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    Summary
    EudraCT Number:2021-003208-42
    Sponsor's Protocol Code Number:CA209-6GE
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2022-03-11
    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 number2021-003208-42
    A.3Full title of the trial
    A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Administered Subcutaneously (Nivo SC) Versus Intravenous Administration of Nivolumab in Participants with Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection
    Estudio farmacocinético en fase III, abierto, aleatorizado y de no inferioridad de nivolumab administrado por vía subcutánea (Nivo s.c.) en comparación con la administración intravenosa de nivolumab en participantes con melanoma en estadio IIIA/B/C/D o estadio IV tras la resección completa en un entorno adyuvante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Pharmacokinetic Study of Nivolumab Administered Subcutaneously vs Intravenous Nivolumab in Participants with Stage III A/B/C/D or Stage IV Melanoma Following Complete Resection
    Estudio farmacocinético de nivolumab administrado por vía subcutánea en comparación con nivolumab intravenoso en participantes con melanoma en estadio IIIA/B/C/D o estadio IV tras la resección completa
    A.3.2Name or abbreviated title of the trial where available
    CheckMate-6GE: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 6GE
    CheckMate-6GE: Evaluación del ensayo clínico de la vía CHECKpoint y nivoluMAb 6GE
    A.4.1Sponsor's protocol code numberCA209-6GE
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1266-6116
    A.5.4Other Identifiers
    Name:INDNumber:150,904
    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 number+34914565300
    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 Subcutaneous coformulated with excipient rHuPH20
    D.3.2Product code BMS-986298-01
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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-986298
    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 number150
    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 Yes
    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 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 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-10 ml 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
    D.3.9.4EV Substance CodeSUB32944
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Resected Stage IIIA/B/C/D or Stage IV melanoma in an adjuvant setting
    Melanoma en estadio IIIA/B/C/D o estadio IV tras la resección completa en un entorno adyuvante
    E.1.1.1Medical condition in easily understood language
    Melanoma Stage III or Stage IV
    Melanoma en estadio III o estadio IV
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025671
    E.1.2Term Malignant melanoma stage IV
    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 10025670
    E.1.2Term Malignant melanoma stage III
    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
    Part 1:
    - To demonstrate PK (pharmacokinetics) non-inferiority of nivolumab SC coformulated with rHuPH20 (recombinant human hyaluronidase PH20 enzyme) versus nivolumab IV (intravenous administration).

    Part 2:
    - To characterize the PK of nivolumab SC coformulated with rHuPH20.
    Parte 1: Demostrar la no inferioridad FC de nivolumab coformulado con rHuPH20 frente a nivolumab i.v.

    Parte 2: Caracterizar la FC de nivolumab s.c. coformulado con rHuPH20.
    E.2.2Secondary objectives of the trial
    Part 1, Key secondary:
    - To assess the safety and tolerability of nivolumab SC coformulated with rHuPH20 and nivolumab IV.
    - To assess the efficacy of nivolumab SC coformulated with rHuPH20 and nivolumab IV.

    Part 1, Other Secondary:
    - To characterize additional PK parameters following nivolumab SC coformulated with rHuPH20 and nivolumab IV.
    - To evaluate the immunogenicity of nivolumab SC coformulated with rHuPH20 and nivolumab IV and the impact of anti-nivolumab antibodies on safety.
    - To assess satisfaction with route of treatment administration.

