A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT03141177Tipo: INTERVENTIONALInicio: 23 de jul de 2017Fin estimado: 16 de ene de 2026

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
No prior systemic therapy for RCC with the following exception:
i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

Criterios de exclusión

Any active CNS metastases
Any active, known or suspected autoimmune disease
Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
Participants who have received a live/attenuated vaccine within 30 days of first treatment

Intervenciones

biological

Nivolumab

Specified dose on specified day

drug

Cabozantinib

Specified dose on specified days

drug

Sunitinib

Specified dose on specified days.

biological

Ipilimumab

Specified dose on specified days

Ubicaciones

Local Institution - 0046

CABA, Buenos Aires, Argentina

Local Institution - 0048

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Local Institution - 0114

Viedma, Río Negro Province, Argentina

Local Institution - 0138

CABA, Argentina

Local Institution - 0050

Córdoba, Argentina

Local Institution - 0049

Córdoba, Argentina

Local Institution - 0047

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorExelixis

ColaboradorOno Pharmaceutical Co. Ltd

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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