Un estudio de nivolumab subcutáneo versus nivolumab intravenoso en participantes con carcinoma de células renales de células claras tratado previamente que está avanzado o se ha propagado (CheckMate-67T)
Ensayo de fase 3, abierto, aleatorizado, de no inferioridad de la formulación subcutánea de nivolumab frente a nivolumab intravenoso en participantes con carcinoma de células renales de células claras avanzado o metastásico que han recibido tratamiento sistémico previo
The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- Fase 3
Acceso ampliado
Acceso ampliado
Ya no está disponible
- Disponible: el acceso ampliado está actualmente disponible para este tratamiento en investigación, y los pacientes que no participan en el estudio clínico pueden obtener acceso al medicamento, producto biológico o dispositivo médico. en estudio.
- Ya no está disponible: el acceso ampliado estaba disponible para esta intervención anteriormente, pero no está disponible actualmente y no lo estará en el futuro.
- No disponible temporalmente: el acceso ampliado no está disponible actualmente para esta intervención, pero se espera que esté disponible en el futuro.
- Aprobado para marketing: la intervención ha sido aprobado por la Administración de Drogas y Alimentos de los EE. UU. para uso público.
Contactos y Ubicaciones
Ubicaciones de estudio
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Buenos Aires
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Buenos Aires, Buenos Aires, Argentina, C1426ANZ
- Local Institution - 0038
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Capital Federal, Buenos Aires, Argentina, C1419AHN
- Local Institution - 0095
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Mar del Plata, Buenos Aires, Argentina, 7600
- Local Institution - 0058
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Pergamino, Buenos Aires, Argentina, B2700CPM
- Local Institution - 0037
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Córdoba Province
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Parana, Córdoba Province, Argentina, 5000
- Local Institution - 0079
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Río Cuarto, Córdoba Province, Argentina, 5800
- Local Institution - 0030
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Río Negro Province
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Viedma, Río Negro Province, Argentina, R8500ACE
- Local Institution - 0066
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San Juan Province
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San Juan, San Juan Province, Argentina, J5402DIL
- Local Institution - 0056
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Paraná
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Curitiba, Paraná, Brasil, 80520-174
- Local Institution - 0064
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, Brasil, 98700-000
- Local Institution - 0107
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Porto Alegre, Rio Grande do Sul, Brasil, 91350-200
- Local Institution - 0039
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, Brasil, 20230-130
- Local Institution - 0090
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São Paulo
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Barretos, São Paulo, Brasil, 014784-000
- Local Institution - 0071
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São José do Rio Preto, São Paulo, Brasil, 15090-000
- Local Institution - 0070
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São Paulo, São Paulo, Brasil, 01246-000
- Local Institution - 0081
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São Paulo, São Paulo, Brasil, 01327-0001
- Local Institution - 0096
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Brno, Chequia, 656 53
- Local Institution - 0063
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Hradec Králové, Chequia, 500 05
- Local Institution - 0036
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Olomouc, Chequia, 77900
- Local Institution - 0020
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Ostrava, Chequia, 708 52
- Local Institution - 0099
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Prague, Chequia, 140 59
- Local Institution - 0010
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Praha 8 Liben, Chequia, 18081
- Local Institution - 0106
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Araucania
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Temuco, Araucania, Chile
- Local Institution - 0084
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile
- Local Institution - 0005
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Santiago, Santiago Metropolitan, Chile, 7500653
- Local Institution - 0104
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Santiago, Santiago Metropolitan, Chile, 7500921
- Local Institution - 0076
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2520598
- Local Institution - 0077
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Barcelona, España, 08003
- Local Institution - 0048
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Barcelona, España, 08035
- Local Institution - 0102
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Barcelona, España, 08041
- Local Institution - 0049
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Madrid, España, 28026
- Local Institution - 0072
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Madrid, España, 28033
- Local Institution - 0067
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Madrid, España, 28046
- Local Institution - 0074
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Madrid, España, 28050
- Local Institution - 0075
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Sabadell, España, 08208
- Local Institution - 0032
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Santander, España, 39008
- Local Institution - 0086
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Seville, España, 31013
- Local Institution - 0059
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Local Institution
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New York
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Buffalo, New York, Estados Unidos, 14263
- Local Institution - 0025
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Pennsylvania
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West Reading, Pennsylvania, Estados Unidos, 19611
- Local Institution - 0088
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Tampere, Finlandia, 33521
- Local Institution - 0017
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Nice, Francia, 6189
- Local Institution
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Suresnes, Francia, 92151
- Local Institution - 0051
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Villejuif, Francia, 94800
- Local Institution - 0068
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Dublin
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Tallaght, Dublin, Irlanda
- Local Institution - 0060
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Cremona, Italia, 26100
- Local Institution - 0033
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Florence, Italia, 50134
- Local Institution - 0008
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Meldola, Italia, 47014
- Local Institution - 0027
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Milan, Italia, 20141
- Local Institution - 0018
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Milan, Italia, 20133
- Local Institution
