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

24. Oktober 2014 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

For the extension phase:

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

Studientyp

Interventionell

Einschreibung (Tatsächlich)

681

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Arzneimittel: 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

Andere Namen:
  • BMS-734016
  • MDX-010
Arzneimittel: 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
Aktiver Komparator: Arm B: Placebo and Dacarbazine
Arzneimittel: 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
Arzneimittel: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival (OS)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Bristol-Myers Squibb

Mitarbeiter

Medarex

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. August 2006

Primärer Abschluss (Tatsächlich)

1. Januar 2011

Studienabschluss (Tatsächlich)

1. Oktober 2013

Studienanmeldedaten

Zuerst eingereicht

8. Mai 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Mai 2006

Zuerst gepostet (Schätzen)

10. Mai 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

2. November 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Oktober 2014

Zuletzt verifiziert

1. Oktober 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CA184-024

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