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A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma - CA209-73M

Actualizada: 02 October, 2019   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 2

    Fase

  • Géneros

  • 18+

    Rango de edad

  • 12

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Nivolumab + Ipilimumab (combination)
Biological: Ipilimumab Biological: Nivolumab

Criterios clave de elegibilidad

Inclusion Criteria: -Participants and Target Disease Characteristics- - - Confirmed disease progression by RECIST 1.1 criteria on nivolumab maintenance after induction with ipilimumab and nivolumab - Progress of maintenance treatment of nivolumab by RECIST. Pathology report must be submitted for embedded tissue block or tumor tissue. Age and Reproduction Sexually active males with WOCBP must agree to instructions for contraception and fetal protection. WOCBP need to use contraception throughout the study and for 5 months post treatment. Exclusion Criteria autoimmune disease statement - Active central nervous system metastases - Participants with an active autoimmune disease, diabetes mellitus, skin disorders, hyperthyroidism requiring hormone treatments are permitted to enroll. - Any major surgery 28 days before 1st treatment Concomitant Therapy - participants that have received a live vaccine within 30 days of treatment. - use of investigational agent or device with in 28 days before first dosage study treatment. Physical and Laboratory Test Findings Allergies and Adverse Drug Reaction Age and Reproduction

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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