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CheckMate 204 showed that the nivolumab and ipilimumab combination can shrink melanoma deposits in the brain in more than half of people whose brain metastases are not yet causing symptoms, so many can delay or avoid brain radiotherapy.
CheckMate 204 was a single-arm phase 2 trial of nivolumab plus ipilimumab in melanoma patients with at least one untreated brain metastasis measuring 0.5 to 3 centimetres. Brain metastases had been excluded from the pivotal immunotherapy trials, so whether the combination worked inside the skull was unknown.
In the 94 asymptomatic patients of the first report (NEJM 2018) the rate of intracranial clinical benefit was 57 percent, with complete responses in 26 percent, and intracranial and extracranial responses were concordant. Responses were durable at three years of follow-up. The smaller cohort of symptomatic patients or those needing steroids responded far less often, which is why symptomatic lesions are still treated with radiosurgery or surgery first.
The trial, with the Australian ABC study, changed the sequence for melanoma brain metastases: asymptomatic patients are offered the immunotherapy doublet first and radiosurgery is reserved for lesions that progress.
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.
119 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Intracranial clinical benefit rate (asymptomatic cohort)primary | Nivolumab + ipilimumab | 94 | 57% | - | - | link |
A second publication from the CheckMate 204 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.
This is the paper Europe PMC returns for registry id NCT02320058 with the most citations, so it is the natural first reading for anyone following the CheckMate 204 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares BRAF V600-mutant melanoma, CTLA-4, Advanced melanoma (unresectable stage III and stage IV), Ipilimumab.
Shares CTLA-4, Advanced melanoma (unresectable stage III and stage IV), Ipilimumab, Nivolumab.
Shares CTLA-4, Ipilimumab, Bristol Myers Squibb, Nivolumab.
Shares CTLA-4, Advanced melanoma (unresectable stage III and stage IV), Ipilimumab, Nivolumab.
Shares CTLA-4, Advanced melanoma (unresectable stage III and stage IV), Ipilimumab, Nivolumab.
Shares CTLA-4, Advanced melanoma (unresectable stage III and stage IV), Ipilimumab, PD-1.
Shares BRAF V600-mutant melanoma, CTLA-4, Ipilimumab, Nivolumab.
Shares Hussein A. Tawbi, Advanced melanoma (unresectable stage III and stage IV), Bristol Myers Squibb, Nivolumab.