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CheckMate 025 was the trial that brought immunotherapy to kidney cancer: nivolumab helped people live longer than everolimus after anti-angiogenic drugs had failed, with fewer side effects.
CheckMate 025 randomised 821 patients with advanced clear cell renal cell carcinoma who had received one or two prior anti-angiogenic regimens to nivolumab or to everolimus, then the standard second-line drug. The primary endpoint was overall survival.
Nivolumab lengthened overall survival and produced more objective responses than everolimus, regardless of PD-L1 expression, with fewer grade 3 to 4 adverse events and better quality of life. It was approved in the United States in November 2015, the first checkpoint inhibitor in kidney cancer, and the combinations of nivolumab with ipilimumab or cabozantinib that followed (CheckMate 214 and 9ER) moved immunotherapy into first line.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
821 enrolled.
98.5% CI for the hazard ratio; 821 randomised 1:1
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Nivolumab 3 mg/kg | - | 25 months | 0.73 (0.57 to 0.93) | 0.002 | link |
| Everolimus 10 mg | - | 19.6 months | ||||
| Objective response rate | Nivolumab 3 mg/kg | - | 25% | - | <0.001 | link |
| Everolimus 10 mg | - | 5% | ||||
| Progression-free survival | Nivolumab 3 mg/kg | - | 4.6 months | 0.88 (0.75 to 1.03) | 0.11 | link |
| Everolimus 10 mg | - | 4.4 months | ||||
| Grade 3-4 treatment-related adverse events | Nivolumab 3 mg/kg | - | 19% | - | - | link |
| Everolimus 10 mg | - | 37% |
Shares Bristol Myers Squibb, Nivolumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Clear cell renal cell carcinoma, Renal cell carcinoma and the tag subtype-trials.
Shares Bristol Myers Squibb, Nivolumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Clear cell renal cell carcinoma, Bristol Myers Squibb, Renal cell carcinoma, Nivolumab.
Shares Bristol Myers Squibb, Nivolumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Bristol Myers Squibb, Nivolumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Bristol Myers Squibb and the tag subtype-trials.
Shares Bristol Myers Squibb and the tag subtype-trials.