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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

調査の概要

状態

完了

条件

介入・治療

詳細な説明

For the extension phase:

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

研究の種類

介入

入学 (実際)

681

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アイルランド
      • Cork、アイルランド
        • Local Institution
      • Galway、アイルランド
        • Local Institution
    • Dublin 4
      • Dublin、Dublin 4、アイルランド
        • Local Institution
  • アメリカ
    • California
      • Anaheim、California、アメリカ、92801
        • Pacific Cancer Medical Center
      • La Verne、California、アメリカ、91750
        • Wilshire Oncology Medical Group Inc
      • Los Angeles、California、アメリカ、90025
        • The Angeles Clinic and Research Institute
      • Palm Springs、California、アメリカ、92262
        • Comprehensive Cancer Center
      • San Diego、California、アメリカ、92123
        • Sharp Clinical Oncology Research
    • Connecticut
      • Hartford、Connecticut、アメリカ、06105
        • Saint Francis Hospital and Medical Center
      • Stamford、Connecticut、アメリカ、06902-3628
        • Hematology Oncology, P.C.
    • Florida
      • Jacksonville、Florida、アメリカ、32256
        • Cancer Specialists Of North Florida Beaches
      • Orlando、Florida、アメリカ、32806
        • Orlando Health, Inc. M.D. Anderson Cancer Center Orlando
      • Port Saint Lucie、Florida、アメリカ、34952
        • Hematology Oncology Associates of the Treasure Coast
    • Illinois
      • Chicago、Illinois、アメリカ、60637
        • University of Chicago
      • Normal、Illinois、アメリカ、61761
        • Mid-Illinois Hematology/Oncology Associates, Ltd.
      • Park Ridge、Illinois、アメリカ、60068
        • Oncology Specialists, SC
    • Indiana
      • Fishers、Indiana、アメリカ、46037
        • Central Indiana Cancer Centers
      • Indianapolis、Indiana、アメリカ、46202
        • Indiana University Cancer Center
    • Kansas
      • Hutchinson、Kansas、アメリカ、67502
        • Hutchinson Clinic, Pa
    • Kentucky
      • Hazard、Kentucky、アメリカ、41701
        • Kentucky Cancer Clinic
    • Maryland
      • Baltimore、Maryland、アメリカ、21215
        • Sinai Hospital of Baltimore
      • Baltimore、Maryland、アメリカ、21204
        • Greater Baltimore Medical Center
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02115
        • Dana Farber Cancer Institute
    • Missouri
      • Columbia、Missouri、アメリカ、65203
        • Ellis Fischel Cancer Center
      • Saint Joseph、Missouri、アメリカ、64507
        • St Joseph Oncology Inc
    • New Mexico
      • Albuquerque、New Mexico、アメリカ、87106
        • University of New Mexico Cancer Center
    • New York
      • New York、New York、アメリカ、10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Charlotte、North Carolina、アメリカ、28204
        • Blumenthal Cancer Center
    • Oregon
      • Portland、Oregon、アメリカ、97213
        • Providence Portland Medical Center
    • Pennsylvania
      • Bethlehem、Pennsylvania、アメリカ、18015
        • St. Luke's Hospital & Health Network
    • South Carolina
      • Mount Pleasant、South Carolina、アメリカ、29464
        • Lowcountry Hematology & Oncology, Pa
    • Tennessee
      • Knoxville、Tennessee、アメリカ、37916
        • Thompson Cancer Survival Center
      • Nashville、Tennessee、アメリカ、37232
        • Vanderbilt-Ingram Cancer Ctr
    • Texas
      • Lubbock、Texas、アメリカ、79410
        • Joe Arrington Cancer Research and Treatment Center
    • Virginia
      • Richmond、Virginia、アメリカ、23226
        • Virginia Cancer Institute
  • アルゼンチン
      • Buenos Aires、アルゼンチン、C1426ANZ
        • Local Institution