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Padova, Italia, 35128
- Local Institution - 0014
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Parma, Italia, 43126
- Local Institution - 0082
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Pavia, Italia, 27100
- Local Institution - 0092
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Roma, Italia, 00168
- Local Institution - 0100
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Rome, Italia, 00152
- Local Institution - 0091
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Terni, Italia, 05100
- Local Institution - 0057
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Coahuila
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Torreón, Coahuila, México, 27010
- Local Institution - 0101
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Mexico City
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Tlalpan, Mexico City, México, 14080
- Local Institution - 0089
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Nuevo León
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Monterrey, Nuevo León, México, 64460
- Local Institution - 0103
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Monterrey, Nuevo León, México, 64710
- Local Institution - 0031
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Querétaro
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Querétaro City, Querétaro, México, 76000
- Local Institution - 0065
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Querétaro City, Querétaro, México, 76090
- Local Institution - 0085
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San Luis Potosí
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San Luis Potosí City, San Luis Potosí, México, 78200
- Local Institution - 0105
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Auckland, Nueva Zelanda, 1023
- Local Institution - 0053
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Hamilton, Nueva Zelanda, 3204
- Local Institution - 0041
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Palmerston North, Nueva Zelanda, 4414
- Local Institution - 0078
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Biała Podlaska, Polonia, 21-500
- Local Institution - 0055
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Bydgoszcz, Polonia, 85-796
- Local Institution - 0062
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Gdansk, Polonia, 80-214
- Local Institution - 0083
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Krakow, Polonia, 30-688
- Local Institution - 0021
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Krakow, Polonia, 31-115
- Local Institution - 0098
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Poznan, Polonia, 60-569
- Local Institution - 0001
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Warsaw, Polonia, 02-781
- Local Institution - 0023
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Coimbra, Portugal, 3030-075
- Local Institution - 0050
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Lisbon, Portugal, 1500-650
- Local Institution - 0052
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Bucharest, Rumania, 022238
- Local Institution - 0024
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Cluj-Napoca, Rumania, 400132
- Local Institution - 0002
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Cluj-Napoca, Rumania, 400641
- Local Institution - 0040
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Craiova, Rumania, 200347
- Local Institution - 0016
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Chelyabinsk, Rusia, 454087
- SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
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Ivanovo, Rusia, 153040
- Ivanovo Regional Oncology Dispensary
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Moscow, Rusia, 125284
- Hertzen Moscow Oncology Research Center
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Nizghiy Novgorod, Rusia, 603000
- Local Institution
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Omsk, Rusia, 644013
- Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
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Saint Petersburg, Rusia, 197022
- LLC Eurocityclinic
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Ankara, Turquía (Türkiye), 06230
- Local Institution - 0026
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Ankara, Turquía (Türkiye), 06590
- Local Institution - 0097
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Istanbul, Turquía (Türkiye), 34098
- Local Institution - 0019
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Bagcilar
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Istanbul, Bagcilar, Turquía (Türkiye), 34284
- Local Institution - 0035
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histological confirmation of renal cell carcinoma (RCC) with a clear cell component, including participants who may also have sarcomatoid features
- Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC (Stage IV)
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria within 28 days prior to randomization
- Received no more than 2 prior systemic treatment regimens
- Intolerance or progression on or after the last treatment regimen received and within 6 months prior to randomization
- Karnofsky PS ≥ 70 at screening
- Must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
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Untreated, symptomatic central nervous system (CNS) metastases
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Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization
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Active, known, or suspected autoimmune disease
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Known human immunodeficiency virus (HIV) positive with an acquired immunodeficiency syndrome (AIDS) defining opportunistic infection within the last year, or a current CD4 count < 350 cells/μL. Participants with HIV are eligible if:
- They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization
- They continue on ART as clinically indicated while enrolled on study
- CD4 counts and viral load are monitored per standard of care by a local health care provider
- Inclusion of participants with HIV should be based on Investigator clinical judgment in consultation with the Medical Monitor NOTE: Testing for HIV must be performed at sites where mandated locally. HIV-positive participants must be excluded where mandated locally
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Serious or uncontrolled medical disorders including for example, active severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) infection within approximately 4 weeks prior to screening. In the case of prior SARS-CoV-2 infection, acute symptoms must have resolved based on investigator clinical judgment and, in consultation with Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment to be eligible
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Prior treatment with an programmed death receptor-1 (anti-PD-1), programmed death ligand-1 (anti-PD-L1), or cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
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Treatment with any live attenuated vaccine within 30 days of first study treatment
Other protocol-defined inclusion/exclusion criteria apply
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Brazo A
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Specified dose on specified days
Otros nombres:
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Comparador activo: Brazo B