    Part 2:
    - To characterize additional PK parameters following nivolumab SC coformulated with rHuPH20.
    - To assess the safety and tolerability profile of nivolumab SC injection with rHuPH20.
    - To assess the immunogenicity of nivolumab and the impact of anti-nivolumab antibodies on safety.
    Parte 1, Secundarios clave:
    -Evaluar la seguridad y tolerabilidad de nivolumab s.c. coformulado con rHuPH20 y nivolumab i.v.
    -Evaluar la eficacia de nivolumab s.c. coformulado con rHuPH20 y nivolumab i.v.
    Parte 1, Otros secundarios:
    -Caracterizar parámetros FC adicionales tras la administración de nivolumab s.c. coformulado con rHuPH20 y nivolumab i.v.
    -Evaluar la inmunogenicidad de nivolumab s.c. coformulado con rHuPH20 y nivolumab i.v. y el impacto de los anticuerpos antinivolumab en la seguridad.
    -Evaluar la satisfacción con la vía de administración del tratamiento.
    Parte 2:
    -Caracterizar parámetros FC adicionales tras la administración de nivolumab s.c. coformulado con rHuPH20.
    -Evaluar el perfil de seguridad y tolerabilidad de la inyección s.c. de nivolumab con rHuPH20.
    -Evaluar la inmunogenicidad de nivolumab s.c. y el impacto de los anticuerpos antinivolumab en la seguridad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • All participants must have been diagnosed with either Stage IIIA (> 1mm tumor in lymph node)/B/C/D or Stage IV melanoma by AJCC 8th edition and have histologically confirmed melanoma (as documented in the pathology report) that is completely surgically resected (free of disease) with negative margins in order to be eligible. All melanomas, except uveal and mucosal melanoma, regardless of primary site of disease, will be allowed.
    • Complete resection must be performed within 12 weeks prior to randomization (Part 1) or treatment assignment (Part 2). Management of residual lymph nodes after positive sentinel lymph node biopsy (ie, completion lymph node dissection) will be as per local standards and recommendations for the individual participant.
    • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
    -Todos los participantes deben contar con diagnóstico de melanoma en estadio IIIA (>1 mm de tumor en el ganglio linfático)/B/C/D o en estadio IV según lo determinado por el AJCC 8.ª edición y presentar melanoma confirmado histológicamente (según lo documentado en el informe de anatomopatología) que se haya resecado quirúrgicamente por completo (sin enfermedad) con bordes negativos. Se permitirán todos los melanomas, excepto el melanoma uveal y mucoso, independientemente del foco principal de la enfermedad.
    -La resección completa debe realizarse en las 12 semanas anteriores a la aleatorización (parte 1) o asignación de tratamiento (parte 2). El tratamiento de los ganglios linfáticos residuales tras la biopsia de ganglios linfáticos centinela con resultado positiva (es decir, linfadenectomía completa) se realizará según las normas locales y las recomendaciones para cada participante.
    -Los participantes deben tener un estado general según el Grupo Oncológico Cooperativo de la Costa Este de los EE. UU. (ECOG) ≤1.
    E.4Principal exclusion criteria
    • History of uveal or mucosal melanoma.
    • Untreated/unresected CNS metastases or leptomeningeal metastases.
    • Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
    • Participants with serious or uncontrolled medical disorders within 4 weeks prior to screening.
    - Additionally, in the case of prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, acute symptoms must have resolved and based on investigator assessment in consultation with the Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment.
    • Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization (Part 1) or treatment assignment (Part 2) (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization/treatment assignment and the patient has no evidence of disease). Participants with history of prior early stage basal/squamous cell skin cancer or noninvasive or in situ cancers that have undergone definitive treatment at any time are also eligible.
    • Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
    • Any condition that according to investigator criteria makes a participant ineligible from participation in the study, including but not limited to medical conditions (including psychological, psychiatric), or social conditions; or conditions that can impact ability to comply with protocol requirements (eg, conditions that preclude the use of IV or subcutaneous [SC] route of study drug administration) or that can put the participant at risk. Participants with history of self-harm including suicidal attempts will be excluded from the study.
    • Prior immunotherapy treatments for any prior malignancies are not permitted (such as, but not limited to anti-programmed death-1, anti-programmed death-ligand 1, anti-programmed death-ligand 2, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways).
    • Participants treated with anti-cancer therapy directed against the resected melanoma (for example, but not limited to, systemic, local, radiation, and radiopharmaceuticals) except:
    - Surgery for the melanoma lesion(s)
    - Adjuvant radiation therapy after neurosurgical resection for CNS lesions
    - Prior adjuvant interferon completed ≥ 6 months prior to randomization (Part 1) or treatment assignment (Part 2).
    • Treatment with any live attenuated vaccine within 30 days of first study treatment (Vaccines that are not live attenuated are allowed, including COVID-19 vaccines).
    • History of allergy or hypersensitivity to study drug components or device components.
    • Known human immunodeficiency virus (HIV) positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count < 350 cells/uL.
    Participants with HIV are eligible if:
    i) they have received antiretroviral therapy (ART) for at least 4 weeks prior to randomization (Part 1) or treatment assignment (Part 2) as clinically indicated while enrolled on study.
    ii) they continue on ART as clinically indicated while enrolled on study.
    iii) CD4 counts and viral load are monitored per standard of care by a local healthcare provider.
    NOTE: Testing for HIV must be performed at sites where mandated locally. HIV positive participants must be excluded where mandated locally.

