Table 1 Clinical trials of ICIs, ADCs, and their combined application in RCC.
Categories | Clinical trials | Phases | Patients | Drugs | Targets | Clinical outcomes | References |
---|---|---|---|---|---|---|---|
ICIs | CheckMate 025 | 3 | 821 aRCC | Nivo | PD-1 | Nivo demonstrated an OS improvement vs. Ever; ORR also favored in Nivo. | [34] |
CheckMate 025 (Long-term) | 3 | 821 aRCC | Nivo | PD-1 | OS: 25.8 m vs. 19.7 m; 5-year OS: 26% vs. 18%; ORR: 23% vs. 4%; PFS also favored in Nivo. | [35] | |
CLEAR | 3 | 1069 aRCC | Pemb + Lenv | PD-1 + TKIs | PFS: Pemb+Lenv vs. Suni: 23.9 m vs. 9.2 m; Lenv + Ever vs. Suni: 14.7 m vs. 9.2 m. | [37] | |
Checkmate 9ER | 3 | 1003 a/mRCC | Nivo + Cabo/Suni | PD-1 + TKIs | mOS: 37.7 m vs. 34.3 m; mPFS: 16.6 m vs. 8.3 m. | [38] | |
Keynote-426 | 3 | 861 a/mRCC | Pemb + Axit | PD-1 + TKIs | ORR: 59.3% vs. 35.7%; mPFS: 15.1 m vs. 11.1 m. | [39] | |
Checkmate 214 | 3 | 1096 aRCC | Nivo + Ipil | PD-1 + CTLA-4 | OS: ITT (0.59 to 0.81) and I/P (0.54 to 0.78); ORR: ITT (39.1% vs. 32.4%) and I/P (41.9% vs. 26.8%). | [40] | |
COSMIC-313 | 3 | 855 RCC | Nivo + Ipil + Cabo | PD-1 + CTLA-4 + TKIs | 1 year PFS in experimental group vs. control group: 0.57 vs. 0.49. | [41] | |
ADCs | NCT02639182 | 2 | 133 mRCC | AGS-16C3F | ENPP3 | mPFS: 2.9 m vs. 5.7 m; OS: 13.1 m vs.15.4 m. | [44] |
IMMU-132-01 | 2 | 515 cancers (including RCC) | SG | Trop-2 | The clinical benefit rate: 45.4%; mPFS: 5.5 m; OS: 13.0 m. | [46] |