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Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma (CheckMate 066)

2022年6月17日 更新者：Bristol-Myers Squibb

A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma

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)

418

阶段

  • 第三阶段

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
      • Aarhus、丹麦、8000
        • Aarhus Universitetshospital
      • Herlev、丹麦、2730
        • Herlev Hospital
      • Odense、丹麦、5000
        • Odense University Hospital
  • 以色列
      • Haifa、以色列、34362
        • Local Institution
      • Jerusalem、以色列、91120
        • Local Institution
      • Tel Hashomer、以色列、52621
        • Local Institution
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4N2
        • Tom Baker Cancer Centre
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 4E6
        • Local Institution - 0039
    • Nova Scotia
      • Halfax、Nova Scotia、加拿大、B3H 2Y9
        • Qe Ii Health Science Centre
    • Ontario
      • Toronto、Ontario、加拿大、M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto、Ontario、加拿大、M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal、Quebec、加拿大、H4A 3J1
        • Local Institution - 0040
  • 墨西哥
    • Distrito Federal
      • Mexico、Distrito Federal、墨西哥、03310
        • Local Institution
      • Tlalpan、Distrito Federal、墨西哥、14080
        • Local Institution
    • Guanajuato
      • Leon, Guanajato、Guanajuato、墨西哥、37000
        • Local Institution
    • Michoacan
      • Morelia、Michoacan、墨西哥、58240
        • Local Institution
  • 希腊
      • Athens、希腊、11527
        • Laiko Hospital
      • Neo Faliro、希腊、18547
        • Metropolitan Hospital
  • 德国
      • Essen、德国、45122
        • Local Institution
      • Gera、德国、07548
        • Local Institution
      • Goettingen、德国、37075
        • Local Institution
      • Heidelberg、德国、69120
        • Local Institution
      • Kiel、德国、24105
        • Local Institution
      • Koeln、德国、50937
        • Local Institution
      • Magdeburg、德国、39120
        • Local Institution
      • Mainz、德国、55131
        • Local Institution
      • Nuernberg、德国、90419
        • Local Institution
      • Recklinghausen、德国、45659
        • Local Institution
      • Tubingen、德国、72076
        • Local Institution
    • Bayern
      • Wuerzburg、Bayern、德国、97080
        • Local Institution
  • 意大利
      • Bari、意大利、70124
        • Local Institution
      • Bergamo、意大利、24127
        • Local Institution
      • Genova、意大利、16132
        • Local Institution
      • Meldola (fc)、意大利、47014
        • Local Institution
      • Milano、意大利、20141
        • Local Institution
      • Milano、意大利、20133
        • Local Institution
      • Napoli、意大利、80131
        • Local Institution
      • Padova、意大利、35128
        • Local Institution
      • Roma、意大利、00144
        • Local Institution
      • Siena、意大利、53100
        • Local Institution
  • 挪威
      • Oslo、挪威、0379
        • Local Institution
  • 智利
      • Santiago、智利、7630370
        • Local Institution
    • Metropolitana
      • Santiago、Metropolitana、智利
        • Local Institution
    • Valparaiso
      • Viña Del Mar、Valparaiso、智利
        • Local Institution
  • 法国
      • Bordeaux、法国、33075
        • Hôpital Saint André
      • Grenoble、法国、38043
        • Chu Grenoble - Hopital Albert Michallon
      • Lille、法国、59037
        • CHRU de Lille - Hopital Claude Huriez
      • Montpellier、法国、34295
        • Hôpital St Eloi
      • Paris、法国、75010
        • Hopital Saint Louis
      • Villejuif、法国、94805
        • Local Institution - 0013
  • 波兰
      • Gdansk、波兰、80-219
        • Local Institution
      • Lodz、波兰、93-513
        • Local Institution
      • Warszawa、波兰、02-781
        • Local Institution
  • 澳大利亚
    • New South Wales
      • Camperdown、New South Wales、澳大利亚、2050
        • Local Institution
      • Coffs Harbour、New South Wales、澳大利亚、2450
        • Coffs Harbour Health Campus
      • North Sydney、New South Wales、澳大利亚、2060
        • Local Institution - 0006
      • Westmead、New South Wales、澳大利亚、2145
        • Local Institution
    • Queensland
      • Greenslopes、Queensland、澳大利亚、4120
        • Greenslopes Private Hospital
      • Southport、Queensland、澳大利亚、4215
        • Local Institution
      • Woolloongabba、Queensland、澳大利亚、4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • Royal Adelaide Hospital
    • Victoria
      • Malvern、Victoria、澳大利亚、3144
        • Cabrini Hospital
  • 瑞典
      • Gothenberg、瑞典、413 45
        • Local Institution
      • Lund、瑞典、221 85
        • Local Institution
      • Umea、瑞典、901 85
        • Local Institution
  • 芬兰
      • Helsinki、芬兰、00290
        • Local Institution - 0035
  • 西班牙
      • Barcelona、西班牙、08036
        • Local Institution - 0056
      • Madrid、西班牙、28034
        • Local Institution
      • Madrid、西班牙、28033
        • Local Institution
      • Sevilla、西班牙、41009
        • Local Institution
      • Valencia、西班牙、46014
        • Local Institution
    • Guipuzcoa
      • San Sebastian、Guipuzcoa、西班牙、20014
        • Local Institution
  • 阿根廷
      • Buenos Aires、阿根廷、C1426ANZ
        • Instituto Medico Especialazado Alexander Fleming
      • Cordoba、阿根廷、5000
        • Instituto Oncologico de Cordoba
    • Distrito Federal
      • Buenos Aires、Distrito Federal、阿根廷、1121
        • Fundacion CIDEA

