The DOI matches its Crossref record; 35 of the 35 references it cites were found in a registry or an index.
Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter
Open accessAbstract
Background: Nearly all patients with newly diagnosed glioblastoma experience recurrence following standard-of-care radiotherapy (RT) + temozolomide (TMZ). The purpose of the phase III randomized CheckMate 548 study was to evaluate RT + TMZ combined with the immune checkpoint inhibitor nivolumab (NIVO) or placebo (PBO) in patients with newly diagnosed glioblastoma with methylated MGMT promoter (NCT02667587). Methods: Patients (N = 716) were randomized 1:1 to NIVO [(240 mg every 2 weeks × 8, then 480 mg every 4 weeks) + RT (60 Gy over 6 weeks) + TMZ (75 mg/m2 once daily during RT, then 150-200 mg/m2 once daily on days 1-5 of every 28-day cycle × 6)] or PBO + RT + TMZ following the same regimen. The primary endpoints were progression-free survival (PFS) and overall survival (OS) in patients without baseline corticosteroids and in all randomized patients. Results: As of December 22, 2020, median (m)PFS (blinded independent central review) was 10.6 months (95% CI, 8.9-11.8) with NIVO + RT + TMZ vs 10.3 months (95% CI, 9.7-12.5) with PBO + RT + TMZ (HR, 1.1; 95% CI, 0.9-1.3) and mOS was 28.9 months (95% CI, 24.4-31.6) vs 32.1 months (95% CI, 29.4-33.8), respectively (HR, 1.1; 95% CI, 0.9-1.3). In patients without baseline corticosteroids, mOS was 31.3 months (95% CI, 28.6-34.8) with NIVO + RT + TMZ vs 33.0 months (95% CI, 31.0-35.1) with PBO + RT + TMZ (HR, 1.1; 95% CI, 0.9-1.4). Grade 3/4 treatment-related adverse event rates were 52.4% vs 33.6%, respectively. Conclusions: NIVO added to RT + TMZ did not improve survival in patients with newly diagnosed glioblastoma with methylated or indeterminate MGMT promoter. No new safety signals were observed.
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Cites
Radiotherapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma
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MGMT Gene Silencing and Benefit from Temozolomide in Glioblastoma
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Self-citationInactivation of the DNA-Repair Gene MGMT and the Clinical Response of Gliomas to Alkylating Agents
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EANO guidelines on the diagnosis and treatment of diffuse gliomas of adulthood
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Glioblastoma Therapy: Past, Present and Future
Obrador, E., Moreno-Murciano, P., Oriol-Caballo, M., López-Blanch, R., Pineda, B., Gutiérrez-Arroyo, J., Loras, A., Gonzalez-Bonet, L., Martinez-Cadenas, C., Estrela, J., et al. (2024) · International Journal of Molecular Sciences · doi:10.3390/ijms25052529 · Cited by 271
Neoadjuvant triplet immune checkpoint blockade in newly diagnosed glioblastoma
Long, G. V., Shklovskaya, E., Satgunaseelan, L., Mao, Y., da Silva, I. P., Perry, K. A., Diefenbach, R. J., Gide, T. N., Shivalingam, B., Buckland, M. E., et al. (2025) · Nature Medicine · doi:10.1038/s41591-025-03512-1 · Cited by 83
Self-citationDunkel, I. J., Doz, F., Foreman, N. K., Hargrave, D., Lassaletta, A., André, N., Hansford, J. R., Hassall, T., Eyrich, M., Gururangan, S., et al. (2023) · Neuro-Oncology · doi:10.1093/neuonc/noad031 · Cited by 73
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Metadata
- Authors
- Lim, M., Weller, M., Idbaih, A., Steinbach, J., Finocchiaro, G., Raval, R. R., Ansstas, G., Baehring, J., Taylor, J. W., Honnorat, J., Petrecca, K., De Vos, F., Wick, A., Sumrall, A., Sahebjam, S., Mellinghoff, I. K., Kinoshita, M., Roberts, M., Slepetis, R., Warad, D., Leung, D., Lee, M., Reardon, D. A., & Omuro, A.
- Venue
- Neuro-Oncology
- Publisher
- Oxford University Press (OUP)
- Published
- 2022-05-02
- Volume
- 24
- Issue
- 11
- Pages
- 1935-1949
- ISSN
- 1522-8517 (ISSN-L)
- 1523-5866
- OpenAlex
- W4225630787
- Cited by
- 533
- References
- 35
- FWCI
- 53.40
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Lim, M., Weller, M., Idbaih, A., Steinbach, J., Finocchiaro, G., Raval, R. R., Ansstas, G., Baehring, J., Taylor, J. W., Honnorat, J., Petrecca, K., De Vos, F., Wick, A., Sumrall, A., Sahebjam, S., Mellinghoff, I. K., Kinoshita, M., Roberts, M., Slepetis, R., . . . Omuro, A. (2022). Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. Neuro-Oncology. https://doi.org/10.1093/neuonc/noac116
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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