      • Buenos Aires、アルゼンチン、C1408INH
        • Local Institution
      • Buenos Aires、アルゼンチン、1185
        • Local Institution
      • Cordoba、アルゼンチン、X5000AAI
        • Local Institution
      • Santa Fe、アルゼンチン、S3000FFU
        • Local Institution
  • イギリス
    • Avon
      • Bristol、Avon、イギリス、BS2 8ED
        • Local Institution
    • Dorset
      • Poole、Dorset、イギリス、BH15 2JB
        • Local Institution
    • Essex
      • Chelmsford、Essex、イギリス、CM1 7ET
        • Local Institution
    • Greater London
      • London、Greater London、イギリス、SW3 6JJ
        • Local Institution
    • Merseyside
      • Wirral、Merseyside、イギリス、CH63 3JY
        • Local Institution
    • Surrey
      • Guildford、Surrey、イギリス、GU2 7XX
        • Local Institution
  • イスラエル
      • Jerusalem、イスラエル、91120
        • Local Institution
      • Tel Aviv、イスラエル、64239
        • Local Institution
  • イタリア
      • Genova、イタリア、16128
        • Local Institution
      • Milano、イタリア、20141
        • Local Institution
      • Napoli、イタリア、80131
        • Local Institution
      • Padova、イタリア、35128
        • Local Institution
      • Ragusa、イタリア、97100
        • Local Institution
      • Rome、イタリア、00144
        • Local Institution
      • Siena、イタリア、53100
        • Local Institution
  • ウクライナ
      • Cherkassy、ウクライナ、18009
        • Local Institution
      • Dnepropetrovsk、ウクライナ、49044
        • Local Institution
      • Lviv、ウクライナ、79031
        • Local Institution
      • Uzhgorod、ウクライナ、88000
        • Local Institution
  • オランダ
      • Eindhoven、オランダ、5623 EJ
        • Local Institution
      • Hv Amsterdam、オランダ、1081
        • Local Institution
      • Wurzburg、オランダ、97080
        • Local Institution
  • オーストラリア
    • New South Wales
      • Coffs Harbour、New South Wales、オーストラリア、2450
        • Local Institution
      • Newcastle、New South Wales、オーストラリア、2300
        • Local Institution
      • Port Macquarie、New South Wales、オーストラリア、2444
        • Local Institution
    • Queensland
      • South Brisbane、Queensland、オーストラリア、4101
        • Local Institution
    • Victoria
      • Box Hill、Victoria、オーストラリア、3128
        • Local Institution
  • オーストリア
      • Vienna、オーストリア、1090
        • Local Institution
  • カナダ
    • Alberta
      • Edmonton、Alberta、カナダ、T6G 1Z2
        • Local Institution
    • Quebec
      • Montreal、Quebec、カナダ、H3T 1E2
        • Local Institution
      • Montreal、Quebec、カナダ、H1T 2W4
        • Local Institution
    • Saskatchewan
      • Saskatoon、Saskatchewan、カナダ、S7N 4H4
        • Local Institution
  • スイス
      • Basel、スイス、CH-4031
        • Local Institution
      • Geneva、スイス、1211
        • Local Institution
  • スペイン
      • Barcelona、スペイン、08036
        • Local Institution
      • Canarias、スペイン、38320
        • Local Institution
      • Valencia、スペイン、46014
        • Local Institution
      • Zaragoza、スペイン、50009
        • Local Institution
  • チェコ共和国
      • Olomouc、チェコ共和国、775 20
        • Local Institution
      • Praha、チェコ共和国、128 08
        • Local Institution
  • チリ
      • Santiago、チリ
        • Local Institution
  • ドイツ
      • Berlin、ドイツ、12200
        • Local Institution
      • Heidelberg、ドイツ、69120
        • Local Institution
      • Jena、ドイツ、07740
        • Local Institution
      • Kiel、ドイツ、24105
        • Local Institution
      • Mannheim、ドイツ、68167
        • Local Institution
      • Muenchen、ドイツ、81675
        • Local Institution
      • Tubingen、ドイツ、72076
        • Local Institution
  • ノルウェー
    • Oslo
      • Montebello、Oslo、ノルウェー、0310
        • Local Institution
  • ハンガリー
      • Kaposyar、ハンガリー、7400
