The multicentre, randomized, phase III trial TiNivo-2 was conducted to assess the efficacy of the vascular endothelial growth factor receptor inhibitor tivozanib alone versus in combination with the immune checkpoint inhibitor (ICI) nivolumab in patients with advanced renal cell carcinoma (RCC) who had progressed during or after 1–2 previous lines of therapy including one ICI. Progression-free survival (PFS) was higher in patients in the monotherapy group (7.4 months) than in patients receiving combination therapy (5.7 months; HR 1.10, 95% CI 0.84–1.43; P = 0.49). These results show that re-challenging patients with advanced RCC with ICI therapy is not advisable and suggest tivozanib monotherapy as a viable treatment option in the post-ICI setting.

进行多中心、随机、III 期试验 TiNivo-2 以评估血管内皮生长因子受体抑制剂 tivozanib 单独与免疫检查点抑制剂 （ICI） 纳武利尤单抗联合治疗对晚期肾细胞癌 （RCC） 患者的疗效，这些患者在 1-2 线治疗期间或之后出现进展，包括 1 次 ICI。单药治疗组患者的无进展生存期 （PFS） （7.4 个月） 高于接受联合治疗的患者 （5.7 个月;HR 1.10,95% CI 0.84–1.43;P = 0.49）。这些结果表明，不建议使用 ICI 治疗再次挑战晚期 RCC 患者，并建议将 tivozanib 单药治疗作为 ICI 后情况下的可行治疗选择。