolumab, bempegaldesleukin y cabozantinib y la de nivolumab y cabozantinib en todos los participantes aleatorizados con CCR avanzado o metastásico no tratado previamente
    - AA de peor grado, AAG, AA que conducen a la suspensión, AA mediados por el sistema inmunitario y valores de laboratorio clínico de peor grado
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may also have sarcomatoid features
    - Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer (AJCC) Stage 4) RCC
    - No prior systemic therapy, including prior PD-L1 therapy, for RCC is allowed with the following exception:
    i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed. Therapy must have included an agent that targets vascular endothelial
    growth factor (VEGF) pathway or VEGF receptors and recurrence must have occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
    - Life Expectancy ≥ 12 weeks
    - Karnofsky Performance Status (KPS) of at least 70%
    - Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
    per RECIST 1.1 criteria
    - Males and females must agree to follow specific methods of contraception, if applicable
    - Confirmación histológica de carcinoma de células renales (CCR) con componente de células claras, incluidos participantes que pueden tener también rasgos sarcomatoides
    - CCR avanzado (no susceptible de cirugía o radioterapia curativas) o metastásico (estadio IV del AJCC (American Joint Committee on Cancer))
    - No se permite ningún tratamiento sistémico previo, incluida terapia previa con PD-L1, para el CCR, con la siguiente excepción:
    i) Se permite un tratamiento adyuvante o neoadyuvante previo para el CCR completamente resecable. El tratamiento debe haber incluido un agente que se dirige a la vía del factor de crecimiento endotelial vascular (VEGF) o a los receptores del VEGF y la recidiva debe haberse producido al menos 6 meses después de la última dosis de tratamiento adyuvante o neoadyuvante
    - Esperanza de vida ≥ 12 semanas
    - Estado funcional de Karnofsky (KPS) de al menos 70%
    - Enfermedad medible mediante tomografía computarizada (TC) o resonancia magnética (RM) según los criterios RECIST 1.1.
    - Los hombres y las mujeres deben estar de acuerdo en utilizar métodos anticonceptivos específicos, si corresponde
    E.4Principal exclusion criteria
    - Active CNS brain metastases or leptomeningeal metastases
    - Active, known or suspected autoimmune disease
    - Inadequately treated adrenal insufficiency
    - History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA/TIA arterial thromboembolic event (eg, internal jugular vein thrombosis) within 3 months prior to treatment assignment (Part 1) and randomization (Part 2)
    NOTE: Other protocol defined inclusion/exclusion criteria apply
    - Metástasis cerebrales activas o metástasis leptomeníngeas
    - Enfermedad autoinmune activa, conocida o de sospecha
    - Insuficiencia suprarrenal tratada inadecuadamente
    - Antecedentes de embolia pulmonar (EP), trombosis venosa profunda (TVP) o evento tromboembólico venoso o arterial no ACV/AIT clínicamente significativo (p. ej., trombosis de la vena yugular interna) dentro de los 3 meses anteriores a la asignación del tratamiento (Parte 1) y la aleatorización (Parte 2)
    NOTA: Se aplican otros criterios de inclusión / exclusión definidos por el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator (Part 2) [ Time Frame: Up to 20 months from
    start of Part 2
    Tasa de respuestas objetivas (TRO) según los criterios de evaluación de la respuesta en tumores sólidos (RECIST) 1.1 por el investigador (Parte 2) [Marco de tiempo: hasta 20 meses desde el inicio de la Parte 2]
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator (Part 2) [ Time Frame: Up to 20 months from
    start of Part 2
    Tasa de respuestas objetivas (TRO) según los criterios de evaluación de la respuesta en tumores sólidos (RECIST) 1.1 por el investigador (Parte 2) [Marco de tiempo: hasta 20 meses desde el inicio de la Parte 2]
    E.5.2Secondary end point(s)
    -Progression-free survival (PFS) by RECIST 1.1 by Investigator (Part 2) [ Time Frame: Up to 32 months from start of Part 2 ]
    -Overall survival (OS) (Part 2) [ Time Frame: Up to 60 months ]
    -Incidence of AEs by severity (Part 2) [ Time Frame: Up to 5 years ]
