Clinical studies about nivolumab
| Indication | Study | ||||||||
| Reference & clinical trial | n. | Objective response rate (ORR) % (95%CI) | Treatment-related (TR)all grades adverse events (%) | TR grade 3–4 adverse events (%) | Survival vs. control therapy survival | Control therapy & ORR % (95% CI) | Control therapy TR all grades adverse events (%) | Control therapy TR grade 3–4 adverse events (%) | |
| Unresectable or metastatic melanoma | Weber et al.50
(CHECKMATE- 037) | 120 | 31.7
(23.5–40.8) | 68
(n=268) | 9
(n=268) | 48% vs. 34% (6-month progression-free survival rate) | Chemotherapy 10.6 (3.5–23.1) (n=47) | 80
(n=102) | 32
(n=102) |
| Adjuvant treatment of melanoma | Weber et al.51
(CHECKMATE- 238) | 452 | 96.9 | 25.4 | 70.5% vs. 60.8% (12-month recurrence-free survival rate) | Ipilimumab | 98.5 | 55.2 | |
| Metastatic non-small cell lung cancer | Brahmer et al.34
(CHECKMATE- 017) | 135 | 20
(14–28) | 58
(n=131) | 7
(n=131) | 9.2 months vs. 6.0 months (median overall survival) | Docetaxel 9 (5–15) (n=137) | 86
(n=129) | 55
(n=129) |
| Renal cell carcinoma | Motzer et al.52
(CHECKMATE- 025) | 410 | 25 | 79
(n=406) | 19
(n=406) | 25.0 months vs. 19.6 months (median overall survival) | Everolimus 5 (n=411) | 88
(n=397) | 37
(n=397) |
| Classical Hodgkin's lymphoma | Younes et al.53
(CHECKMATE- 205) | 80 | 66.3
(54.8–76.4) | 89 | 25 | 76·9% (6-month progression-free survival rate) | |||
| Recurrent or metastatic squamous cell carcinoma of the head and neck | Ferris et al.54
(CHECKMATE- 141) | 240 | 13.3 | 58.9
(n=236) | 13.1
(n=236) | 7.5 months vs. 5.1 months (median overall survival) | Standard therapy 5.8 (n=121) | 77.5
(n=111) | 35.1
(n=111) |
| Locally advanced or metastatic urothelial carcinoma | Sharma et al.55
(NCT02387996) | 270 | 19.6
(15.0–24.9) (n=265) | 64 | 18 | 8.74 months (median overall survival) | |||
| Hepatocellular carcinoma | El-Khoueiry
et al.56 (CHECKMATE- 040) | 214 | 20
(15–26) | 19 | 83% (6-month overall survival rate) | ||||
| MSI-H/dMMR metastatic colorectal cancer | Overman et al.57
(CHECKMATE- 142) | 74 | 31.1
(20.8–42.9) | 70 | 21 | 14.3 months (median progression-free survival) | |||