Institut de Cancérologie Strasbourg Europe, 17 Rue Albert Calmette, Strasbourg, 67200, France.
Ipsen, 65 Quai Georges Gorse, Boulogne-Billancourt, 92100, France.
Future Oncol. 2024 Apr;20(13):811-819. doi: 10.2217/fon-2023-0353. Epub 2023 Jul 5.
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.
卡博替尼联合纳武利尤单抗获批用于晚期肾细胞癌（aRCC）的一线治疗，依据是 CheckMate 9ER 试验。CaboCombo（ClinicalTrials.gov 标识符：NCT05361434）是一项非干预性研究，旨在评估卡博替尼联合纳武利尤单抗在真实环境中的有效性和耐受性。该研究将在全球 7 个国家至少 70 个中心招募 311 例接受 1L 卡博替尼联合纳武利尤单抗治疗的透明细胞 aRCC 患者。主要终点为 18 个月时的总生存期。次要终点包括无进展生存期、客观缓解率、安全性、治疗模式、后续抗癌治疗和生活质量。CaboCombo 将提供关于接受 1L 卡博替尼联合纳武利尤单抗治疗的 aRCC 患者特征、治疗顺序和结局的真实世界证据。
