Table 4.
Clinical studies in renal cell carcinoma.
| Patient group | Treatment | Participants (n) | Trial, ID | Outcomes | Reference |
|---|---|---|---|---|---|
| Metastatic RCC | Nivolumab + ipilimumab | 94 (NIVO3+IPI11=47, NIVO1+IPI32=47) |
Phase 1, (CheckMate 016) |
ORR: 40.4% | 40.4% 2-year OS: 67.3% | 69.6% Grade 3–4 AE: 38.3% | 61.7% |
Hammers et al., 2017 (81) |
| Advanced RCC | Nivolumab + ipilimumab | 550 | Phase 3, NCT02231749 (CheckMate 214) |
ORR: 42% 12-month OS rate: 80% 18-month OS rate: 75% Median OS: Not reached Median PFS: 11.6 months Any grade AEs: 93% Grade 3–4 AEs: 46% |
Motzer et al., 2018 (82) |
| Advanced RCC | Nivolumab + ipilimumab | 30 | Phase 2, NCT02996110 (FRACTION-RCC) |
ORR: 20% Median OS: 38.2 months 1-year OS rate: 84% Median PFS: 3.4 months 24-week PFS rate: 49% |
Choueiri et al., 2024 (83) |
| Advanced non-clear-cell RCC | Nivolumab + ipilimumab | 52 | Phase 3b/4, NCT02982954 (CheckMate 920) |
ORR: 19.6% Median PFS: 3.7 months Median OS: 21.2 months Grade 3–4 AE: 23% |
Tykodi et al., 2022 (84) |
| Metastatic non-clear-cell RCC | Nivolumab + ipilimumab | 18 | — |
ORR: 33.3% Median PFS: 7.1 months 6-months PFS: 60.6% 12-months PFS: 46.8% 12-months OS: 64.2% Grade 3–4 AE: 38% |
Gupta et al., 2020 (85) |
| Advanced non-clear- cell RCC | Nivolumab + ipilimumab | 41 | Phase 2, NCT03177239 (UNISoN) |
ORR: 10% Median DOR: 13.5 months Median PFS: 2.6 months Grade ≥3 AE: 49% |
Conduit et al., 2024 (86) |
1Nivolumab 3 mg/kg plus ipilimumab 1 mg/kg.
2Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg.
AE, adverse event; DOR, duration of response; ORR, objective response rate; OS, overall survival; PFS, progression-free survival.