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

24 de octubre de 2014 actualizado por: 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

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

For the extension phase:

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

Tipo de estudio

Intervencionista

Inscripción (Actual)

681

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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
Droga: 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

Otros nombres:
  • BMS-734016
  • MDX-010
Droga: 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
Comparador activo: Arm B: Placebo and Dacarbazine
Droga: 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
Droga: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Bristol-Myers Squibb

Colaboradores

Medarex

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2006

Finalización primaria (Actual)

1 de enero de 2011

Finalización del estudio (Actual)

1 de octubre de 2013

Fechas de registro del estudio

Enviado por primera vez

8 de mayo de 2006

Primero enviado que cumplió con los criterios de control de calidad

9 de mayo de 2006

Publicado por primera vez (Estimar)

10 de mayo de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

2 de noviembre de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

24 de octubre de 2014

Última verificación

1 de octubre de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CA184-024

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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