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皮下纳武单抗与静脉内纳武单抗在既往治疗过的晚期或已扩散肾透明细胞癌参与者中的研究 (CheckMate-67T)

2026年8月26日 更新者：Bristol-Myers Squibb

在既往接受过全身治疗的晚期或转移性透明细胞肾细胞癌参与者中，皮下注射纳武单抗与静脉注射纳武单抗的 3 期、开放标签、随机、非劣效性试验

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.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

681

阶段

  • 第三阶段

扩展访问

不再可用 查看扩展访问记录。

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 俄罗斯
      • Chelyabinsk、俄罗斯、454087
        • SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
      • Ivanovo、俄罗斯、153040
        • Ivanovo Regional Oncology Dispensary
      • Moscow、俄罗斯、125284
        • Hertzen Moscow Oncology Research Center
      • Nizghiy Novgorod、俄罗斯、603000
        • Local Institution
      • Omsk、俄罗斯、644013
        • Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
      • Saint Petersburg、俄罗斯、197022
        • LLC Eurocityclinic
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）、06230
        • Local Institution - 0026
      • Ankara、土耳其（türkiye）、06590
        • Local Institution - 0097
      • Istanbul、土耳其（türkiye）、34098
        • Local Institution - 0019
    • Bagcilar
      • Istanbul、Bagcilar、土耳其（türkiye）、34284
        • Local Institution - 0035
  • 墨西哥
    • Coahuila
      • Torreón、Coahuila、墨西哥、27010
        • Local Institution - 0101
    • Mexico City
      • Tlalpan、Mexico City、墨西哥、14080
        • Local Institution - 0089
    • Nuevo León
      • Monterrey、Nuevo León、墨西哥、64460
        • Local Institution - 0103
      • Monterrey、Nuevo León、墨西哥、64710
        • Local Institution - 0031
    • Querétaro
      • Querétaro City、Querétaro、墨西哥、76000
        • Local Institution - 0065
      • Querétaro City、Querétaro、墨西哥、76090
        • Local Institution - 0085
    • San Luis Potosí
      • San Luis Potosí City、San Luis Potosí、墨西哥、78200
        • Local Institution - 0105
  • 巴西
    • Paraná
      • Curitiba、Paraná、巴西、80520-174
        • Local Institution - 0064
    • Rio Grande do Sul
      • Ijuí、Rio Grande do Sul、巴西、98700-000
        • Local Institution - 0107
      • Porto Alegre、Rio Grande do Sul、巴西、91350-200
        • Local Institution - 0039
    • Rio de Janeiro
      • Rio de Janeiro、Rio de Janeiro、巴西、20230-130
        • Local Institution - 0090
    • São Paulo
      • Barretos、São Paulo、巴西、014784-000
        • Local Institution - 0071
      • São José do Rio Preto、São Paulo、巴西、15090-000
        • Local Institution - 0070
      • São Paulo、São Paulo、巴西、01246-000
        • Local Institution - 0081
      • São Paulo、São Paulo、巴西、01327-0001
        • Local Institution - 0096
  • 意大利
      • Cremona、意大利、26100
        • Local Institution - 0033
      • Florence、意大利、50134
        • Local Institution - 0008
      • Meldola、意大利、47014
        • Local Institution - 0027
      • Milan、意大利、20141
        • Local Institution - 0018
      • Milan、意大利、20133
        • Local Institution
      • Padova、意大利、35128
        • Local Institution - 0014
      • Parma、意大利、43126
        • Local Institution - 0082
      • Pavia、意大利、27100
        • Local Institution - 0092
      • Roma、意大利、00168
        • Local Institution - 0100
      • Rome、意大利、00152
        • Local Institution - 0091
      • Terni、意大利、05100
        • Local Institution - 0057
  • 捷克语
      • Brno、捷克语、656 53
        • Local Institution - 0063
      • Hradec Králové、捷克语、500 05
        • Local Institution - 0036
      • Olomouc、捷克语、77900
        • Local Institution - 0020
      • Ostrava、捷克语、708 52
        • Local Institution - 0099
      • Prague、捷克语、140 59
        • Local Institution - 0010
      • Praha 8 Liben、捷克语、18081
        • Local Institution - 0106
  • 新西兰
      • Auckland、新西兰、1023
        • Local Institution - 0053
      • Hamilton、新西兰、3204
        • Local Institution - 0041
      • Palmerston North、新西兰、4414
        • Local Institution - 0078
  • 智利
    • Araucania
      • Temuco、Araucania、智利
        • Local Institution - 0084
    • Santiago Metropolitan
      • Santiago、Santiago Metropolitan、智利
        • Local Institution - 0005
      • Santiago、Santiago Metropolitan、智利、7500653
        • Local Institution - 0104
      • Santiago、Santiago Metropolitan、智利、7500921
        • Local Institution - 0076
    • Valparaiso
      • Viña del Mar、Valparaiso、智利、2520598
        • Local Institution - 0077
  • 法国
      • Nice、法国、6189
        • Local Institution
      • Suresnes、法国、92151
        • Local Institution - 0051
      • Villejuif、法国、94800
        • Local Institution - 0068
  • 波兰
      • Biała Podlaska、波兰、21-500
        • Local Institution - 0055
      • Bydgoszcz、波兰、85-796
        • Local Institution - 0062
      • Gdansk、波兰、80-214
        • Local Institution - 0083
      • Krakow、波兰、30-688
        • Local Institution - 0021
      • Krakow、波兰、31-115
        • Local Institution - 0098
      • Poznan、波兰、60-569
        • Local Institution - 0001
      • Warsaw、波兰、02-781
        • Local Institution - 0023
  • 爱尔兰
    • Dublin
      • Tallaght、Dublin、爱尔兰
        • Local Institution - 0060
  • 罗马尼亚
      • Bucharest、罗马尼亚、022238
        • Local Institution - 0024
      • Cluj-Napoca、罗马尼亚、400132
        • Local Institution - 0002
      • Cluj-Napoca、罗马尼亚、400641
        • Local Institution - 0040
      • Craiova、罗马尼亚、200347
        • Local Institution - 0016
  • 美国
    • Illinois
      • Chicago、Illinois、美国、60611
        • Local Institution
    • New York
      • Buffalo、New York、美国、14263
        • Local Institution - 0025
    • Pennsylvania
      • West Reading、Pennsylvania、美国、19611
        • Local Institution - 0088
  • 芬兰
      • Tampere、芬兰、33521
        • Local Institution - 0017
  • 葡萄牙
      • Coimbra、葡萄牙、3030-075
        • Local Institution - 0050
      • Lisbon、葡萄牙、1500-650
        • Local Institution - 0052
  • 西班牙
      • Barcelona、西班牙、08003
        • Local Institution - 0048
      • Barcelona、西班牙、08035
        • Local Institution - 0102
      • Barcelona、西班牙、08041
        • Local Institution - 0049
      • Madrid、西班牙、28026
        • Local Institution - 0072
      • Madrid、西班牙、28033
        • Local Institution - 0067
      • Madrid、西班牙、28046
        • Local Institution - 0074
      • Madrid、西班牙、28050
        • Local Institution - 0075
      • Sabadell、西班牙、08208
        • Local Institution - 0032
      • Santander、西班牙、39008
        • Local Institution - 0086
      • Seville、西班牙、31013
        • Local Institution - 0059
  • 阿根廷
    • Buenos Aires
      • Buenos Aires、Buenos Aires、阿根廷、C1426ANZ
        • Local Institution - 0038
      • Capital Federal、Buenos Aires、阿根廷、C1419AHN
        • Local Institution - 0095
      • Mar del Plata、Buenos Aires、阿根廷、7600
        • Local Institution - 0058
      • Pergamino、Buenos Aires、阿根廷、B2700CPM
        • Local Institution - 0037
    • Córdoba Province
      • Parana、Córdoba Province、阿根廷、5000
        • Local Institution - 0079
      • Río Cuarto、Córdoba Province、阿根廷、5800
        • Local Institution - 0030
    • Río Negro Province
      • Viedma、Río Negro Province、阿根廷、R8500ACE
        • Local Institution - 0066
    • San Juan Province
      • San Juan、San Juan Province、阿根廷、J5402DIL
        • Local Institution - 0056

