Evidence map›Paper›PMID 40800123›Full record

ArticleNeuro-oncology advances

Ipilimumab with temozolomide vs. temozolomide alone after surgery and chemoradiotherapy in recently diagnosed glioblastoma: a randomized phase II clinical trial.

Nicholas F Brown, Catherine McBain, Lucy Brazil, Sharon Peoples, Sarah Jefferies, Fiona Harris, Anup Vinayan, Puneet Plaha, Claire Brooks, Samia Hussain and 6 more

Abstract read
In one paragraph

Article in Neuro-oncology advances. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

16 authors.

Nicholas F BrownDepartment of Medical Oncology, University College London Hospitals, London, UK.ORCID https://orcid.org/0000-0002-9036-884X
Catherine McBainDepartment of Clinical Oncology, The Christine NHS Foundation Trust, Manchester, UK.
Lucy BrazilDepartment of Clinical Oncology, Guys and St Thomas' NHS Foundation Trust, London, UK.
Sharon PeoplesEdinburgh Centre for Neuro-Oncology, Western General Hospital Edinburgh Cancer Centre, Edinburgh, UK.
Sarah JefferiesDepartment of Clinical Oncology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Fiona HarrisDepartment of Clinical Oncology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Anup VinayanDepartment of Clinical Oncology, Mount Vernon Cancer Centre, Northwood, UK.
Puneet PlahaNuffield Department of Surgical Sciences, Oxford University Hospitals, Oxford, UK.
Claire BrooksOncology Clinical Trials Office (OCTO), Department of Oncology, The University of Oxford, Oxford, UK.
Samia HussainOxford Clinical Trials Research Unit, Centre for Statistics in Medicine (CSM), University of Oxford, Botnar Research Centre, Oxford, UK.
Susan J DuttonOxford Clinical Trials Research Unit, Centre for Statistics in Medicine (CSM), University of Oxford, Botnar Research Centre, Oxford, UK.
Jonathan CookOxford Clinical Trials Research Unit, Centre for Statistics in Medicine (CSM), University of Oxford, Botnar Research Centre, Oxford, UK.ORCID https://orcid.org/0000-0002-4156-6989
Stasya M NgOncology Clinical Trials Office (OCTO), Department of Oncology, The University of Oxford, Oxford, UK.
Stephanie LevyOncology Clinical Trials Office (OCTO), Department of Oncology, The University of Oxford, Oxford, UK.
Timothy CouttsOncology Clinical Trials Office (OCTO), Department of Oncology, The University of Oxford, Oxford, UK.
Paul MulhollandGlioblastoma Research Group, UCL Cancer Institute, London, UK.ORCID https://orcid.org/0000-0002-7926-824X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Glioblastoma confers a bleak prognosis, with median survival of less than a year. This trial evaluated whether addition of the CTLA-4 immune checkpoint inhibitor ipilimumab to standard therapy improves survival in patients with recently diagnosed glioblastoma. Methods: Ipi-Glio was a stratified randomized, open-label, multicenter, academic phase II study. Patients with recently diagnosed de novo glioblastoma following completion of chemoradiotherapy were randomized 2:1 to ipilimumab + temozolomide (Arm A) vs temozolomide alone (Arm B), stratified to extent of surgery and MGMT promotor methylation. Primary endpoint was overall survival. Secondary endpoints included progression-free survival at 18 months, overall survival at 3 years, and toxicity (≥Grade 3). Results: One hundred nineteen patients were randomized (79 to Arm A, 40 to Arm B). Patient characteristics (Arm A vs B): median age 57 vs 49 years; male sex 70 vs 65%, gross total resection 61 vs 60%, tumor MGMT promotor methylation 39 vs 40%. Median overall survival was 18 months (60% CI 16.0, 23.9) in Arm A vs 23.0 months (17.3, 26.4) in Arm B (adjusted HR 1.09, 60% CI 0.86,1.38, one-sided Conclusions: No benefit was observed with the addition of ipilimumab to temozolomide in patients with recently diagnosed glioblastoma following chemoradiotherapy. This study does not support further investigation of this regimen in this setting. Trial Registration: ISRCTN84434175 (www.isrctn.com/ISRCTN84434175).

Indexed as

checkpoint inhibitorclinical trialglioblastomaimmunotherapyipilimumab

Identifiers

PMID40800123
PMCPMC12342986

What OpenQuestion holds

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Registered trials

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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.