Evidence map›Paper›PMID 35511454›Full record

Trial reportNeuro-oncology2022

Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter.

Michael Lim, Michael Weller, Ahmed Idbaih, Joachim Steinbach, Gaetano Finocchiaro, Raju R Raval, George Ansstas, Joachim Baehring, Jennie W Taylor, Jerome Honnorat and 14 more

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Neuro-oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 367 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
367citing papers in PubMed, 10 pooled it
66.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02667587 phase3completednot on this map

A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma

TypeinterventionalSponsorBristol-Myers SquibbRan2016 to 2024Enrolled716ConditionsBrain NeoplasmsArmsNivolumab, Temozolomide, Radiotherapy, Nivolumab Placebo
NCT07422896 phase1not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Phase I First-in-human Trial of Bvax (B-cell Vaccination) in Addition to Standard of Care Chemoradiotherapy for Newly Diagnosed Glioblastoma

TypeinterventionalSponsorCatalina Lee ChangRan2026 to 2030Enrolled25ConditionsGlioblastomaArmsB-cell vaccination
3 · Its place in the literature

Who cites it

367 citing papers in PubMed, 10 syntheses or guidelines pooled it, 468 citations in OpenAlex.

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  8. Anti-PD-1 and anti-PD-L1 antibodies for glioma.The Cochrane database of systematic reviews · 2025
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  15. Dual Immune Check Point Blockade inJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
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307 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 19 institutions in 7 countries.

Michael LimDepartment of Neurosurgery, Stanford University School of Medicine, Palo Alto, California, USA.
Michael WellerDepartment of Neurology and Brain Tumor Center, University Hospital and University of Zurich, Zurich, Switzerland.ORCID 0000-0002-1748-174X
Ahmed IdbaihSorbonne Université, Institut du Cerveau-Paris Brain Institute-ICM, Inserm, CNRS, AP-HP, Hôpital Universitaire La Pitié Salpêtrière, Paris, France.ORCID 0000-0001-5290-1204
Joachim SteinbachFrankfurt Cancer Institute, Goethe University, Frankfurt, Germany.
Gaetano FinocchiaroUnit of Molecular Neuro-Oncology, Neurological Institute C. Besta, Milan, Italy.ORCID 0000-0003-3583-4040
Raju R RavalTranslational Therapeutics Program, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
George AnsstasDepartment of Medicine, Oncology Division, Washington University Medical School, St. Louis, Missouri, USA.
Joachim BaehringDepartment of Neurology, Yale University School of Medicine, New Haven, Connecticut, USA.
Jennie W TaylorDepartments of Neurology and Neurological Surgery, University of California San Francisco, San Francisco, California, USA.
Jerome HonnoratNeuro-Oncology Department, Hospices Civils de Lyon, SynatAc Team, Institute MeLis, INSERM U1314/CNRS UMR 5284, Université de Lyon, Université Claude Bernard Lyon 1, Lyon, France.ORCID 0000-0002-4721-5952
Kevin PetreccaDepartment of Neurology and Neurosurgery, Brain Tumour Research Centre, Montreal Neurological Institute-Hospital, McGill University, Montreal, Quebec, Canada.
Filip De VosMedical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
Antje WickNeurology Clinic, University of Heidelberg, National Center for Tumor Diseases, Heidelberg, Germany.
Ashley SumrallNeuro-Oncology Department, Levine Cancer Institute, Charlotte, North Carolina, USA.
Solmaz SahebjamMoffitt Cancer Center, University of South Florida, Tampa, Florida, USA.
Ingo K MellinghoffDepartment of Neurology and Human Oncology & Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Masashi KinoshitaDepartment of Neurosurgery, Kanazawa University, Ishikawa, Japan.
Mustimbo RobertsBristol Myers Squibb, Princeton, New Jersey, USA.
Ruta SlepetisBristol Myers Squibb, Princeton, New Jersey, USA.
Deepti WaradBristol Myers Squibb, Princeton, New Jersey, USA.
David LeungBristol Myers Squibb, Princeton, New Jersey, USA.
Michelle LeeSyneos Health, Morrisville, North Carolina, USA.
David A ReardonCenter for Neuro-Oncology, Dana-Farber/Harvard Cancer Center, Boston, Massachusetts, USA.
Antonio OmuroDepartment of Neurology, Yale University School of Medicine, New Haven, Connecticut, USA.
Bristol-Myers Squibb (United States) · USMemorial Sloan Kettering Cancer Center · USCenter for Neuro-Oncology · USCentre National de la Recherche Scientifique · FRGoethe University Frankfurt · DEHeidelberg University · DEKanazawa University · JPLevine Cancer Institute · USMontreal Neurological Institute and Hospital · CAStanford University · USSyneos Health (United States) · USTranslational Therapeutics (United States) · USUniversité Claude Bernard Lyon 1 · FRUniversity of California, San Francisco · USUniversity of South Florida · USUniversity of Zurich · CHUtrecht University · NLWashington University in St. Louis · USYale University · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Molecular Mechanisms of Drug Resistance in Primary Brain TumorsR35NS105109 · NINDS · SLOAN-KETTERING INST CAN RESEARCH · PI MELLINGHOFF, INGO K · 2018 to 2025
$4.7M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA008748NINDS NIH HHS R35 NS105109
6 · The paper itself

Abstract

backgroundNearly 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).

methodsPatients (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.

resultsAs 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.

conclusionsNIVO 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.

Indexed as

Brain NeoplasmsGlioblastomaAdrenal Cortex HormonesAntineoplastic Agents, AlkylatingChemoradiotherapyDNA Modification MethylasesDNA Repair EnzymesHumansNivolumabTemozolomideTumor Suppressor ProteinsAdrenal Cortex HormonesAntineoplastic Agents, AlkylatingDNA Modification MethylasesDNA Repair EnzymesMGMT protein, humanNivolumabTemozolomideTumor Suppressor ProteinsglioblastomaMGMT promoternivolumabPD-L1temozolomide

Identifiers

PMID35511454
PMCPMC9629431
OpenAlexW4225630787

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.