El propósito de este estudio es comparar la tasa de respuesta objetiva, la supervivencia libre de progresión y la supervivencia global de Nivolumab combinado con Ipilimumab frente a la monoterapia con Sunitinib en pacientes con cáncer de células renales no tratado previamente.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component
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:
One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
Karnofsky Performance Status (KPS) of at least 70%
Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Tumor tissue \[formalin-fixed paraffin-embedded (FFPE) archival or recent acquisition\] must be received by the central vendor (block or unstained slides) in order to randomize a subject to study treatment. (Note: Fine Needle Aspiration \[FNA\] and bone metastases samples are not acceptable for submission)

Criterios de exclusión

Any history of or current central nervous system (CNS) metastases. Baseline imaging of the brain is required within 28 days prior to randomization
Prior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but not limited to, Sunitinib, Pazopanib, Axitinib, Tivozanib, and Bevacizumab)
Prior treatment with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\>10 mg daily Prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll
Any condition requiring systemic treatment with corticosteroids (\>10 mg daily Prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses \>10 mg daily Prednisone equivalents are permitted in the absence of active autoimmune disease

Ubicaciones

Local Institution - 0099

Berazategui, Buenos Aires, Argentina

Local Institution - 0098

Capital Federal, Buenos Aires, Argentina

Local Institution - 0139

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Local Institution - 0095

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0096

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0097

CABA, Argentina

Local Institution - 0100

Córdoba, Argentina

Estudio de Fase 3, Aleatorizado, Abierto, de Nivolumab Combinado con Ipilimumab Versus Monoterapia con Sunitinib en Sujetos con Carcinoma de Células Renales Avanzado o Metastásico No Tratado Previamente

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Nivolumab

Ipilimumab

Sunitinib