Background: Strategy to kidney cell carcinoma continues to be revolutionised by inhibitors of VEGF receptor. Previous research has recommended that treatment having a VEGF receptor (VEGFR) tyrosine kinase inhibitor may be good at patients who’d previous checkpoint inhibitor therapy. Therefore, TIVO-3 is built to compare the effectiveness and safety of tivozanib (a powerful and selective VEGFR inhibitor) with individuals of sorafenib as third-line or 4th-line therapy in patients with metastatic kidney cell carcinoma.

Methods: Within this open-label, randomised, controlled trial done at 120 academic hospitals in 12 countries, we enrolled qualified patients over the age of 18 years with histologically or cytologically confirmed metastatic kidney cell carcinoma and a minimum of two previous systemic treatments (including a minumum of one previous treatment having a VEGFR inhibitor), measurable disease based on the Response Evaluation Criteria in Solid Tumors version 1.1, as well as an Eastern Cooperative Oncology Group performance status of or 1. Patients were excluded when they had received previous treatment with tivozanib or sorafenib. Patients were stratified by Worldwide Metastatic Kidney Cell Carcinoma Database Consortium risk category and kind of previous therapy and randomised (1:1) having a complete permuted block design (block size four) either to tivozanib 1·5 mg orally once daily in 4-week cycles or sorafenib 400 mg orally two times daily continuously. Investigators and patients weren’t masked to treatment. The main endpoint was progression-free survival by independent review within the intention-to-treat population. Safety analyses were completed in all patients who received a minumum of one dose of study treatment. This trial is registered with ClinicalTrials.gov, NCT02627963.