Исследование подкожного ниволумаба по сравнению с внутривенным ниволумабом у участников с ранее леченным светлоклеточным почечно-клеточным раком, который прогрессирует или распространился (CheckMate-67T)
Фаза 3, открытое, рандомизированное исследование не меньшей эффективности подкожной формы ниволумаба по сравнению с внутривенным ниволумабом у участников с распространенным или метастатическим светлоклеточным почечно-клеточным раком, которые ранее получали системную терапию
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.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Расширенный доступ
Контакты и местонахождение
Места учебы
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Buenos Aires
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Buenos Aires, Buenos Aires, Аргентина, C1426ANZ
- Local Institution - 0038
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Capital Federal, Buenos Aires, Аргентина, C1419AHN
- Local Institution - 0095
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Mar del Plata, Buenos Aires, Аргентина, 7600
- Local Institution - 0058
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Pergamino, Buenos Aires, Аргентина, B2700CPM
- Local Institution - 0037
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Córdoba Province
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Parana, Córdoba Province, Аргентина, 5000
- Local Institution - 0079
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Río Cuarto, Córdoba Province, Аргентина, 5800
- Local Institution - 0030
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Río Negro Province
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Viedma, Río Negro Province, Аргентина, R8500ACE
- Local Institution - 0066
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San Juan Province
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San Juan, San Juan Province, Аргентина, J5402DIL
- Local Institution - 0056
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Paraná
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Curitiba, Paraná, Бразилия, 80520-174
- Local Institution - 0064
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, Бразилия, 98700-000
- Local Institution - 0107
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Porto Alegre, Rio Grande do Sul, Бразилия, 91350-200
- Local Institution - 0039
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, Бразилия, 20230-130
- Local Institution - 0090
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São Paulo
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Barretos, São Paulo, Бразилия, 014784-000
- Local Institution - 0071
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São José do Rio Preto, São Paulo, Бразилия, 15090-000
- Local Institution - 0070
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São Paulo, São Paulo, Бразилия, 01246-000
- Local Institution - 0081
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São Paulo, São Paulo, Бразилия, 01327-0001
- Local Institution - 0096
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Dublin
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Tallaght, Dublin, Ирландия
- Local Institution - 0060
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Barcelona, Испания, 08003
- Local Institution - 0048
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Barcelona, Испания, 08035
- Local Institution - 0102
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Barcelona, Испания, 08041
- Local Institution - 0049
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Madrid, Испания, 28026
- Local Institution - 0072
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Madrid, Испания, 28033
- Local Institution - 0067
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Madrid, Испания, 28046
- Local Institution - 0074
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Madrid, Испания, 28050
- Local Institution - 0075
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Sabadell, Испания, 08208
- Local Institution - 0032
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Santander, Испания, 39008
- Local Institution - 0086
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Seville, Испания, 31013
- Local Institution - 0059
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Cremona, Италия, 26100
- Local Institution - 0033
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Florence, Италия, 50134
- Local Institution - 0008
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Meldola, Италия, 47014
- Local Institution - 0027
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Milan, Италия, 20141
- Local Institution - 0018
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Milan, Италия, 20133
- Local Institution
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Padova, Италия, 35128
- Local Institution - 0014
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Parma, Италия, 43126
- Local Institution - 0082
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Pavia, Италия, 27100
- Local Institution - 0092
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Roma, Италия, 00168
- Local Institution - 0100
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Rome, Италия, 00152
- Local Institution - 0091
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Terni, Италия, 05100
- Local Institution - 0057
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Coahuila
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Torreón, Coahuila, Мексика, 27010
- Local Institution - 0101
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Mexico City
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Tlalpan, Mexico City, Мексика, 14080
- Local Institution - 0089
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Nuevo León
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Monterrey, Nuevo León, Мексика, 64460
- Local Institution - 0103
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Monterrey, Nuevo León, Мексика, 64710
- Local Institution - 0031
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Querétaro
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Querétaro City, Querétaro, Мексика, 76000
- Local Institution - 0065
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Querétaro City, Querétaro, Мексика, 76090
- Local Institution - 0085
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San Luis Potosí
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San Luis Potosí City, San Luis Potosí, Мексика, 78200
- Local Institution - 0105
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Auckland, Новая Зеландия, 1023
- Local Institution - 0053
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Hamilton, Новая Зеландия, 3204
- Local Institution - 0041
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Palmerston North, Новая Зеландия, 4414
- Local Institution - 0078
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Biała Podlaska, Польша, 21-500
- Local Institution - 0055
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Bydgoszcz, Польша, 85-796
- Local Institution - 0062
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Gdansk, Польша, 80-214
- Local Institution - 0083
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Krakow, Польша, 30-688
- Local Institution - 0021
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Krakow, Польша, 31-115
- Local Institution - 0098
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Poznan, Польша, 60-569
- Local Institution - 0001
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Warsaw, Польша, 02-781
- Local Institution - 0023
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Coimbra, Португалия, 3030-075
- Local Institution - 0050
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Lisbon, Португалия, 1500-650
- Local Institution - 0052
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Chelyabinsk, Россия, 454087
- SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
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Ivanovo, Россия, 153040
- Ivanovo Regional Oncology Dispensary
