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. 2022 Mar 20;14(6):1580. doi: 10.3390/cancers14061580

Table 2.

Summary of clinical trials for cancers with FDA-approved use of ipilimumab.

Trial Cancer Treatments Overall Response Rate (%) 1 Overall Survival Rate (%) 2
NCT00094653 [2] Unresectable or
metastatic
melanoma
gp100 (n = 136) 1.5 13.7 (2-yr)
Ipilimumab (3 mg/kg)
(n = 137)
10.9 23.5
Ipilimumab (3 mg/kg) + gp100 (n = 403) 5.7 21.6
NCT01844505 [114] Unresectable or
metastatic melanoma (BRAF V600—wildtype or mutant)
BRAF-wildtype BRAF-mutant
Nivolumab (3 mg/kg) (n-316) 45 22 (6.5-yr) 25 (6.5-yr)
Ipilimumab (3 mg/kg) (n = 315) 19 42 43
Ipilimumab (3 mg/kg) + nivolumab (3 mg/kg) (n = 314) 58 46 57
NCT00636168 [3] Stage III melanoma—adjuvant therapy Placebo (n = 476) N/A 54.4 (5-yr)
Ipilimumab (10 mg/kg) (n = 475) 65.4
NCT02231749 [115] Advanced renal cell carcinoma Sunitinib (n = 422) 26.5 60 (1.5-yr)
Nivolumab (3 mg/kg) +
ipilimumab (1 mg/kg) (n = 425)
41.6 75
NCT02231749 [116] MSI-H/dMMR
metastatic colorectal cancer
Nivolumab (3 mg/kg) +
ipilimumab (1 mg/kg) (n = 119)
55 85 (1-yr)
NCT01658878 [117] Hepatocellular
carcinoma
Nivolumab (1 mg/kg) +
ipilimumab (3 mg/kg) (n = 50)
32 48 (2-yr)
Nivolumab (3 mg/kg) +
ipilimumab (1 mg/kg) (n = 49)
31 30
Nivolumab (3 mg/kg) +
ipilimumab (1 mg/kg) (n = 49)
31 42
NCT02477826 [118] Metastatic NSCLC (≥1% PD-L1) Nivolumab (3 mg/kg) +
ipilimumab (1 mg/kg) (n = 396)
35.9 40 (2-yr)
Platinum-doublet chemotherapy (n = 397) 30 32.8
NCT03215706 [119] Metastatic or
recurrent NSCLC
Nivolumab (360 mg) + ipilimumab (1 mg/kg) + platinum-doublet chemotherapy (n = 361) 38 63 (1-yr)
Platinum-doublet chemotherapy (n = 358) 25 47
NCT02899299 [120] Unresectable
malignant pleural mesothelioma
Nivolumab (3 mg/kg) +
ipilimumab (1 mg/kg) (n = 303)
40 41 (2-yr)
Platinum + pemetrexed
chemotherapy (n = 302)
43 27

1 Values based on blinded independent central review (BICR) assessment if available. 2 Overall survival rate timepoint indicated in brackets.