Table 3.
Trials in second-line therapy.
| POST TKI | |||||
|---|---|---|---|---|---|
| Trial | Comparators | Primary endpoint | Secondary endpoints | Median OS | HR |
| Checkmate 025 (phase III) | Nivolumab (N = = 410) versus Everolimus (N = = 411) | OS | ORR, PFS, OS by PD-L1 expression, incidence of AEs | 25.8 versus 19.7 | 0.73 (95% CI 0.62–0.85) |
| METEOR (phase III) | Cabozantinib (N = = 330) versus Everolimus (N = = 328) | PFS | OS, ORR | 21.4 versus 17.1 | 0.70 (95% CI 0.58–0.85) |
| Keynote 581/CLEAR (study 307) (phase III) | Lenvatinib + Everolimus (N = = 357) or Lenvatinib + Pembrolizumab (N = = 355) versus Sunitinib (N = = 357) | PFS | OS, ORR, safety | NA | Lenvatinib + Everolimus versus Sunitinib 1.15 (95% CI 0.88–1.5); Lenvatinib + Pembrolizumab versus Sunitinib 0.66 (95% CI 0.49–0.88) |
| POST IO combinations | |||||
| McGregor et al. 19 | Retrospective study. | ||||
| Cabozantinib in patients with metastatic clear-cell renal cell carcinoma after immune checkpoint blockade 86 patients. median OS 13 months (OS rate at 12 months) 19 | |||||
| Breakpoint | Open-label phase II - prospective study | ||||
| Breakpoint Meet-uro 03 (phase II) |
Cabozantinib in patients with advanced or metastatic renal cell carcinoma pretreated with a line of treatment with immune-checkpoints (anti-PD1/PDL1) inhibitor 20 | ||||
| There are no phase III prospective trials or recommendations, only retrospective evidence and cohort studies21,22 | |||||
CR, complete response rate; HR, hazard ratio; ORR, overall response rate; OS, overall survival; PFS, progression-free survival.