    Other protocol-defined exclusion criteria apply
    -Antecedentes de melanoma uveal o mucoso.
    -Metástasis del SNC sin tratar/resecar o metástasis leptomeníngeas.
    -Participantes con una enfermedad autoinmunitaria activa, conocida o presunta. Se permite la inclusión de participantes con diabetes mellitus tipo 1, hipotiroidismo que solo requiera reemplazo hormonal, trastornos cutáneos (como vitíligo, psoriasis o alopecia) que no requieran tratamiento sistémico, o afecciones que no se prevé que vuelvan a aparecer en ausencia de un desencadenante externo.
    -Participantes con trastornos médicos graves o sin controlar en las 4 semanas previas a la selección.
    -En caso de infección previa por coronavirus del síndrome respiratorio agudo grave de tipo 2 (SARS-CoV-2), los síntomas agudos deben haberse resuelto, y según la evaluación del investigador en consulta con el supervisor médico, no hay secuelas que pondrían al participante ante un mayor riesgo de recibir el tratamiento en investigación.
    -Neoplasia maligna concomitante (presente durante la selección) que requiera tratamiento o antecedentes de neoplasia maligna activa previa en los 2 años anteriores a la aleatorización (parte 1) o asignación del tratamiento (parte 2) (es decir, los participantes con antecedentes de neoplasia maligna previa son elegibles si el tratamiento se completó al menos 2 años antes de la aleatorización/asignación del tratamiento y el paciente no presenta indicios de enfermedad). También son elegibles los participantes con antecedentes de cáncer de piel basocelular/epidermoide en fase temprana previo o cáncer no invasivo o localizado que se hayan sometido a tratamiento definitivo en cualquier momento.
    -Participantes con una afección que requiera tratamiento sistémico con corticoesteroides (>10 mg una vez al día de un equivalente a prednisona) en los 14 días anteriores o bien con otros inmunodepresores en los 30 días anteriores al inicio del tratamiento del estudio. Se permiten los corticoesteroides inhalados o tópicos y las dosis de corticoesteroides para reemplazo suprarrenal >10 mg al día de un equivalente a prednisona en ausencia de una enfermedad autoinmunitaria activa.
    -Cualquier afección que, de acuerdo con los criterios del investigador, haga que un participante no sea elegible para participar en el estudio, incluidas, entre otras, enfermedades (psicológicas, psiquiátricas) o afecciones de tipo social; o afecciones que puedan afectar a la capacidad de cumplir con los requisitos del protocolo (p. ej., afecciones que impidan el uso de la vía i.v. o subcutánea [s.c.] de administración del fármaco del estudio) o que puedan poner al participante en riesgo. Los participantes con antecedentes de autolesión, incluidos los intentos de suicidio, serán excluidos del estudio.
    -Los tratamientos de inmunoterapia previos para tratar neoplasias malignas anteriores no están permitidos (entre otros, anticuerpos antimuerte celular programada 1, antiligando de muerte celular programada 1, antiligando de muerte celular programada 2 o cualquier otro anticuerpo o fármaco dirigido específicamente a la coestimulación de los linfocitos T o a las vías de puntos de control inmunitario).
    -Participantes que hayan recibido un tratamiento antineoplásico dirigido contra el melanoma resecado (por ejemplo, entre otros, sistémicos, locales, radioterapéuticos y radiofarmacéuticos), excepto: Cirugía para la(s) lesión(es) originadas por el melanoma; Radioterapia adyuvante después de la resección neuroquirúrgica de las lesiones del SNC; Interferón adyuvante previo completado ≥6 meses antes de la aleatorización (parte 1) o de la asignación del tratamiento (parte 2); Tratamiento con cualquier vacuna atenuada elaborada con microbios vivos en los 30 días previos al primer tratamiento del estudio (están permitidas las vacunas que no sean atenuadas elaboradas con microbios vivos, incluidas las vacunas contra la COVID-19)
    -Antecedentes de alergia o hipersensibilidad a los componentes del fármaco del estudio o del dispositivo.
    -Virus de la inmunodeficiencia humana (VIH) positivo conocido con una infección oportunista definida por el SIDA en el último año, o un recuento actual de CD4 < 350 células/uL. Los participantes con VIH son elegibles si
    i) han recibido terapia antirretroviral (TAR) durante al menos 4 semanas antes de la aleatorización (Parte 1) o de la asignación del tratamiento (Parte 2) según esté clínicamente indicado mientras estén inscritos en el estudio.
    ii) Que continúen con la terapia antirretroviral según esté clínicamente indicado mientras estén inscritos en el studio.iii) los recuentos de CD4 y la carga viral se controlan según el estándar de atención por parte de un proveedor sanitario local. NOTA: La prueba del VIH debe realizarse en los centros donde se exija localmente. Los participantes seropositivos deben ser excluidos cuando sea obligatorio a nivel local.
    Se aplican otros criterios de exclusión definidos en el protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1
    -Cavgd28 (Time averaged nivolumab serum concentration over the first 28 days)
    - Cminss (Minimum nivolumab serum concentration at steady-state)

