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Table 3 Immune-related toxicity data reported in front-line combinations with ICIs in advanced RCC Clinical Trials

From: The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of advanced renal cell carcinoma (RCC)

 CheckMate 214
Nivolumab + Ipilimumab
(NCT02231749) [9]
(n = 547)
Keynote-426
Pembrolizumab + Axitinib
(NCT02853331)
[11]
(n = 429)
Javelin RENAL 101
Avelumab + Axitinib
(NCT02684006)
[12, 13]
(n = 434)
IMmotion151
Atezolizumab + Bevacizumab
(NCT02420821)
[14]
(n = 451)
CheckMate 025
Nivolumab
(NCT01668784)
[16]
(n = 406)
Number of patients (%) 
Total EventsAny TRAE509 (93)422 (98.4)432 (95.4)411 (91)319 (79)
Grade 3–4 TRAEs250 (46)270 (63)309 (56.7)182 (40)76 (19)
TRAEs leading to discontinuation of either drug131 (30.5)Atezolizumab: 9 (2);
Bevacizumab: 23 (5)
31 (8)
TRAEs leading to discontinuation of both drugs118 (22)45 (10.7)33 (7.6)24 (5)
Treatment related deaths8 (1.5)4 (0.9)3 (0.7)5 (1.1)0
Most Common AEs
(Any Grade)
Fatigue202 (37)165 (38.5)180 (41.5) 134 (33)
Pruritus154 (28) 61 (14.1) 57 (14)
Diarrhea145 (27)233 (54.3)270 (62.2) 50 (12)
Hypertension12 (2)191 (44.5)215 (49.5) 
Rash118 (22)61 (14.2)62 (14.3) 41 (10)
Nausea109 (20)119 (27.7)148 (34.1) 57 (14)
Increased lipase90 (16) 
Hypothyroidism85 (16)152 (35.4)108 (24.9) 
Palmar-plantar erythrodysesthesia5 (< 1)120 (28.0)145 (33.4) 
Most Common TRAEs (Grade 3–4)Fatigue23 (4)12 (2.8)15 (3.5) 10 (2)
Diarrhea21 (4)39 (9.1)29 (6.7) 5 (1)
Hypertension4 (< 1)95 (22.1)111 (25.6)63 (14)
Increased lipase56 (10) 
Palmar-plantar erythrodysesthesia022 (5.1)25 (5.8) 
Alanine aminotransferase increased57 (13.3)26 (6.0) 
Aspartate aminotransferase increased30 (7.0)17 (3.9)