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An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC (Checkmate 171)

2022年10月17日 更新者：Bristol-Myers Squibb
The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

812

阶段

  • 阶段2

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

  • 丹麦
      • Aalborg、丹麦、9000
        • Local Institution - 0021
      • Herlev、丹麦、2730
        • Local Institution - 0020
    • South Denmark
      • Odense、South Denmark、丹麦、5000
        • Local Institution - 0173
  • 俄罗斯联邦
    • Leningradskaya Oblast
      • Saint Petersburg、Leningradskaya Oblast、俄罗斯联邦、197758
        • Local Institution - 0100
    • Moskva
      • Moscow、Moskva、俄罗斯联邦、115478
        • Local Institution - 0160
    • Sankt-Peterburg
      • St. Petersburg、Sankt-Peterburg、俄罗斯联邦、198255
        • Local Institution - 0099
  • 匈牙利
      • Budapest、匈牙利、1121
        • Local Institution - 0053
      • Budapest、匈牙利、1125
        • Local Institution - 0347
      • Debrecen、匈牙利、4032
        • Local Institution - 0178
    • Baranya
      • Pécs、Baranya、匈牙利、7624
        • Local Institution - 0054
  • 奥地利
      • Salzburg、奥地利、5020
        • Local Institution - 0003
      • Wien、奥地利、1140
        • Local Institution - 0005
    • Oberösterreich
      • Wels、Oberösterreich、奥地利、4600
        • Local Institution - 0002
  • 希腊
      • Athens、希腊、11527
        • Local Institution - 0051
      • Heraklion、希腊、71110
        • Local Institution - 0052
      • Nea Kifisia Athens、希腊、14564
        • Local Institution - 0177
      • Patras、希腊、26504
        • Local Institution - 0148
      • Thessaloniki、希腊、57010
        • Local Institution - 0147
  • 波兰
      • Gdansk、波兰、80-214
        • Local Institution - 0086
      • Lodz、波兰、90-302
        • Local Institution - 0088
      • Warszawa、波兰、04-141
        • Local Institution - 0089
    • Slaskie
      • Gliwice、Slaskie、波兰、44-100
        • Local Institution - 0158
      • Zabrze、Slaskie、波兰、41-803
        • Local Institution - 0184
    • Wielkopolskie
      • Poznan、Wielkopolskie、波兰、60-693
        • Local Institution - 0087
  • 爱尔兰
      • Dublin 8、爱尔兰
        • Local Institution - 0056
      • Galway、爱尔兰、ST4 6QG
        • Local Institution - 0058
      • Tullamore, Offaly、爱尔兰
        • Local Institution - 0349
  • 瑞典
      • Linköping、瑞典、581 85
        • Local Institution - 0348
      • Lund、瑞典、22185
        • Local Institution - 0342
      • Stockholm、瑞典、171 76
        • Local Institution - 0120
    • Orebro Lan
      • Örebro、Orebro Lan、瑞典、SE-70185
        • Local Institution - 0339
    • Stockholms Lan
      • Stockholm、Stockholms Lan、瑞典、17176
        • Local Institution - 0346
    • Vastra Gotalands Lan
      • Goteborg、Vastra Gotalands Lan、瑞典、41345
        • Local Institution - 0193
  • 罗马尼亚
      • Bucharest、罗马尼亚、022328
        • Local Institution - 0095
      • Bucharest、罗马尼亚、030171
        • Local Institution - 0096
      • Cluj Napoca、罗马尼亚、400015
        • Local Institution - 0097
    • Bihor
      • Oradea、Bihor、罗马尼亚、410469
        • Local Institution - 0192
    • Cluj
      • Cluj-Napoca、Cluj、罗马尼亚、400058
        • Local Institution - 0098
    • Timis
      • Timisoara、Timis、罗马尼亚、300167
        • Local Institution - 0187
  • 芬兰
      • Pori、芬兰、FI-28500
        • Local Institution - 0023
    • Pohjois-Pohjanmaa
      • Oulu、Pohjois-Pohjanmaa、芬兰、90230
        • Local Institution - 0022
  • 英国
      • Bebington、英国、CH63 4JY
        • Local Institution - 0171
      • Bodelwyddan, Rhyl、英国、LL18 5UJ
        • Local Institution - 0340
      • Bradford、英国、BD9 6RJ
        • Local Institution - 0344
      • Bristol、英国、BS2 8ED
        • Local Institution - 0190
      • Cardiff、英国、CF14 2TL
        • Local Institution - 0133
      • Cottingham、英国、HU16 5JQ
        • Local Institution - 0126
      • London、英国、W1T 7HA
        • Local Institution - 0165
      • London、英国、W6 8RF
        • Local Institution - 0169
      • Northwood、英国、HA6 2RN
        • Local Institution - 0194
      • Plymouth、英国、PL6 8DH
        • Local Institution - 0166
      • Sheffield、英国、S10 5SJ
        • Local Institution - 0124
      • Sutton、英国、SM2 5PT
        • Local Institution - 0189
      • West Midlands、英国、CV2 2DX
        • Local Institution - 0338
    • Aberdeen CITY
      • Aberdeen、Aberdeen CITY、英国、AB25 2ZN
        • Local Institution - 0345
    • Greater London
      • London、Greater London、英国、N18 1QX
        • Local Institution - 0127
    • Greater Manchester
      • Manchester、Greater Manchester、英国、M20 4BX
        • Local Institution - 0191
    • Hampshire
      • Southampton、Hampshire、英国、SO16 6YD
        • Local Institution - 0131
    • Kent
      • Maidstone、Kent、英国、ME16 9QQ
        • Local Institution - 0128
    • Lanarkshire
      • Glasgow、Lanarkshire、英国、G12 0YN
        • Local Institution - 0195
    • Lancashire
      • Preston、Lancashire、英国、PR2 9HT
        • Local Institution - 0132
    • Leicestershire
      • Leicester、Leicestershire、英国、LE1 5WW
        • Local Institution - 0167
    • Surrey
      • Sutton、Surrey、英国、SM2 5PT
        • Local Institution - 0196
  • 葡萄牙
      • Coimbra、葡萄牙、3000-602
        • Local Institution - 0094
      • Lisboa、葡萄牙、1099-023
        • Local Institution - 0093
      • Lisboa、葡萄牙、1769-001
        • Local Institution - 0090
      • Porto、葡萄牙、4099-001
        • Local Institution - 0092
      • Porto、葡萄牙、4200-072
        • Local Institution - 0091
      • Porto、葡萄牙、4200-319
        • Local Institution - 0159
  • 西班牙
      • A Coruna、西班牙、15006
        • Local Institution - 0104
      • Alicante、西班牙、03010
        • Local Institution - 0119
      • Barcelona、西班牙、08036
        • Local Institution - 0162
      • Barcelona、西班牙、08916
        • Local Institution - 0112
      • Barcelona、西班牙、8028
        • Local Institution - 0111
      • Barcelona、西班牙、8035
        • Local Institution - 0110
      • Burgos、西班牙、09006
        • Local Institution - 0108
      • Granada、西班牙、18014
        • Local Institution - 0103
      • Madrid、西班牙、28034
        • Local Institution - 0114
      • Madrid、西班牙、28040
        • Local Institution - 0117
      • Madrid、西班牙、28041
        • Local Institution - 0116
      • Madrid、西班牙、28046
        • Local Institution - 0105
      • Malaga、西班牙、29010
        • Local Institution - 0106
      • Palma de Mallorca、西班牙、07198
        • Local Institution - 0113
      • Seville、西班牙、41013
        • Local Institution - 0118
      • Valencia、西班牙、46010
        • Local Institution - 0161
      • Valencia、西班牙、46026
        • Local Institution - 0102
      • Zaragoza、西班牙、50009
        • Local Institution - 0163
    • Asturias
      • Oviedo、Asturias、西班牙、33006
        • Local Institution - 0337
    • Cantabria
      • Santander、Cantabria、西班牙、39008
        • Local Institution - 0109
    • Santa Cruz De Tenerife
      • La Laguna、Santa Cruz De Tenerife、西班牙、38320
        • Local Institution - 0107