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Specified dose on specified days
Otros nombres:
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Experimental: Brazo C
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Specified dose on specified days
Otros nombres:
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Experimental: Brazo D
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Specified dose on specified days
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale
Periodo de tiempo: Pre-dose (Day 1 to Day 28)
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Plasma samples were collected to assess the serum concentration. |
Pre-dose (Day 1 to Day 28)
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Adjusted Geometric Mean of Nivolumab Trough Serum Concentration at Steady State (Cminss) on Original Scale
Periodo de tiempo: Pre-dose (Day 1 to Day 28)
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Plasma samples were collected to assess the serum concentration. |
Pre-dose (Day 1 to Day 28)
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Objective Response Rate (ORR) Per BICR
Periodo de tiempo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
|
Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
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Trough Serum Concentration of Nivolumab at Day 28 (Cmind28)
Periodo de tiempo: Pre-dose at Day 28
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Blood samples were collected to assess serum concentration. |
Pre-dose at Day 28
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Maximum Serum Concentration of Nivolumab After the First Dose (Cmax1)
Periodo de tiempo: Post dose (Day 1)
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Blood samples were collected to assess serum concentration. |
Post dose (Day 1)
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Peak Serum Concentration of Nivolumab at Steady State (Cmaxss)
Periodo de tiempo: Pre-dose (Day 1 to Day 28)
|
Blood samples were collected to assess serum concentration. |
Pre-dose (Day 1 to Day 28)
|
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Time-averaged Serum Concentration of Nivolumab at Steady State (Cavgss)
Periodo de tiempo: Pre-dose (Day 1 to Day 28)
|
Blood samples were collected to assess serum concentration. |
Pre-dose (Day 1 to Day 28)
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Trough Serum Concentration of Nivolumab (Ctrough)
Periodo de tiempo: Pre-dose at Week 17
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Blood samples were collected to assess serum concentration. |
Pre-dose at Week 17
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Time to Maximum Serum Concentration of Nivolumab at Day 1 (Tmax1)
Periodo de tiempo: Post dose (Day 1)
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Blood samples were collected to assess serum concentration. |
Post dose (Day 1)
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Trough Serum Concentration of Nivolumab at Steady State (Cminss)
Periodo de tiempo: Pre dose (Day 1 to Day 28)
|
Blood samples were collected to assess serum concentration. |
Pre dose (Day 1 to Day 28)
|
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Number of Participants With Adverse Events, Serious Adverse Events, AEs Leading to Discontinuation and Death
Periodo de tiempo: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
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AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions, results in a congenital abnormality or birth defect, or is an important medical event that may not result in death, be life-threatening, or require hospitalization, but may require medical or surgical intervention to prevent any of the outcomes listed above. |
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
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Number of Participants With Grade 3/4 Laboratory Abnormalities
Periodo de tiempo: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
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Blood samples were collected for assessment of laboratory test results. All abnormalities were graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization. |
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
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Disease Control Rate (ORR) Per BICR
Periodo de tiempo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
|
Disease control rate (DCR) is defined as the percentage of participants who achieve a BOR of confirmed Complete Response (CR), confirmed Partial Response (PR), or stable disease (SD), based on BICR assessments (using RECIST 1.1) divided by the number of all randomized participants. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. |
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
|
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Time to Response (TTR) Per BICR
Periodo de tiempo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
|
Time to response (TTR) assessed by BICR is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
|
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Duration of Response (DoR) Per BICR
Periodo de tiempo: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
|
Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR is complete disappearance of all target lesions except nodal disease; all target nodes must decrease to normal size (short axis < 10 mm). PR is ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. Disease progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. |
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
|
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Overall Survival
Periodo de tiempo: From first dose to the date of death (up to approximately 26 months)
|
Overall survival is defined as the time from the first dosing date (or from randomization/on treatment) to the date of death from any cause. |
From first dose to the date of death (up to approximately 26 months)
|
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Number of Participants With Drug-Related Local Injection- or Infusion-Site Reactions
Periodo de tiempo: First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 27 months)
|
First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 27 months)
|
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Number of Participants With Incidence of Anti-nivolumab Antibodies
Periodo de tiempo: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
|
ADA Positive is a subject with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater [≥]than baseline positive titer) at any time after initiation of treatment. |
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: Bristol-Myers Squibb, Bristol-Myers Squibb
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Neoplasias Urológicas
- Carcinoma
- Neoplasias Renales
- Carcinoma De Célula Renal
- Aminoácidos, péptidos y proteínas
- Proteínas
- Anticuerpos, monoclonales, humanizados
- Anticuerpos, monoclonal
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Nivolumab
Otros números de identificación del estudio
Otros números de identificación del estudio
- CA209-67T
- 2020-003655-15 (Número EudraCT)
- U1111-1255-9514 (Identificador de registro: WHO)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Marco de tiempo para compartir IPD
See Plan Description
Criterios de acceso compartido de IPD
See Plan Description
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .