A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT03873402Tipo: INTERVENTIONALInicio: 21 de jun de 2019Fin estimado: 11 de mar de 2027

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.

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 renal carcinoma with clear cell component including participants who may have sarcomatoid features.
Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC).
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.
No prior systemic therapy for RCC
Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC).

Criterios de exclusión

Any active central nervous system (CNS) metastases.
Active, known, or suspected autoimmune disease.
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways

Intervenciones

biological

Nivolumab

Specified dose on specified days

biological

Ipilimumab

Specified dose on specified days

other

Ipilimumab placebo

Specified dose on specified days

Ubicaciones

Local Institution - 0100

Capital Federal, Buenos Aires, Argentina

Local Institution - 0011

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0060

Mar del Plata, Buenos Aires, Argentina

Local Institution - 0025

Río Cuarto, Córdoba Province, Argentina

Local Institution - 0001

Viedma, Río Negro Province, Argentina

Local Institution - 0005

Córdoba, Argentina

Local Institution - 0002

San Juan, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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