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 BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • ECOG Status: PS 0-1 & PS 2
  • Subjects with histologically or cytologically-documented SqNSCLC
  • Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen
  • Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria
  • Subjects with treated or asymptomatic CNS metastases
  • Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration
  • Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab
  • Males and Females, ages 18 or older

Exclusion Criteria:

  • Subjects with untreated, symptomatic CNS metastases
  • Subjects with carcinomatous meningitis
  • Subjects with active, known or suspected autoimmune disease.
  • Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.

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：其他
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Cohort A: Treatment - Nivolumab
Nivolumab IV infusion
药品：纳武单抗

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
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
大体时间：From first dose to time of analysis of primary endpoint (approximately up to 34 months)
The total number of participants with high grade treatment related select adverse events.
From first dose to time of analysis of primary endpoint (approximately up to 34 months)

次要结果测量

结果测量
措施说明
大体时间
Number of Participants With High Grade Select Adverse Events
大体时间：From first dose up to 100 days post last dose (up to 76 months)
The total number of participants with high grade select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
From first dose up to 100 days post last dose (up to 76 months)
Median Time to Onset of Any Grade Select Adverse Events
大体时间：From first dose up to 100 days post last dose (up to approximately 65 months)
Median Time to onset of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
From first dose up to 100 days post last dose (up to approximately 65 months)
Median Time to Resolution of Any Grade Select Adverse Events
大体时间：From first dose to up to 100 days post last dose (up to approximately 45 months)
Median time to resolution of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
From first dose to up to 100 days post last dose (up to approximately 45 months)
Overall Survival
大体时间：From the first dosing up to the date of death (up to approximately 76 months)
Overall Survival (OS) is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug.
From the first dosing up to the date of death (up to approximately 76 months)
Objective Response Rate (ORR)
大体时间：From first dose up to last dose (up to approximately 76 months)
ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions; PR is defined by at least a 30% decrease in the sum of the longest diameter of target lesions. ORR as assessed by the investigator will be reported.
From first dose up to last dose (up to approximately 76 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

合作者

PPD

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)

2015年4月29日

初级完成 (实际的)

2018年3月7日

研究完成 (实际的)

2021年8月27日

研究注册日期

首次提交

2015年4月1日

首先提交符合 QC 标准的

2015年4月3日

首次发布 (估计)

2015年4月6日

研究记录更新

最后更新发布 (实际的)

2022年11月14日

上次提交的符合 QC 标准的更新

2022年10月17日

最后验证

2022年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CA209-171
  • 2014-001285-10 (EudraCT编号)

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

在美国制造并从美国出口的产品

是的

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.

非小细胞肺癌的临床试验

纳武单抗的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Kosovo

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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