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CheckMate 238 showed that a year of nivolumab after melanoma surgery prevents more relapses than the older drug ipilimumab, with far fewer serious side effects, and it made PD-1 blockade the standard adjuvant treatment.
CheckMate 238 randomised 906 patients with completely resected stage IIIB, IIIC or IV melanoma to one year of nivolumab or of high-dose ipilimumab, the adjuvant standard set by EORTC 18071. It was designed to show that PD-1 blockade could match or beat ipilimumab's relapse-free survival benefit with less toxicity.
Twelve-month recurrence-free survival was 70.5 percent with nivolumab against 60.8 percent with ipilimumab (hazard ratio 0.65), and grade 3 or 4 treatment-related adverse events occurred in 14 percent against 46 percent. At four years recurrence-free survival was 51.7 percent against 41.2 percent, while overall survival did not differ, partly because most relapsing patients in both arms went on to effective immunotherapy.
Nivolumab was approved as adjuvant therapy in December 2017 on this trial. With KEYNOTE-054 it established a year of anti-PD-1 antibody as the adjuvant standard for stage III melanoma, later extended to stage II by KEYNOTE-716 and CheckMate 76K and challenged by the neoadjuvant results of SWOG S1801 and NADINA.
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.
906 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Recurrence-free survival at 12 monthsprimary | Nivolumab | 453 | 70.5% | 0.65 | - | link |
| Ipilimumab 10 mg/kg | 453 | 60.8% | ||||
| Recurrence-free survival at 4 years | Nivolumab | 453 | 51.7% | - | - | link |
| Ipilimumab 10 mg/kg | 453 | 41.2% |
A second publication from the CheckMate 238 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
Adjuvant nivolumab (or pembrolizumab) is standard for resected stage III and IV melanoma; ipilimumab is no longer used in the adjuvant setting.
Shares Jeffrey S. Weber, Treat the draining lymph node before removing it, Stage III melanoma (after surgery), Ipilimumab.
Shares Treat the draining lymph node before removing it, Stage III melanoma (after surgery), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), CTLA-4.
Shares Stage III melanoma (after surgery), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), CTLA-4, Neoadjuvant / adjuvant / perioperative.
Shares Treat the draining lymph node before removing it, Stage III melanoma (after surgery), Neoadjuvant / adjuvant / perioperative, Ipilimumab.
Shares Paolo A. Ascierto, CTLA-4, Ipilimumab, Bristol Myers Squibb.
Shares CTLA-4, Ipilimumab, Bristol Myers Squibb, Nivolumab.
Shares CTLA-4, Ipilimumab, Nivolumab, PD-1.
Shares Stage III melanoma (after surgery), CTLA-4, Ipilimumab, Nivolumab.