A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

CompletadoFase 3ClinicalTrials.gov

ID: NCT01668784Tipo: INTERVENTIONALInicio: 9 de oct de 2012Fin estimado: 19 de jul de 2021

Traducción no disponible, mostrando original

Resumen

The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Men \& women ≥18 years of age
Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component
Advanced/metastatic RCC
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment
Karnofsky Performance Score ≥70%

Criterios de exclusión

Any Central Nervous System (CNS) metastases or history of CNS metastases
Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor
Any active known or suspected autoimmune disease
Uncontrolled adrenal insufficiency
Active chronic liver disease
Prior malignancy active within past 3 years, except for locally curable cancers

Intervenciones

biological

Nivolumab

drug

Everolimus

Ubicaciones

COIBA

Berazategui, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Centro Para La Atencion Integral Del Paciente Oncologico

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution

Buenos Aires, Argentina

Local Institution

Buenos Aires, Argentina

Instituto Oncologico De Cordoba

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorOno Pharmaceutical Co. Ltd

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