Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-Risk Renal Cell Carcinoma

The purpose of this study is to compare the usual treatment alone to using tivozanib plus the usual treatment for the treatment of patients with high-risk renal cell carcinoma (RCC). The study doctors will be looking to see if the addition of tivozanib for 6 months to pembrolizumab prevents kidney cancer from returning and improves life expectancy compared to pembrolizumab alone after surgery and/or radiation or ablation to remove all signs of kidney cancer.

• Adults 18+ years of age
• Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor
• Surgery (radical or partial nephrectomy or metastasectomy or ablation) prior to study registration with no ongoing complications from surgery
• No evidence of disease at time of randomization
• No prior systemic treatment for RCC

• Random assignment to receive either pembrolizumab alone given intravenously (IV) or pembrolizumab (IV) plus tivozanib, given by mouth daily
• Imaging with magnetic resonance imaging (MRI) scans or computed tomography (CT) scans
• Blood sample collection
• A tissue biopsy, if needed
• Completing questionnaires about your quality of life and fatigue