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Table 1 Anti-PD-1 antibody alone or in combination with other treatments in RCC patients

From: Clinical potential of PD-1/PD-L1 blockade therapy for renal cell carcinoma (RCC): a rapidly evolving strategy

Agents

Phase

Participants

Dose

Outcome

Refs.

Nivolumab Ipilimumab

3

1096

3 mg/kg

1 mg/kg

Better ORR and OS in nivolumab plus ipilimumab arm compared to sunitinib arm (ORR about 75% versus 60%)

[45]

Nivolumab Cabozantinib

3

651

240 mg

40 mg

Better PFS and OS (18.1 months versus 8.3 months) in nivolumab plus ipilimumab arm compared to sunitinib arm

[124]

Nivolumab

3

821

3 mg/kg

Improved OS (25.0 months versus 19.6 months) with lower serious adverse event in nivolumab arm compared to everolimus arm

[22]

Nivolumab Ipilimumab

3

847

3 mg/kg

1 mg/kg

Better patient-reported outcomes (PROs) in dual ICI arms than in sunitinib arm

[212]

Nivolumab Ipilimumab

1

6

3 mg/kg

1 mg/kg

Manageable safety, durable responses with promising OS

[134]

Nivolumab Ipilimumab

CBM588

2

30

3 mg/kg

1 mg/kg

80 mg

Better PFS (12.7 months versus 2.5 months) in dual ICI plus CBM588 compared to nivolumab plus ipilimamab

[141]

Nivolumab Cabozantinib

3

323

240 mg

40 mg

Better PROs in nivolumab plus cabozantinib arm versus sunitinib arm

[213]

Nivolumab

2

720

3 mg/kg

Limited clinical activity

[214]

Nivolumab APX005M Cabiralizumab

1

26

240 mg

0.3 mg/kg

4 mg/kg

Acceptable safety and pharmacodynamic activity

[215]

Nivolumab

3

821

3 mg/kg

10 mg

High levels of CD8 + TILs expressing PD-1 might be a prognostic factor of response to anti-PD-1

[216]

Nivolumab

Mavorixafor

1

9

240 mg

400 mg

Anti-activity and a manageable safety profile

[139]

Nivolumab

4

97

240 mg

Significant ORR (22.7%)

[217]

Nivolumab

–

80

240 mg

Axitinib had superiority over nivolumab in terms of PFS (10.3 months versus 7.3 months)

[132]

Nivolumab

2

73

3 mg/kg

Limited anti-tumor activity

[218]

Nivolumab Bempegaldesleukin

1/2

49

360 mg

0.006 mg/kg

Preliminary anti-tumor activity with the manageable safety profile

[219]

Nivolumab

RT

2

69

240 mg

10 Gy

No significant clinical activity

[220]

Nivolumab Sunitinib Pazopanib

1

33

2 mg/kg

50 mg

800 mg

Higher rates of high-grade toxicities

[138]

Pembrolizumab Axitinib

3

861

200 mg

5 mg

Better OS, PFS, and ORR in the combination arm versus sunitinib arm

[145]

Pembrolizumab Lenvatinib

3

1069

200 mg

20 mg

Longer PFS ( 23.9 versus 9.2 months) and OS in the combination arm versus sunitinib arm

[146]

Pembrolizumab Lenvatinib

1b/2

137

200 mg

20 mg

Manageable safety profile and promising clinical activity

[221]

Pembrolizumab

2

165

200 mg

Significant ORR (26.7%) along with remarkable

PFS (4.2 months) and OS (28.9 months)

[152]

Pembrolizumab Axitinib

1b

11

2 mg/kg

5 mg

The intervention was well tolerated and exhibited clinical activity

[156]

Pembrolizumab Bevacizumab

1b/2

48

200 mg

15 mg/kg

The combination regimen was safe and active

[222]

Pembrolizumab Axitinib

1

-

2 mg/kg

5 mg

Immune-related biomarkers had an intimate association with better ORR and PFS

[223]

Pembrolizumab

RT

1/2

30

200 mg

20 Gy

Robust clinical activity (ORR: 63% and DCR: 83%)

[224]

Pembrolizumab Pegylated IFNÉ‘-2b or Ipilimumab

1b

22

2 mg/kg

2 μg/kg

1 mg/kg

The combination regimen was safe and active

[161]

Toripalimab

1

6

10 mg/kg

Acceptable clinical activity

[225]

  1. Programmed cell death protein 1 (PD-1), Renal cell carcinoma (RCC), Overall survival (OS), Objective response rate (ORR), Progression-free survival (PFS), Disease control rate (DCR), Tumor-infiltrating lymphocytes (TILs), Radiotherapy (RT)