Nivolumab With or Without Bevacizumab or Ipilimumab Before Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed by Surgery

Autores
Categoría Estudio primario
Registro de estudiosclinicaltrials.gov
Año 2014
PRIMARY OBJECTIVES: I. Safety and tolerability of therapy with nivolumab or nivolumab + bevacizumab or nivolumab + ipilimumab in metastatic renal cell carcinoma (mRCC) in the context of presurgical or prebiopsy therapy. SECONDARY OBJECTIVES: I. To study immunological changes in tumor tissues and peripheral blood in response to nivolumab versus (vs.) nivolumab + bevacizumab vs nivolumab + ipilimumab in renal cell carcinoma (RCC) therapy. II. To assess the efficacy of presurgical nivolumab or nivolumab + bevacizumab or nivolumab + ipilimumab therapy in RCC by evaluating objective response rate, duration of response, and progression free survival, and overall survival. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM A: Patients receive nivolumab intravenously (IV) over 60 minutes on day 1 every 2 weeks for 6 weeks. Approximately 4 weeks later, patients undergo nephrectomy, metastasectomy or biopsy. ARM B: Patients receive nivolumab IV over 60 minutes and bevacizumab IV over 90 minutes on day 1 every 2 weeks for 6 weeks. Patients also undergo nephrectomy, metastasectomy or biopsy as in Arm A. ARM C: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on day 1 every 3 weeks for 6 weeks. Patients also undergo nephrectomy, metastasectomy or biopsy as in Arm A. Beginning 4-6 weeks after surgery, patients in all arms who have clinical response, stable disease, or even slight progression of disease to therapy preoperatively, receive maintenance nivolumab IV over 60 minutes on day 1. Cycles repeat every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and 86 days, every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.
Epistemonikos ID: 82a9e28863f5f1229d2afbf69d3be5e07696b334
First added on: Jul 10, 2018