    -Incidence of SAEs (Part 2) [ Time Frame: Up to 5 years ]
    -Incidence of AEs leading to discontinuation (Part 2) [ Time Frame: Up to 5 years ]
    -Incidence of imAEs (Part 2) [ Time Frame: Up to 5 years ]
    -Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 2) [ Time Frame: Up to 5 years ]
    -Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 2) [ Time Frame: Up to 5 years ]
    -Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 2) [ Time Frame: Up to 5 years ]
    - Supervivencia Libre de Progresión (SLP) según RECIST 1.1 por el investigador (Parte 2) [Marco de tiempo: hasta 32 meses desde el inicio de la Parte 2]
    - Supervivencia Global (SG) (Parte 2) [Marco de tiempo: hasta 60 meses]
    - Incidencia de AAs por gravedad (Parte 2) [Marco de tiempo: hasta 5 años]
    - Incidencia de AAGs (Parte 2) [Marco de tiempo: hasta 5 años]
    - Incidencia de AAs que conducen a la suspensión (Parte 2) [Marco de tiempo: hasta 5 años]
    - Incidencia de AA A mediados por el sistema inmunitario (Parte 2) [Marco de tiempo: hasta 5 años]
    - Incidencia de los cambios en los resultados de laboratorio clínico por gravedad:
    Pruebas hematológicas (Parte 2) [Marco de tiempo: hasta 5 años]
    - Incidencia de los cambios en los resultados de laboratorio clínico por gravedad:
    Pruebas de química clínica (Parte 2) [Marco de tiempo: hasta 5 años]
    - Incidencia de los cambios en los resultados de laboratorio clínico por gravedad:
    Pruebas de análisis de orina (Parte 2) [Marco de tiempo: hasta 5 años]
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Progression-free survival (PFS) by RECIST 1.1 by Investigator (Part 2) [ Time Frame: Up to 32 months from start of Part 2 ]
    -Overall survival (OS) (Part 2) [ Time Frame: Up to 60 months ]
    -All other endpoints [ Time Frame: Up to 5 years ]
    - Supervivencia Libre de Progresión (SLP) según RECIST 1.1 por el investigador (Parte 2) [Marco de tiempo: hasta 32 meses desde el inicio de la Parte 2]
    - Supervivencia Global (SG) (Parte 2) [Marco de tiempo: hasta 60 meses]
    - Todos los demás criterios de valoración [Marco de tiempo: hasta 5 años]
    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 No
    E.6.5Efficacy No
    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 No
    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
    Dose escalation
    Escalada de dosis
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Brazil
    Canada
    Mexico
    Russian Federation
    United States
    France
    Germany
    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
    The end of trial is defined as the last participant’s last study visit, or last survival assessment, or for a maximum of 5 years of survival follow-up, whichever occurs first. Study completion is defined as the final date on which data for the primary endpoint for Part 2 was or is expected to be collected, if this is not the same.
    El final del ensayo se define como la última visita del estudio del último participante, o la última evaluación de supervivencia, o durante un máximo de 5 años de seguimiento de supervivencia, lo que ocurra primero. La finalización del estudio se define como la fecha final en la que se recopilaron o se espera que se recopilen los datos para el criterio principal de valoración de la Parte 2, si no es la misma.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 209
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 89
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 109
    F.4.2.2In the whole clinical trial 298
    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 in Section 5.1.2. 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 finalizar el estudio, los participantes que continúen demostrando beneficio clínico serán elegibles para recibir el tratamiento de estudio proporcionado por BMS durante la duración máxima del tratamiento en la sección 5.1.2. El tratamiento de estudio será proporcionado a través de una extensión del estudio, un estudio "rollover" autorizado por la autoridad sanitaria y comité ético correspondientes, u 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 Decision2022-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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