CheckMate 204
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.
Overview
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.
- 57 out of 100 people reached this endpoint with Nivolumab + ipilimumab.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Melanoma with untreated brain metastases: nivolumab plus ipilimumab, asymptomatic cohort and a smaller symptomatic cohort. 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.
119 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Intracranial clinical benefit rate (asymptomatic cohort)primary | Nivolumab + ipilimumab | 94 | 57% | - | - | link |
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