# CheckMate 204

Source: https://onco.cc/trials/checkmate-204/  
OnCo record `checkmate-204` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Registry id: NCT02320058
- Phase: 2
- Setting: Melanoma with untreated brain metastases: nivolumab plus ipilimumab, asymptomatic cohort and a smaller symptomatic cohort
- Sponsor: BMS
- Enrolled: 119
- Result: Intracranial clinical benefit 57% and complete response 26% in the asymptomatic cohort.
- Outcomes: Intracranial clinical benefit rate (asymptomatic cohort): Nivolumab + ipilimumab 57%
- Replication: The ABC trial (Anti-PD1 Brain Collaboration, Australia) found a similar intracranial response rate for the same combination.

## Sources

- ClinicalTrials.gov NCT02320058: https://clinicaltrials.gov/study/NCT02320058
- NEJM 2018: https://www.nejm.org/doi/full/10.1056/NEJMoa1805453
- 3-year follow-up, Lancet Oncology 2021: https://doi.org/10.1016/S1470-2045(21)00545-3

## Connected records

- cancers: [Advanced melanoma (unresectable stage III and stage IV)](https://onco.cc/cancers/advanced-melanoma/), [BRAF V600-mutant melanoma](https://onco.cc/cancers/braf-v600-melanoma/), [Brain metastases (secondary brain tumours)](https://onco.cc/cancers/secondary-brain-tumours/), [Melanoma](https://onco.cc/cancers/melanoma/)
- technologies: [Stereotactic radiosurgery (Gamma Knife, CyberKnife, linac SRS)](https://onco.cc/technologies/radiosurgery-srs/)
- targets: [CTLA-4](https://onco.cc/targets/ctla4/), [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Ipilimumab](https://onco.cc/drugs/ipilimumab/), [Nivolumab](https://onco.cc/drugs/nivolumab/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)
- terms: [Brain metastases (intracranial disease)](https://onco.cc/terms/brain-metastases/)
- people: [Hussein A. Tawbi](https://onco.cc/people/hussein-tawbi/)

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