Table 1 Clinical trials of ICIs, ADCs, and their combined application in RCC.

From: The combination of immune checkpoint inhibitors and antibody-drug conjugates in the treatment of urogenital tumors: a review insights from phase 2 and 3 studies

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]