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:

  • Men and women ≥18 years of age
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as per the staging system of the American Joint Committee on Cancer
  • Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1
  • Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
  • Known BRAF wild-type, as per regionally acceptable V600 mutational status testing. BRAF mutant patients and those with indeterminate or unknown BRAF status are not permitted to randomize

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases
  • Ocular melanoma
  • Any active, known, or suspected autoimmune disease

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Nivolumab, 3 mg/kg
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may switch to nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
生物：BMS-936558 (Nivolumab)
药品：Placebo matching Dacarbazine
有源比较器：Dacarbazine, 1000 mg/m^2
Participants received dacarbazine, 1000 mg/m^2, solution administered IV every 3 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may cross-over to nivolumab open label treatment, either 3 mg/kg every 2 weeks or 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
药品：达卡巴嗪
生物：Placebo matching BMS-936558 (Nivolumab)

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
Overall Survival (OS)
大体时间：From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.
OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.
From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.
Overall Survival (OS) Rate
大体时间：From randomization to 6 months and or to 12 months
OS rate is calculated as the percentage of participants alive at the indicated timepoints
From randomization to 6 months and or to 12 months

次要结果测量

结果测量
措施说明
大体时间
Progression-free Survival (PFS)
大体时间：From date of randomization up to date of disease progression or death, up to approximately 84 months
Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were documented on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were documented on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were documented on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.
From date of randomization up to date of disease progression or death, up to approximately 84 months
Progression-free Survival (PFS) Rate
大体时间：From randomization to the specified timepoints, up to 84 months
The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.
From randomization to the specified timepoints, up to 84 months
Objective Response Rate (ORR)
大体时间：Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 94 months
ORR is defined as the percentage of participants with a best overall response of Response Evaluation Criteria in Solid Tumors (RECIST) defined complete response (CR) or partial response (PR). RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of ≥5 mm.
Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 94 months
Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level
大体时间：From date of randomization to date of disease progression or death, up to approximately 94 months
Overall Survival is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. PD-L1 expression level is defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC (immunohistochemistry) assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% (PD-L1 positive) versus patients with tumor PD-L1 expression <5% (PD-L1 negative). Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.
From date of randomization to date of disease progression or death, up to approximately 94 months
Change From Baseline in Health-related Quality of Life (HRQoL) Scores
大体时间：At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months
HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.
At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 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

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)

2013年1月18日

初级完成 (实际的)

2014年6月24日

研究完成 (实际的)

2021年5月14日

研究注册日期

首次提交

2012年11月2日

首先提交符合 QC 标准的

2012年11月2日

首次发布 (估计)

2012年11月6日

研究记录更新

最后更新发布 (实际的)

2022年7月12日

上次提交的符合 QC 标准的更新

2022年6月17日

最后验证

2022年6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

  • CA209-066
  • 2012-003718-16 (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

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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赞助者和合作者

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CROs in Kazakhstan

条件

罕见疾病

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膳食补充剂

赞助者/合作者

地点

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