        • Local Institution
  • フランス
      • Bordeaux、フランス、33075
        • Local Institution
      • Marseille、フランス、13009
        • Local Institution
      • Paris、フランス、75010
        • Local Institution
      • Pierre Benite、フランス、69495
        • Local Institution
      • Villejuif、フランス、94805
        • Local Institution
    • Cedex
      • Brest、Cedex、フランス、29200
        • Local Institution
    • Cedex 1
      • Nantes、Cedex 1、フランス、44093
        • Local Institution
    • Cedex 2
      • Saint Etienne、Cedex 2、フランス、42055
        • Local Institution
  • ブラジル
      • Sao Paulo、ブラジル、01508-010
        • Local Institution
    • Ceara
      • Fortaleza、Ceara、ブラジル、60430-230
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre、Rio Grande Do Sul、ブラジル、90050-170
        • Local Institution
      • Porto Alegre, Rs、Rio Grande Do Sul、ブラジル、90610-000
        • Local Institution
  • ベルギー
      • Brasschaat、ベルギー、2930
        • Local Institution
      • Brussels、ベルギー、1200
        • Local Institution
      • Edegem、ベルギー、B-2650
        • Local Institution
      • Gent、ベルギー、9000
        • Local Institution
  • ポルトガル
      • Lisboa、ポルトガル、1099-023
        • Local Institution
  • ポーランド
      • Gdansk、ポーランド、80-219
        • Local Institution
      • Lodz、ポーランド、93-509
        • Local Institution
      • Lublin、ポーランド、20-090
        • Local Institution
      • Poznan、ポーランド、61-866
        • Local Institution
      • Wroclaw、ポーランド、51-124
        • Local Institution
  • ロシア連邦
      • Moscow、ロシア連邦、115478
        • Local Institution
      • Moscow、ロシア連邦、105229
        • Local Institution
      • Murmansk、ロシア連邦、183047
        • Local Institution
      • Ryazan、ロシア連邦、390011
        • Local Institution
      • Samara、ロシア連邦、443066
        • Local Institution
      • St Petersburg、ロシア連邦、198255
        • Local Institution
      • St.-Petersburg、ロシア連邦、191104
        • Local Institution
      • Stavropol、ロシア連邦、355047
        • Local Institution
    • Stavropol
      • Pyatigorsk、Stavropol、ロシア連邦、357502
        • Local Institution
  • 南アフリカ
      • Johannesburg、南アフリカ、2199
        • Local Institution
    • Eastern Cape
      • Port Elizabeth、Eastern Cape、南アフリカ、6000
        • Local Institution
    • Gauteng
      • Groenkloof、Gauteng、南アフリカ、0181
        • Local Institution
      • Pretoria、Gauteng、南アフリカ、0041
        • Local Institution
      • Saxonworld、Gauteng、南アフリカ、2196
        • Local Institution
    • Western Cape
      • Cape Town、Western Cape、南アフリカ、7570
        • Local Institution

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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
薬：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

他の名前：
  • BMS-734016
  • MDX-010
薬：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
アクティブコンパレータ：Arm B: Placebo and Dacarbazine
薬：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
薬：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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival (OS)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Bristol-Myers Squibb

協力者

Medarex

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2006年8月1日

一次修了 (実際)

2011年1月1日

研究の完了 (実際)

2013年10月1日

試験登録日

最初に提出

2006年5月8日

QC基準を満たした最初の提出物

2006年5月9日

最初の投稿 (見積もり)

2006年5月10日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年11月2日

QC基準を満たした最後の更新が送信されました

2014年10月24日

最終確認日

2014年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CA184-024

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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