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

2014. október 24. frissítette: 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

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Részletes leírás

For the extension phase:

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

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

681

Fázis

  • 3. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Kettős

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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
Drog: 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

Más nevek:
  • BMS-734016
  • MDX-010
Drog: 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
Aktív összehasonlító: Arm B: Placebo and Dacarbazine
Drog: 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
Drog: 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

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Overall Survival (OS)
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Bristol-Myers Squibb

Együttműködők

Medarex

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Hasznos linkek

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2006. augusztus 1.

Elsődleges befejezés (Tényleges)

2011. január 1.

A tanulmány befejezése (Tényleges)

2013. október 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2006. május 8.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2006. május 9.

Első közzététel (Becslés)

2006. május 10.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Becslés)

2014. november 2.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2014. október 24.

Utolsó ellenőrzés

2014. október 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • CA184-024

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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