CheckMate 214 is the trial that brought dual immunotherapy to kidney cancer, with a survival advantage still visible eight years later and a fifth of patients in long-term remission.
CheckMate 214, trial NCT02231749 sponsored by Bristol Myers Squibb and reported in 2018, brought dual immunotherapy to kidney cancer, with a survival advantage still visible eight years later and a fifth of patients in long-term remission. It randomised 1,096 patients with untreated advanced clear-cell renal cell carcinoma to nivolumab plus ipilimumab or sunitinib, met its primary overall survival endpoint in intermediate and poor-risk patients with durable benefit at eight years, produced complete responses in about an eighth of patients, many lasting off treatment, and led to FDA approval in April 2018, while favourable-risk patients did not gain survival. It is the comparator for every later first-line trial, and no head-to-head between IO-IO and IO-TKI exists, which is the open question.
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.
1,096 enrolled.
Numbers not yet public.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, intermediate/poor risk (8-year follow-up)primary | Nivolumab + ipilimumab | 425 | - | 0.69 (0.59 to 0.81) | - | link |
| Sunitinib | 422 | - | ||||
| Overall survival, ITT (8-year follow-up) | Nivolumab + ipilimumab | 550 | - | 0.72 (0.62 to 0.83) | - | link |
| Sunitinib | 546 | - |
Shares Sarcomatoid differentiation (RCC), IMDC risk groups (favourable / intermediate / poor), Ipilimumab, Renal cell carcinoma.
Shares Robert J. Motzer, Clear cell renal cell carcinoma, Renal cell carcinoma, Nivolumab.
Shares IMDC risk groups (favourable / intermediate / poor), Robert J. Motzer, Sunitinib, Renal cell carcinoma.
Shares IMDC risk groups (favourable / intermediate / poor), Clear cell renal cell carcinoma, Sunitinib, Renal cell carcinoma.
Shares Clear cell renal cell carcinoma, Renal cell carcinoma, Nivolumab, Immune checkpoint inhibitors.
Shares Robert J. Motzer, Sunitinib, Renal cell carcinoma, Nivolumab.
Shares Ipilimumab, Renal cell carcinoma, Nivolumab, Immune checkpoint inhibitors.
Shares Ipilimumab, Renal cell carcinoma, Nivolumab, Immune checkpoint inhibitors.