CaboCombo: a prospective, phase IV study of first-line cabozantinib + nivolumab for advanced renal cell carcinoma.

Cabozantinib plus nivolumab was approved as a first-line (1L) treatment for advanced renal cell carcinoma (aRCC) following the CheckMate 9ER trial. CaboCombo (ClinicalTrials.gov identifier: NCT05361434) is a non-interventional study designed to evaluate the effectiveness and tolerability of cabozantinib plus nivolumab in a real-world setting. Overall, 311 patients with clear-cell aRCC receiving 1L cabozantinib plus nivolumab will be recruited from at least 70 centers in seven countries worldwide. The primary end point is overall survival at 18 months. Secondary end points include progression-free survival, objective response rate, safety, patterns of treatment, subsequent anticancer therapies and quality of life. CaboCombo will provide real-world evidence on the characteristics, treatment sequences, and outcomes of patients with aRCC receiving 1L cabozantinib plus nivolumab.