CheckMate 238
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.
Overview
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.
- 70.5 vs 60.8 out of 100 alive without the cancer coming back at 12 months with Nivolumab compared with Ipilimumab 10 mg/kg; 9.7 more per 100.
- Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 35 percent lower chance of the event at any given time (hazard ratio 0.65).
- 51.7 vs 41.2 out of 100 alive without the cancer coming back at 4 years with Nivolumab compared with Ipilimumab 10 mg/kg; 10.5 more per 100.
- Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Resected stage IIIB, IIIC or IV melanoma: one year of adjuvant nivolumab versus ipilimumab 10 mg/kg. People in a different situation may not see the same effect.
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 participants 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% |
Similar pages
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