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Moscow, Россия, 125284
- Hertzen Moscow Oncology Research Center
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Nizghiy Novgorod, Россия, 603000
- Local Institution
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Omsk, Россия, 644013
- Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
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Saint Petersburg, Россия, 197022
- LLC Eurocityclinic
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Bucharest, Румыния, 022238
- Local Institution - 0024
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Cluj-Napoca, Румыния, 400132
- Local Institution - 0002
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Cluj-Napoca, Румыния, 400641
- Local Institution - 0040
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Craiova, Румыния, 200347
- Local Institution - 0016
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60611
- Local Institution
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New York
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Buffalo, New York, Соединенные Штаты, 14263
- Local Institution - 0025
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Pennsylvania
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West Reading, Pennsylvania, Соединенные Штаты, 19611
- Local Institution - 0088
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Ankara, Турция (Туркие), 06230
- Local Institution - 0026
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Ankara, Турция (Туркие), 06590
- Local Institution - 0097
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Istanbul, Турция (Туркие), 34098
- Local Institution - 0019
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Bagcilar
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Istanbul, Bagcilar, Турция (Туркие), 34284
- Local Institution - 0035
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Tampere, Финляндия, 33521
- Local Institution - 0017
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Nice, Франция, 6189
- Local Institution
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Suresnes, Франция, 92151
- Local Institution - 0051
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Villejuif, Франция, 94800
- Local Institution - 0068
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Brno, Чехия, 656 53
- Local Institution - 0063
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Hradec Králové, Чехия, 500 05
- Local Institution - 0036
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Olomouc, Чехия, 77900
- Local Institution - 0020
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Ostrava, Чехия, 708 52
- Local Institution - 0099
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Prague, Чехия, 140 59
- Local Institution - 0010
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Praha 8 Liben, Чехия, 18081
- Local Institution - 0106
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Araucania
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Temuco, Araucania, Чили
- Local Institution - 0084
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Чили
- Local Institution - 0005
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Santiago, Santiago Metropolitan, Чили, 7500653
- Local Institution - 0104
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Santiago, Santiago Metropolitan, Чили, 7500921
- Local Institution - 0076
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Valparaiso
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Viña del Mar, Valparaiso, Чили, 2520598
- Local Institution - 0077
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Рука А
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Specified dose on specified days
Другие имена:
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Активный компаратор: Рука Б
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Specified dose on specified days
Другие имена:
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Экспериментальный: Рука С
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Specified dose on specified days
Другие имена:
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Экспериментальный: Рука Д
|
Specified dose on specified days
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale
Временное ограничение: Pre-dose (Day 1 to Day 28)
|
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
Временное ограничение: Pre-dose (Day 1 to Day 28)
|
Plasma samples were collected to assess the serum concentration. |
Pre-dose (Day 1 to Day 28)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Objective Response Rate (ORR) Per BICR
Временное ограничение: 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)
Временное ограничение: Pre-dose at Day 28
|
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)
Временное ограничение: Post dose (Day 1)
|
Blood samples were collected to assess serum concentration. |
Post dose (Day 1)
|
|
Peak Serum Concentration of Nivolumab at Steady State (Cmaxss)
Временное ограничение: Pre-dose (Day 1 to Day 28)
|
Blood samples were collected to assess serum concentration. |
Pre-dose (Day 1 to Day 28)
|
|
Time-averaged Serum Concentration of Nivolumab at Steady State (Cavgss)
Временное ограничение: 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)
Временное ограничение: Pre-dose at Week 17
|
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)
Временное ограничение: Post dose (Day 1)
|
Blood samples were collected to assess serum concentration. |
Post dose (Day 1)
|
|
Trough Serum Concentration of Nivolumab at Steady State (Cminss)
Временное ограничение: Pre dose (Day 1 to Day 28)
|
Blood samples were collected to assess serum concentration. |
Pre dose (Day 1 to Day 28)
|
|
Number of Participants With Adverse Events, Serious Adverse Events, AEs Leading to Discontinuation and Death
Временное ограничение: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
|
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
Временное ограничение: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
|
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)
|
|
Disease Control Rate (ORR) Per BICR
Временное ограничение: 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)
|
|
Time to Response (TTR) Per BICR
Временное ограничение: 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)
|
|
Duration of Response (DoR) Per BICR
Временное ограничение: 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)
|
|
Overall Survival
Временное ограничение: 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)
|
|
Number of Participants With Drug-Related Local Injection- or Infusion-Site Reactions
Временное ограничение: 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)
|
|
|
Number of Participants With Incidence of Anti-nivolumab Antibodies
Временное ограничение: 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)
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Bristol-Myers Squibb, Bristol-Myers Squibb
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Урогенитальные новообразования
- Новообразования по локализации
- Новообразования
- Мужские мочеполовые заболевания
- Заболевания почек
- Урологические заболевания
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Новообразования по гистологическому типу
- Новообразования железистые и эпителиальные
- Аденокарцинома
- Урологические новообразования
- Карцинома
- Новообразования почек
- Карцинома, почечно-клеточная
- Аминокислоты, пептиды и белки
- Белки
- Антитела, моноклональные, гуманизированные
- Антитела, моноклональные
- Антитела
- Иммуноглобулины
- Иммунопротеины
- Белки крови
- Сывороточные глобулины
- Глобулины
- Ниволумаб
Другие идентификационные номера исследования
- CA209-67T
- 2020-003655-15 (Номер EudraCT)
- U1111-1255-9514 (Идентификатор реестра: WHO)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана 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
Сроки обмена IPD
See Plan Description
Критерии совместного доступа к IPD
See Plan Description
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .