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Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

2014年10月24日 更新者：Bristol-Myers Squibb

A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo

The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine

研究概览

地位

完全的

条件

干预/治疗

详细说明

For the extension phase:

Allocation: single arm study; Masking: open label; Intervention Model: Single Group

研究类型

介入性

注册 (实际的)

681

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

  • 乌克兰
      • Cherkassy、乌克兰、18009
        • Local Institution
      • Dnepropetrovsk、乌克兰、49044
        • Local Institution
      • Lviv、乌克兰、79031
        • Local Institution
      • Uzhgorod、乌克兰、88000
        • Local Institution
  • 以色列
      • Jerusalem、以色列、91120
        • Local Institution
      • Tel Aviv、以色列、64239
        • Local Institution
  • 俄罗斯联邦
      • Moscow、俄罗斯联邦、115478
        • Local Institution
      • Moscow、俄罗斯联邦、105229
        • Local Institution
      • Murmansk、俄罗斯联邦、183047
        • Local Institution
      • Ryazan、俄罗斯联邦、390011
        • Local Institution
      • Samara、俄罗斯联邦、443066
        • Local Institution
      • St Petersburg、俄罗斯联邦、198255
        • Local Institution
      • St.-Petersburg、俄罗斯联邦、191104
        • Local Institution
      • Stavropol、俄罗斯联邦、355047
        • Local Institution
    • Stavropol
      • Pyatigorsk、Stavropol、俄罗斯联邦、357502
        • Local Institution
  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 1Z2
        • Local Institution
    • Quebec
      • Montreal、Quebec、加拿大、H3T 1E2
        • Local Institution
      • Montreal、Quebec、加拿大、H1T 2W4
        • Local Institution
    • Saskatchewan
      • Saskatoon、Saskatchewan、加拿大、S7N 4H4
        • Local Institution
  • 匈牙利
      • Kaposyar、匈牙利、7400
        • Local Institution
  • 南非
      • Johannesburg、南非、2199
        • Local Institution
    • Eastern Cape
      • Port Elizabeth、Eastern Cape、南非、6000
        • Local Institution
    • Gauteng
      • Groenkloof、Gauteng、南非、0181
        • Local Institution
      • Pretoria、Gauteng、南非、0041
        • Local Institution
      • Saxonworld、Gauteng、南非、2196
        • Local Institution
    • Western Cape
      • Cape Town、Western Cape、南非、7570
        • Local Institution
  • 奥地利
      • Vienna、奥地利、1090
        • Local Institution
  • 巴西
      • Sao Paulo、巴西、01508-010
        • Local Institution
    • Ceara
      • Fortaleza、Ceara、巴西、60430-230
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre、Rio Grande Do Sul、巴西、90050-170
        • Local Institution
      • Porto Alegre, Rs、Rio Grande Do Sul、巴西、90610-000
        • Local Institution
  • 德国
      • Berlin、德国、12200
        • Local Institution
      • Heidelberg、德国、69120
        • Local Institution
      • Jena、德国、07740
        • Local Institution
      • Kiel、德国、24105
        • Local Institution
      • Mannheim、德国、68167
        • Local Institution
      • Muenchen、德国、81675
        • Local Institution
      • Tubingen、德国、72076
        • Local Institution
  • 意大利
      • Genova、意大利、16128
        • Local Institution
      • Milano、意大利、20141
        • Local Institution
      • Napoli、意大利、80131
        • Local Institution
      • Padova、意大利、35128
        • Local Institution
      • Ragusa、意大利、97100
        • Local Institution
      • Rome、意大利、00144
        • Local Institution
      • Siena、意大利、53100
        • Local Institution
  • 挪威
    • Oslo
      • Montebello、Oslo、挪威、0310
        • Local Institution
  • 捷克共和国
      • Olomouc、捷克共和国、775 20
        • Local Institution
      • Praha、捷克共和国、128 08
        • Local Institution
  • 智利
      • Santiago、智利
        • Local Institution
  • 比利时
      • Brasschaat、比利时、2930
        • Local Institution
      • Brussels、比利时、1200
        • Local Institution
      • Edegem、比利时、B-2650
        • Local Institution
      • Gent、比利时、9000
        • Local Institution
  • 法国
      • Bordeaux、法国、33075
        • Local Institution
      • Marseille、法国、13009
        • Local Institution
      • Paris、法国、75010
        • Local Institution
      • Pierre Benite、法国、69495
        • Local Institution
      • Villejuif、法国、94805
        • Local Institution
    • Cedex
      • Brest、Cedex、法国、29200
        • Local Institution
    • Cedex 1
      • Nantes、Cedex 1、法国、44093
        • Local Institution
    • Cedex 2
      • Saint Etienne、Cedex 2、法国、42055
        • Local Institution
  • 波兰
      • Gdansk、波兰、80-219
        • Local Institution
      • Lodz、波兰、93-509
        • Local Institution
      • Lublin、波兰、20-090
        • Local Institution
      • Poznan、波兰、61-866
        • Local Institution
      • Wroclaw、波兰、51-124
        • Local Institution
  • 澳大利亚
    • New South Wales
      • Coffs Harbour、New South Wales、澳大利亚、2450
        • Local Institution
      • Newcastle、New South Wales、澳大利亚、2300
        • Local Institution
      • Port Macquarie、New South Wales、澳大利亚、2444
        • Local Institution
    • Queensland
      • South Brisbane、Queensland、澳大利亚、4101
        • Local Institution
    • Victoria
      • Box Hill、Victoria、澳大利亚、3128
        • Local Institution
  • 爱尔兰
      • Cork、爱尔兰
        • Local Institution
      • Galway、爱尔兰
        • Local Institution
    • Dublin 4
      • Dublin、Dublin 4、爱尔兰
        • Local Institution
  • 瑞士
      • Basel、瑞士、CH-4031
        • Local Institution
      • Geneva、瑞士、1211
        • Local Institution
  • 美国
    • California
      • Anaheim、California、美国、92801
        • Pacific Cancer Medical Center
      • La Verne、California、美国、91750
        • Wilshire Oncology Medical Group Inc
      • Los Angeles、California、美国、90025
        • The Angeles Clinic and Research Institute
      • Palm Springs、California、美国、92262
        • Comprehensive Cancer Center
      • San Diego、California、美国、92123
        • Sharp Clinical Oncology Research
    • Connecticut
      • Hartford、Connecticut、美国、06105
        • Saint Francis Hospital and Medical Center
      • Stamford、Connecticut、美国、06902-3628
        • Hematology Oncology, P.C.
    • Florida
      • Jacksonville、Florida、美国、32256
        • Cancer Specialists Of North Florida Beaches
      • Orlando、Florida、美国、32806
        • Orlando Health, Inc. M.D. Anderson Cancer Center Orlando
      • Port Saint Lucie、Florida、美国、34952
        • Hematology Oncology Associates of the Treasure Coast
    • Illinois
      • Chicago、Illinois、美国、60637
        • University of Chicago
      • Normal、Illinois、美国、61761
        • Mid-Illinois Hematology/Oncology Associates, Ltd.
      • Park Ridge、Illinois、美国、60068
        • Oncology Specialists, SC
    • Indiana
      • Fishers、Indiana、美国、46037
        • Central Indiana Cancer Centers
      • Indianapolis、Indiana、美国、46202
        • Indiana University Cancer Center
    • Kansas
      • Hutchinson、Kansas、美国、67502
        • Hutchinson Clinic, Pa
    • Kentucky
      • Hazard、Kentucky、美国、41701
        • Kentucky Cancer Clinic
    • Maryland
      • Baltimore、Maryland、美国、21215
        • Sinai Hospital of Baltimore
      • Baltimore、Maryland、美国、21204
        • Greater Baltimore Medical Center
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Dana Farber Cancer Institute
    • Missouri
      • Columbia、Missouri、美国、65203
        • Ellis Fischel Cancer Center
      • Saint Joseph、Missouri、美国、64507
        • St Joseph Oncology Inc
    • New Mexico
      • Albuquerque、New Mexico、美国、87106
        • University of New Mexico Cancer Center
    • New York
      • New York、New York、美国、10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Charlotte、North Carolina、美国、28204
        • Blumenthal Cancer Center
    • Oregon
      • Portland、Oregon、美国、97213
        • Providence Portland Medical Center
    • Pennsylvania
      • Bethlehem、Pennsylvania、美国、18015
        • St. Luke's Hospital & Health Network
    • South Carolina
      • Mount Pleasant、South Carolina、美国、29464
        • Lowcountry Hematology & Oncology, Pa
    • Tennessee
      • Knoxville、Tennessee、美国、37916
        • Thompson Cancer Survival Center
      • Nashville、Tennessee、美国、37232
        • Vanderbilt-Ingram Cancer Ctr
    • Texas
      • Lubbock、Texas、美国、79410
        • Joe Arrington Cancer Research and Treatment Center
    • Virginia
      • Richmond、Virginia、美国、23226
        • Virginia Cancer Institute
  • 英国
    • Avon
      • Bristol、Avon、英国、BS2 8ED
        • Local Institution
    • Dorset
      • Poole、Dorset、英国、BH15 2JB
        • Local Institution
    • Essex
      • Chelmsford、Essex、英国、CM1 7ET
        • Local Institution
    • Greater London
      • London、Greater London、英国、SW3 6JJ
        • Local Institution
    • Merseyside
      • Wirral、Merseyside、英国、CH63 3JY
        • Local Institution
    • Surrey
      • Guildford、Surrey、英国、GU2 7XX
        • Local Institution
  • 荷兰
      • Eindhoven、荷兰、5623 EJ
        • Local Institution
      • Hv Amsterdam、荷兰、1081
        • Local Institution
      • Wurzburg、荷兰、97080
        • Local Institution
  • 葡萄牙
      • Lisboa、葡萄牙、1099-023
        • Local Institution
  • 西班牙
      • Barcelona、西班牙、08036
        • Local Institution
      • Canarias、西班牙、38320
        • Local Institution
      • Valencia、西班牙、46014
        • Local Institution
      • Zaragoza、西班牙、50009
        • Local Institution
  • 阿根廷
      • Buenos Aires、阿根廷、C1426ANZ
        • Local Institution
      • Buenos Aires、阿根廷、C1408INH
        • Local Institution
      • Buenos Aires、阿根廷、1185
        • Local Institution
      • Cordoba、阿根廷、X5000AAI
        • Local Institution
      • Santa Fe、阿根廷、S3000FFU
        • Local Institution

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

Inclusion Criteria:

  • Informed Consent
  • Measurable Disease
  • Eastern Cooperative Oncology Group (ECOG) 0 or 1
  • Lab / imaging requirements
  • Neg for Human Immunodeficiency Virus (HIV), Hepatitis B (HepB), C
  • Men and Women > 18 years (16 were allowable)
  • Prior therapy restriction (adjuvant only)

Exclusion:

  • Pregnant / nursing
  • Inadequate contraception
  • Brain metastasis
  • Primary ocular or mucosal melanoma

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：Arm A: Ipilimumab and Dacarbazine
In Maintenance phase: Ipilimumab will be continued. Dacarbazine was given up to Week 22 and is not given in the Maintenance phase
药品：Ipilimumab

Intravenous solution; intravenous; 10mg/kg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24, until disease progression, unacceptable toxicity or withdrawal of consent

In Maintenance phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression

其他名称：
  • BMS-734016
  • MDX-010
药品：Dacarbazine
Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent
有源比较器：Arm B: Placebo and Dacarbazine
药品：Dacarbazine
Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent
药品：Placebo
Intravenous solution; intravenous; 0 mg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24; until disease progression, unacceptable toxicity or withdrawal of consent

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：Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months
OS was defined as the time from the date of randomization until the date of death. Analysis of OS was to be done once 416 deaths had occurred (primary endpoint). However, analysis occurred at 414 deaths (February 7, 2011), due to operational timing of the study. Median number of months of OS and associated confidence interval calculated using the method of Brookmeyer and Crowley.
Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months

次要结果测量

结果测量
措施说明
大体时间
Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years
大体时间：Date of randomization to 3 years following randomization
The survival rate (percentage of participants alive) was defined as the probability that a participant is alive at 1 year (or 18 months, 2 years, or 3 years) following randomization and was estimated via the Kaplan-Meier method.
Date of randomization to 3 years following randomization
Disease Control Rate (DCR)
大体时间：First dose to last tumor assessment prior to subsequent therapy at data cutoff for Primary Endpoint (approximately 5 years)
DCR=number whose best overall response (BOR) was partial response (PR), complete response (CR) or stable disease (SD), divided by all randomized participants (unevaluable participants included). Independent review committee assessment. BOR=date of first dose to last tumor assessment prior to subsequent cancer therapy (including tumor resection, excluding palliative local radiotherapy). Modified World Health Organization criteria: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline; SD=neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD; PD=at least 25% increase in sum of products of all index lesions and/or appearance of any new lesions; nonindex lesions: appearance of any new lesions and/or unequivocal progression of nonindex lesions.
First dose to last tumor assessment prior to subsequent therapy at data cutoff for Primary Endpoint (approximately 5 years)
Median Number of Months of Progression-free Survival (PFS)
大体时间：Randomization to date of progression or death to approximately 5 years
PFS=time between randomization and date of progression or death, whichever occurs first. Participants who died without reported prior progression were considered to have progressed on date of death. For those alive and not progressed, PFS was censored on date of last evaluable tumor assessment (TA). Those who have not died and have no recorded postbaseline TA were censored at randomization. Those who died without any recorded postbaseline TA were considered to have progressed on date of death. Evaluation was conducted by both investigator and an independent review committee (IRC), who assessed radiologic imaging studies, photographs of skin lesions, and clinical data. Progressive disease defined using modified criteria of the World Health Organization: demonstration of at least a 25% increase in the sum of products of all index lesions or the appearance of any new lesions. For nonindex lesions: appearance of any new lesions or unequivocal progression of nonindex lesions.
Randomization to date of progression or death to approximately 5 years
Progression-free Survival (PFS) Rate Truncated at Week 12
大体时间：Day 78
PFS rate=probability patient was progression-free at Day 78, calculated as total patients receiving treatment and with an overall response of stable disease (SD), partial response (PR), or complete response (CR) at Week 12, divided by total patients. For those alive and not progressed at or before Week 12, PFS censored on date of last evaluable tumor assessment (TA) at or before Week 12. Those with an assessment of PD prior to Week 12 and subsequent assessment of SD, PR, or CR at Week 12 were called progression-free at Week 12. Those with no recorded postbaseline TA dated on or before Day 109, and who had not died on or before Day 109, were censored at randomization. PD=at least 25% increase in sum of products of all index lesions or appearance of any new lesions. Both an investigator and independent review committee (IRC) assessed radiologic imaging studies, photographs of skin lesions, and clinical data. IRC assessment was considered primary over that of the investigators.
Day 78
Best Overall Response Rate (BORR)
大体时间：First dose to last tumor assessment at data cutoff for primary endpoint (approximately 5 years)
BORR=number with Best Overall Response (BOR) of complete response (CR) or partial response (PR), divided by total number of randomized patients. BOR=date of first dose to the last tumor assessment prior to subsequent cancer therapy (including tumor resection surgery but excluding palliative local radiotherapy for bone lesions). Independent review committee assessment. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions; no evidence of progressive disease; PR=50% or greater decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline. Immune-related (ir) response criteria (irRC) assess tumor response in patients on immunotherapy: irCR=disappearance of all lesions in 2 consecutive observations at least 4 weeks apart; irPR=50% or greater decrease in total measureable tumor burden compared with peak in 2 observations at least 4 weeks apart.
First dose to last tumor assessment at data cutoff for primary endpoint (approximately 5 years)
Duration of Response (DOR): Randomized Participants With Response of Complete Response (CR) or Partial Response (PR)
大体时间：Day of CR or PR to day of PD or death up to data cutoff for primary endpoint (approximately 5 years)
DOR defined in those with Best Overall Response (BOR)=CR or PR per independent review committee (IRC) as time between date of response of confirmed CR or PR, whichever occurred first, and date of PD or death. If PR assessed before CR, DOR confirmed at earlier time-point showing PR. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions;no evidence of PD; PR=50% or greater decrease in the sum of products of longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline. PD=an increase of 25% or greater in SPD of index lesions compared with the smallest recorded sum, or appearance of 1 or more new lesions. Immune-related response criteria (irRC): SD=50% decrease in total measurable tumor burden compared with peak cannot be established nor 25% increase compared with nadir, in absence of unequivocal progression of nonindex lesions. Unconfirmed immune-related (ir) CR, irPR, or irPD=irSD.
Day of CR or PR to day of PD or death up to data cutoff for primary endpoint (approximately 5 years)
Time to Response: All Randomized Participants With Response to Treatment
大体时间：First dose to date of BOR up to data cutoff for primary endpoint (approximately 5 years)
Time to response was defined as the time between the first dose of study therapy and the date when measurement criteria were met for Best Overall Response (BOR) of partial response (PR) or complete response (CR), whichever occurred first, per independent review committee. Note that if an overall response of PR occurred before confirmation of CR, the time to response endpoint was not determined by the time that the BOR of CR was shown but rather by the earlier time point showing PR. Modified criteria of the World Health Organization: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline; PD=an increase of 25% or greater in the SPD of index lesions compared with the smallest recorded sum, or the appearance of 1 or more new lesions.
First dose to date of BOR up to data cutoff for primary endpoint (approximately 5 years)
Duration of Stable Disease (SD): Randomized Participants With Stable Disease
大体时间：Week 12 to date of disease progression or death up to data cutoff for primary endpoint (approximately 5 years)
Duration of SD was defined in those whose Best Overall Response (BOR) was SD, per independent review committee (IRC) as the time between Week 12 and date of progressive disease (PD) or death , whichever occurs first. For those who underwent tumor resection following Week 12 but prior to PD, duration of SD was censored on date of last evaluable tumor assessment (TA) prior to resection. For those with BOR of SD at Week 12, date of PD was used in analysis of duration of SD. For those with BOR=SD who have not subsequently progressed and who remain alive, duration of SD censored on date of last evaluable TA. Modified criteria of the World Health Organization (mWHO): SD=insufficient decrease to qualify for partial response or sufficient increase to qualify for PD; PD=an increase of 25% or more in sum of products of longest diameter and greatest perpendicular diameter of index lesions compared with smallest recorded sum, or appearance of 1 or more new lesions.
Week 12 to date of disease progression or death up to data cutoff for primary endpoint (approximately 5 years)
Percentage of Participants With Brain Metastasis-Free Survival at Time of Data Cutoff
大体时间：Date of randomization up to data cutoff for primary endpoint (approximately 5 years)
Brain metastasis-free survival was defined as the time from randomization to the date of progression with a new lesion located in the brain. New brain lesions prior to Week 12 constituted a progression event (unlike main progression-free survival analysis). A participant who dies without documentation of a brain lesion was considered to have progressed with brain metastasis on the date of death. Participants who are free of brain metastasis were censored on the date of their last tumor assessment. An independent review committee evaluated images of participants with clinical symptoms to determine the number of those free of brain metastasis. The brain metastasis-free status was reported as a percent of participants (n/N), where n= participants with metastasis-free brains at data cutoff for the Primary Endpoint and N= randomized participants. A 2-sided Clopper and Pearson confidence interval was performed.
Date of randomization up to data cutoff for primary endpoint (approximately 5 years)
Number of Participants With Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Hypersensitivity, Immune-related AEs/SAEs, and Inflammatory AEs/SAEs
大体时间：Week 1 (First Dose) to 70 days after last dose of study up to data cutoff for primary endpoint (approximately 5 years)
AE=any new undesirable symptom, sign, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be drug-related. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Randomization=Day 1; start of treatment (first dose)=Week 1. Summarization time frame is from first dose to 70 days after last dose of study at time of 414 deaths.
Week 1 (First Dose) to 70 days after last dose of study up to data cutoff for primary endpoint (approximately 5 years)
Number of Participants With Grade 2-3 and Grade 3-4 Immune-related Adverse Events (irAEs) With Resolution Resolved
大体时间：Week 1 (first dose) to 70 days after last dose up to data cutoff for primary endpoint (approximately 5 years)
irAEs included the categories: gastrointestinal (GI), diarrhea, liver, endocrine, and skin. Grade 2=moderate adverse events (AEs); minimal, local, or noninvasive intervention indicated. Grade 3=severe AEs, medically significant but not immediately life-threatening. Grade 4=life-threatening consequences; urgent intervention indicated. Resolution is defined as improvement to Grade 1 or less or to the Grade at baseline (prior to treatment).
Week 1 (first dose) to 70 days after last dose up to data cutoff for primary endpoint (approximately 5 years)
Time to Resolution of Grade 2-3, Grade 3-4 Immune-related Adverse Events (irAEs)
大体时间：Week 1 (first dose) to 70 days after last dose up to database lock for primary endpoint (approximately 5 years)
irAEs included the categories: gastrointestinal (GI), diarrhea, liver, endocrine, and skin. Grade 2=Moderate adverse events (AEs); minimal, local or noninvasive intervention indicated. Grade 3=severe AEs, medically significant but not immediately life-threatening. Grade 4=life-threatening consequences; urgent intervention indicated. Time to resolution is defined as improvement to Grade 1 or less or to the Grade at baseline (prior to treatment).
Week 1 (first dose) to 70 days after last dose up to database lock for primary endpoint (approximately 5 years)

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

Medarex

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

2006年8月1日

初级完成 (实际的)

2011年1月1日

研究完成 (实际的)

2013年10月1日

研究注册日期

首次提交

2006年5月8日

首先提交符合 QC 标准的

2006年5月9日

首次发布 (估计)

2006年5月10日

研究记录更新

最后更新发布 (估计)

2014年11月2日

上次提交的符合 QC 标准的更新

2014年10月24日

最后验证

2014年10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

  • CA184-024

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