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A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies

28 de junio de 2016 actualizado por: Bristol-Myers Squibb

A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.

The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

248

Fase

  • Fase 2

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, D-12200
        • Local Institution
      • Heidelberg, Alemania, 69120
        • Local Institution
      • Kiel, Alemania, D-24105
        • Local Institution
  • Argentina
      • Buenos Aires, Argentina, CP1280AEB
        • Local Institution
  • Austria
      • Wels, Austria, A-4600
        • Local Institution
      • Wien, Austria, 1090
        • Local Institution
  • Brasil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brasil, 90610
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brasil, 90050
        • Local Institution
    • Sao Paulo
      • Jau, Sao Paulo, Brasil, 17210
        • Local Institution
  • Bélgica
      • Brussels, Bélgica, 1090
        • Local Institution
      • Brussels, Bélgica, 1070
        • Local Institution
      • Bruxelles, Bélgica, 1200
        • Local Institution
  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 4N2
        • Local Institution
      • Edmonton, Alberta, Canadá, T6G 1Z2
        • Local Institution
    • New Brunswick
      • Moncton, New Brunswick, Canadá, E1C 6Z8
        • Local Institution
  • Dinamarca
      • Aarhus C, Dinamarca, 8000
        • Local Institution
  • España
      • Malaga, España, 29010
        • Local Institution
      • Valencia, España, 46009
        • Local Institution
  • Estados Unidos
    • Arizona
      • Tucson, Arizona, Estados Unidos, 85719
        • University of Arizona Cancer Center
    • California
      • Laverne, California, Estados Unidos, 91750
        • Wilshire Oncology Medical Group Inc
      • Los Angeles, California, Estados Unidos, 90033
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, Estados Unidos, 90025
        • The Angeles Clinic & Research Inst.
      • San Francisco, California, Estados Unidos, 94115
        • San Francisco Oncology Associates
    • Connecticut
      • To come, Connecticut, Estados Unidos
        • Local Institution
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32207
        • Baptist Cancer Institute
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Indiana Oncology Hematology Consultants
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine
      • St Joseph, Missouri, Estados Unidos, 64507
        • St Joseph Oncology Inc
    • New York
      • New York, New York, Estados Unidos, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28203
        • Carolinas Medical Center
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45219
        • The Christ Hospital Cancer Center Research
    • Oregon
      • Portland, Oregon, Estados Unidos, 97213
        • Providence Portland Medical Center
    • South Carolina
      • Greenville, South Carolina, Estados Unidos, 29615
        • Cancer Centers of the Carolinas
    • Texas
      • Dallas, Texas, Estados Unidos, 75230
        • Center For Oncology Research & Treatment, P.A.
      • Lubbock, Texas, Estados Unidos, 79410
        • Joe Arrington Cancer Research and Treatment Center
    • Washington
      • Seattle, Washington, Estados Unidos, 98109
        • University of Washington Medical Center
  • Federación Rusa
      • St. Petersburg, Federación Rusa, 191104
        • Local Institution
      • Stavropol, Federación Rusa, 355047
        • Local Institution
      • Voronezh, Federación Rusa, 394000
        • Local Institution
  • Francia
      • Brest, Francia, 29200
        • Local Institution
      • Lyon Cedex 08, Francia, 69373
        • Local Institution
      • Paris, Francia, 75010
        • Local Institution
      • Vandoeuvre Les Nancy, Francia, 54511
        • Local Institution
  • Israel
      • Jerusalem, Israel, 91120
        • Local Institution
      • Tel-Aviv, Israel, 64239
        • Local Institution
  • Italia
      • Genova, Italia, 16132
        • Local Institution
      • Meldola (Fc), Italia, 47014
        • Local Institution
      • Rimini, Italia, 47900
        • Local Institution
      • Siena, Italia, 53100
        • Local Institution
  • Noruega
      • Oslo, Noruega, 0310
        • Local Institution
  • Polonia
      • Lodz, Polonia, 90553
        • Local Institution
      • Poznan, Polonia, 61-866
        • Local Institution
      • Wroclaw, Polonia, 51-124
        • Local Institution
  • República Checa
      • Olomouc, República Checa, 775 20
        • Local Institution
  • Sudáfrica
    • Gauteng
      • Johannesburg, Gauteng, Sudáfrica, 2199
        • Local Institution
    • Western Cape
      • Cape Town, Western Cape, Sudáfrica, 7570
        • Local Institution
  • Ucrania
      • Dnepropetrovsk, Ucrania, 49044
        • 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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria

  • Diagnosis of advanced melanoma
  • Prior treatment in a prespecified prior/parent ipilimumab study
  • Men and women 18 years of age and older

First Reinduction:

  • No unacceptable toxicity (except select reversible immune-related adverse events) requiring ipilimumab discontinuation
  • Had experienced documented progressive disease after expanded clinical benefit

Extended Maintenance

  • Received ipilimumab at any dose in a parent study
  • Achieved expanded clinical benefit at the time of entry to current study

Follow-up:

  • Received ipilimumab at any dose in a closing parent study
  • Deemed ineligible for reinduction or extended maintenance treatment or refused treatment as reinduction or extended maintenance at the time of screening in the current study, but consented to follow-up

Key Exclusion Criteria

  • Prior treatment with a CD137 agonist or a cytotoxic T-lymphocyte antigen 4 inhibitor or agonist, other than ipilimumab
  • 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: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: First reinduction: Ipilimumab, 0.3 to 10 mg/kg
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Droga: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Otros nombres:
  • BMS-734016
  • MDX-010
Experimental: First reinduction: Ipilimumab, 3 to 10 mg/kg
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Droga: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Otros nombres:
  • BMS-734016
  • MDX-010
Experimental: First reinduction: Ipilimumab, 10 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Droga: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Otros nombres:
  • BMS-734016
  • MDX-010
Experimental: Extended maintenance: Ipilimumab, 0.3 mg/kg
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Droga: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Otros nombres:
  • BMS-734016
  • MDX-010
Experimental: Extended maintenance: Ipilimumab, 3 mg/kg
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Droga: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Otros nombres:
  • BMS-734016
  • MDX-010
Experimental: Extended maintenance: Ipilimumab, 10 mg
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Droga: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Otros nombres:
  • BMS-734016
  • MDX-010
Sin intervención: Follow-up
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
Periodo de tiempo: Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is 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. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS)
Periodo de tiempo: From first dose of study drug in parent study to death or date of last censoring.
OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.
From first dose of study drug in parent study to death or date of last censoring.
Percentage of Participants Surviving at 1, 1.5, and 2 Years
Periodo de tiempo: From first dose of study drug in parent study to up to 2 years after reinduction
Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.
From first dose of study drug in parent study to up to 2 years after reinduction
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Periodo de tiempo: From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date
irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.
From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date
Progression-free Survival (PFS)
Periodo de tiempo: From day of first reinduction in current study to date of progression or death, whichever occurred first.
PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.
From day of first reinduction in current study to date of progression or death, whichever occurred first.

Colaboradores e Investigadores

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

Patrocinador

Bristol-Myers Squibb

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 mayo de 2006

Finalización primaria (Actual)

1 de septiembre de 2012

Finalización del estudio (Actual)

1 de abril de 2014

Fechas de registro del estudio

Enviado por primera vez

9 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2005

Publicado por primera vez (Estimar)

13 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

27 de julio de 2016

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

28 de junio de 2016

Última verificación

1 de junio de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CA184-025

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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