    Part 2
    -Cavgd28
    Parte 1
    -Cavgd28 (Concentración sérica de nivolumab promediada en el tiempo durante los primeros 28 días)
    - Cminss (Concentración sérica mínima de nivolumab en situación de equilibrio)
    Parte 2
    -Cavgd28
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1
    -Cavgd28 : First 28 days of treatment
    -Cminss : 17 weeks after the start of treatment

    Part 2
    -Cavgd28 : First 28 days of treatment
    Parte 1
    -Cavgd28: Primeros 28 días de tratamiento
    -Cminss : 17 semanas después del comienzo del tratamiento
    Parte 2
    -Cavgd28: Primeros 28 días de tratamiento
    E.5.2Secondary end point(s)
    Part 1, Key secondary:
    a) Incidence of all AEs/SAEs, treatment-related AEs, including IMAEs, SAEs, AEs (including device-related adverse reactions, injection/infusion-related AEs) leading to discontinuation or death, and laboratory abnormalities for each treatment group.
    b) RFS (recurrence-free survival) per investigator - rates at 12, 18, 24, and 36 months follow-up.
    c) OS (overall survival) rates at 12, 18, 24, and 36 months follow-up.

    Part 1, other secondary:
    d) Cmind28 (minimum nivolumab serum concentration on Day 28), Cmax1 (maximum nivolumab serum concentration after the first dose), Tmax (time to maximum nivolumab serum concentration after the first dose.)
    e) Cmaxss (maximum nivolumab serum concentration at steady-state), and Cavgss (time-averaged nivolumab serum concentration at steady-state).
    f) Percentage of participants who develop anti-nivolumab antibodies and neutralizing antibodies, if applicable, and the impact of anti-nivolumab antibodies on AEs, administration-related reactions, and events within MedDRA SMQ Anaphylactic reactions
    g) Mean CTSQ (Cancer Treatment Satisfaction Questionnaire) Satisfaction domain scores and score change from baseline at each assessment time point.

