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

24 октября 2014 г. обновлено: 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

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

For the extension phase:

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

Тип исследования

Интервенционный

Регистрация (Действительный)

681

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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
Лекарство: 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

Другие имена:
  • БМС-734016
  • МДС-010
Лекарство: 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
Активный компаратор: Arm B: Placebo and Dacarbazine
Лекарство: 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
Лекарство: 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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Overall Survival (OS)
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)

Соавторы и исследователи

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Спонсор

Bristol-Myers Squibb

Соавторы

Medarex

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 августа 2006 г.

Первичное завершение (Действительный)

1 января 2011 г.

Завершение исследования (Действительный)

1 октября 2013 г.

Даты регистрации исследования

Первый отправленный

8 мая 2006 г.

Впервые представлено, что соответствует критериям контроля качества

9 мая 2006 г.

Первый опубликованный (Оценивать)

10 мая 2006 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

2 ноября 2014 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

24 октября 2014 г.

Последняя проверка

1 октября 2014 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • CA184-024

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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