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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:

  • Untreated, symptomatic central nervous system (CNS) metastases

  • Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization

  • Active, known, or suspected autoimmune disease

  • 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:

    1. They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization
    2. They continue on ART as clinically indicated while enrolled on study
    3. CD4 counts and viral load are monitored per standard of care by a local health care provider
    4. 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

  • 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

  • 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

  • Treatment with any live attenuated vaccine within 30 days of first study treatment

Other protocol-defined inclusion/exclusion criteria apply

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：手臂A
生物：Nivolumab and rHuPH20

Specified dose on specified days

其他名称：
  • BMS-986298
有源比较器：B臂
生物：Nivolumab

Specified dose on specified days

其他名称：
  • BMS-936558
  • 欧狄沃
实验性的：C臂
生物：Nivolumab and rHuPH20

Specified dose on specified days

其他名称：
  • BMS-986298
实验性的：D臂
生物：Nivolumab and rHuPH20

Specified dose on specified days

其他名称：
  • BMS-986298

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale
大体时间：Pre-dose (Day 1 to Day 28)

Plasma samples were collected to assess the serum concentration.
Pre-dose (Day 1 to Day 28)
Adjusted Geometric Mean of Nivolumab Trough Serum Concentration at Steady State (Cminss) on Original Scale
大体时间：Pre-dose (Day 1 to Day 28)

Plasma samples were collected to assess the serum concentration.
Pre-dose (Day 1 to Day 28)

次要结果测量

结果测量
措施说明
大体时间
Objective Response Rate (ORR) Per BICR
大体时间：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)
Trough Serum Concentration of Nivolumab at Day 28 (Cmind28)
大体时间：Pre-dose at Day 28

Blood samples were collected to assess serum concentration.
Pre-dose at Day 28
Maximum Serum Concentration of Nivolumab After the First Dose (Cmax1)
大体时间：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)
大体时间：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)
大体时间：Pre-dose (Day 1 to Day 28)

Blood samples were collected to assess serum concentration.
Pre-dose (Day 1 to Day 28)
Trough Serum Concentration of Nivolumab (Ctrough)
大体时间：Pre-dose at Week 17

Blood samples were collected to assess serum concentration.
Pre-dose at Week 17
Time to Maximum Serum Concentration of Nivolumab at Day 1 (Tmax1)
大体时间：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)
大体时间：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
大体时间：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)
Number of Participants With Grade 3/4 Laboratory Abnormalities
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bristol-Myers Squibb

调查人员

  • 研究主任：Bristol-Myers Squibb、Bristol-Myers Squibb

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年5月21日

初级完成 (实际的)

2025年7月29日

研究完成 (估计的)

2027年5月10日

研究注册日期

首次提交

2021年3月16日

首先提交符合 QC 标准的

2021年3月19日

首次发布 (实际的)

2021年3月22日

研究记录更新

最后更新发布 (实际的)

2026年9月22日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CA209-67T
  • 2020-003655-15 (EudraCT编号)
  • U1111-1255-9514 (注册表标识符：WHO)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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

IPD 共享时间框架

See Plan Description

IPD 共享访问标准

See Plan Description

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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