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A Study of Nivolumab and Ipilimumab in Combination With Transarterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer - CA209-74W

Actualizada: 7 agosto, 2020   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 3

    Fase

  • Géneros

  • 18+

    Rango de edad

  • 100

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Nivolumab + Ipilimumab + TACE
Biological: ipilimumab Biological: nivolumab
Experimental: Nivolumab + Ipilimumab Placebo + TACE
Biological: nivolumab Biological: ipilimumab
Placebo Comparator: Nivolumab Placebo + Ipilimumab Placebo + TACE
Biological: nivolumab Biological: ipilimumab

Criterios clave de elegibilidad

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participant has intermediate-stage HCC (hepatocellular carcinoma) whose tumor characteristics exceed the BMU7 criteria and is eligible for TACE - Participant has histologic confirmation of HCC - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 - Men and Women must agree to follow methods of contraception - Participants are eligible to enroll if they have non-viral related HCC, or if they have HBV-HCC, or HCV-HCC Exclusion Criteria: - Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC - Prior liver transplant or participants who are on the waiting list for liver transplantation - Active, known, or suspected autoimmune disease - Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications - Any previous TACE or TAE (trans-arterial embolization without instillation of chemotherapy agent) procedure for HCC - Known or suspected allergy to nivolumab, ipilimumab, or study drug components given in association with this trial Other protocol defined inclusion/exclusion criteria could apply

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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¿Tiene alguna pregunta? El soporte en vivo está disponible 24/7 -
Llame 855-907-3286 o Envíenos un correo electrónico