    Part 2
    h) Cmind28, Cmax1, Tmax
    i) Cmaxss, Cavgss, and Cminss.
    j) Incidence of AEs/SAEs, treatment-related AEs, including IMAEs, SAEs, AEs (including device-related adverse reactions, injection/infusion-related AEs) leading to discontinuation or death, and laboratory abnormalities.
    k) Percentage of participants who develop anti-nivolumab antibodies and neutralizing antibodies, if applicable, and the impact of anti-nivolumab antibodies on AEs, administration-related reactions, and events within MedDRA SMQ Anaphylactic reactions.
    Parte1, Secundarios clave:
    a) Incidencia de todos los AA/AAG, AA relacionados con el tratamiento, incluidos los AAI, AAG, AA (incluidas las reacciones adversas relacionadas con el dispositivo, AA relacionados con la inyección/infusión) que provoquen la interrupción del tratamiento o la muerte y anomalías en el análisis para cada grupo de tratamiento.
    b) Tasas de SSR (según el investigador) a los 12, 18, 24 y 36 meses de seguimiento.
    c) Tasas de SG a los 12, 18, 24 y 36 meses de seguimiento.
    Parte 1, Otros secundarios:
    d) Cmind28 (concentración sérica mínima de nivolumab en el día 28), Cmax1 (concentración sérica máxima de nivolumab después de la primera dosis), Tmax (tiempo hasta la concentración sérica máxima de nivolumab después de la primera dosis).
    e) Cmaxss (concentración sérica máxima de nivolumab en situación de equilibrio), y Cavgss (concentración sérica de nivolumab promediada en el tiempo en situación de equilibrio).
    e) Porcentaje de participantes que desarrollan anticuerpos antinivolumab y anticuerpos neutralizantes, si procede, y el impacto de los anticuerpos antinivolumab sobre los AA, las reacciones relacionadas con la administración y los acontecimientos en las reacciones anafilácticas de las SMQ del MedDRA.
    g) Puntuaciones medias del dominio de satisfacción del CTSQ y variación con respecto al valor inicial de la puntuación en cada punto temporal de evaluación.
    Parte 2:
    h) Cmind28, Cmaxl, Tmáx
    i) Cmaxss, Cavgss y Cminss
    j) Incidencia de AA/AAG, AA relacionados con el tratamiento, incluidos los AAI, AAG, AA (incluidas las reacciones adversas relacionadas con el dispositivo, AA relacionados con la inyección/infusión) que provoquen la interrupción del tratamiento o la muerte y anomalías en el análisis.
    k) Porcentaje de participantes que desarrollan anticuerpos antinivolumab y anticuerpos neutralizantes, si procede, y el impacto de los anticuerpos antinivolumab sobre los AA, las reacciones relacionadas con la administración y los acontecimientos en las reacciones anafilácticas de las SMQ del MedDRA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) Up to 100 days after the last treatment of study intervention or up to discontinuation of study treatment
    b) Until recurrence event, up to minimum follow-up of 12 months from last participant randomized in the study or death whichever is earlier
    c) Until death, up to 36 months
    d) First 28 days of treatment
    e) 17 weeks after the start of treatment
    f) Up to 100 days after the last study treatment or up to discontinuation of study treatment
    g) At each assessment time Point
    h) First 28 days of treatment
    i) 17 weeks after the start of treatment
    j) Up to 100 days after the last treatment of study intervention or up to discontinuation of study treatment
    k) Up to 100 days after the last study treatment or up to discontinuation of study treatment
    a)Hasta 100 dias después del último trat.de la intervención del estudio o hasta la interrupción del trat.del estudio b)Hasta el evento de recurrencia, hasta un seguimiento mínimo de 12 meses desde el último participante aleatorizado en el estudio o la muerte, lo que ocurra primero c)Hasta la muerte, hasta 36 meses d)Los primeros 28 días de trat.e)17 semanas después del inicio del trat.f)Hasta 100 días después del último trat.del estudio o hasta la interrupción del mismo g)En cada momento de la evaluación h)Los primeros 28 días de trat. i)17 semanas después del inicio del trat. j)Hasta 100 días después del último trat.de la intervención del estudio o hasta la interrupción del trat.del estudio k)Hasta 100 días después del último trat.del estudio o hasta la interrupción del trat.del estudio
    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 No
    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
    Tolerability, Immunogenicity
    Tolerabilidad, inmunogenicidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Canada
    United States
    Belgium
    France
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    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
    End of trial is defined as the last participant last visit or completion of Follow-up Visit 2.
    El final del ensayo se define como la última visita del último participante o la finalización de la visita de seguimiento 2.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 276
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 103
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In situations where consent cannot be given by participants, consent can be given by their legally acceptable representatives (as per country regulation) in accordance with ICH GCP Guidelines.
    En situaciones en las que los participantes no puedan dar su consentimiento, éste puede ser dado por sus representantes legales (según la normativa del país) de acuerdo con las Directrices de BPC de la ICH.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 235
    F.4.2.2In the whole clinical trial 379
    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 end of the study, BMS will not continue to provide BMS-supplied study intervention to participants/investigators unless BMS chooses to extend the study. The investigator should ensure that the participant receives appropriate standard of care to treat the condition under study.
    Al final del estudio, BMS no seguirá proporcionando los suministros de BMS del estudio a los participantes/investigadores, a menos que BMS decida ampliar el estudio. El investigador debe asegurarse de que el participante reciba la atención estándar adecuada para tratar la enfermedad en estudio.
    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 Decision2022-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-03
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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