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Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma - CA209-76K

Actualizada: 20 September, 2019   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 3

    Fase

  • Géneros

  • 12+

    Rango de edad

  • 77

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Nivolumab
Biological: Nivolumab
Placebo Comparator: Placebo
Other: Placebo

Criterios clave de elegibilidad

Inclusion Criteria: - Had a negative sentinel lymph node biopsy - Participant has not been previously treated for melanoma - ECOG 0 or 1 - Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways Exclusion Criteria: - History of ocular or mucosal melanoma. - Pregnant or nursing women - Participants with active known or suspected autoimmune disease - Known history of allergy or hypersensitivity to study drug components. 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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