# CheckMate 548

Source: https://onco.cc/trials/checkmate-548/  
OnCo record `checkmate-548` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

CheckMate 548 added nivolumab to standard radiotherapy and temozolomide in newly diagnosed glioblastoma and found no benefit. With CheckMate 143 and 498 it makes three large negative trials: the immunotherapy that transformed melanoma and lung cancer did nothing in glioblastoma.

## Summary

CheckMate 548, trial NCT02667587 sponsored by BMS, randomised 716 patients with newly diagnosed glioblastoma and a methylated MGMT promoter to nivolumab or placebo added to radiotherapy and temozolomide. Median progression-free survival by blinded central review was 10.6 versus 10.3 months and median overall survival 28.9 versus 32.1 months (HR 1.1, 95% CI 0.9-1.3 for both); grade 3/4 treatment-related adverse events were more frequent with nivolumab (52.4% versus 33.6%). Published by Lim and colleagues in Neuro-Oncology (2022;24:1935-1949). Together with CheckMate 143 (recurrent) and CheckMate 498 (MGMT-unmethylated) it completes three negative phase 3 trials of PD-1 blockade in glioblastoma. Explanations: low mutational burden, T-cell exclusion behind the blood-brain barrier, steroid immunosuppression, systemic lymphopenia. Neoadjuvant PD-1 (Cloughesy 2019) showed immune activation and remains the only encouraging signal.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-17
- Registry id: NCT02667587
- Phase: 3
- Setting: Newly diagnosed glioblastoma with methylated MGMT promoter: nivolumab vs placebo added to radiotherapy and temozolomide
- Sponsor: BMS
- Enrolled: 716
- Result: OS 28.9 vs 32.1 months, HR 1.1 (95% CI 0.9-1.3); no PFS or OS benefit.
- Outcomes: Overall survival, MGMT-methylated glioblastoma: Nivolumab + RT + temozolomide 28.9 months vs Placebo + RT + temozolomide 32.1 months, HR 1.1
- Replication: Consistent with CheckMate 143 and 498: three negative randomised trials of PD-1 blockade in glioblastoma.

## Sources

- ClinicalTrials.gov NCT02667587: https://clinicaltrials.gov/study/NCT02667587
- Lim et al., Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter (Neuro-Oncology 2022): https://doi.org/10.1093/neuonc/noac116

## Connected records

- cancers: [Glioma & glioblastoma](https://onco.cc/cancers/glioblastoma/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Nivolumab](https://onco.cc/drugs/nivolumab/), [Temozolomide](https://onco.cc/drugs/temozolomide/)
- terms: [Blood-brain barrier (BBB)](https://onco.cc/terms/blood-brain-barrier/), [Hot vs cold tumours](https://onco.cc/terms/cold-vs-hot/), [MGMT promoter methylation](https://onco.cc/terms/mgmt/)
- key papers: [Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter](https://onco.cc/key-papers/paper-lim-neuro-oncol/)
- ideas: [Neoadjuvant immunotherapy with surgical window for glioblastoma](https://onco.cc/ideas/idea-neoadjuvant-io-glioblastoma/)
- bottlenecks: [The brain: barrier and sanctuary](https://onco.cc/bottlenecks/b-brain-delivery/)

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