Evidence map›Paper›PMID 38874333›Full record

ArticleNeuro-oncology2024

NRG-BN002: Phase I study of ipilimumab, nivolumab, and the combination in patients with newly diagnosed glioblastoma.

Andrew E Sloan, Kathryn Winter, Mark R Gilbert, Kenneth Aldape, Serah Choi, Patrick Y Wen, Nicholas Butowski, Fabio M Iwamoto, Raju R Raval, Alfredo D Voloschin and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Neuro-oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02311920 (Phase I Study of Ipilimumab, Nivolumab, and the Combination in Patients With Newly Diagnosed Glioblastoma), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
–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.

NCT02311920 phase1completednot on this map

Phase I Study of Ipilimumab, Nivolumab, and the Combination in Patients With Newly Diagnosed Glioblastoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2015 to 2022Enrolled32ConditionsGliosarcoma, Supratentorial GlioblastomaArmsIpilimumab, Laboratory Biomarker Analysis, Nivolumab, Temozolomide
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Anti-PD-1 and anti-PD-L1 antibodies for glioma.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Dual Immune Check Point Blockade inJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Trial
  3. Abundant CD8British journal of cancer · 2026
    Article
  4. Review
  5. Review
  6. Review
  7. Advances and challenges in glioblastoma immunotherapy: a meta-analysis of immune checkpoint inhibitors.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  8. Reply to: Blood-Brain Barrier Heterogeneity in NRG BN007: Implications for Immunotherapy Delivery.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
    Article
  9. The Application of PD-1 Inhibitors in Immunotherapy for Glioblastoma.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
    Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Current Status and Evolution of Immunotherapy in Glioma Management.International journal of medical sciences · 2026
    Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review
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

13 authors.

Andrew E SloanPiedmont Healthcare, Atlanta, Georgia, USA.
Kathryn WinterNRG Oncology Statistics and Data Management Center/ACR, Philadelphia, Pennsylvania, USA.
Mark R GilbertLaboratory of Pathology, National Cancer Institute, Bethesda, Maryland, USA.ORCID 0000-0003-2556-9722
Kenneth AldapeLaboratory of Pathology, National Cancer Institute, Bethesda, Maryland, USA.ORCID 0000-0001-5119-7550
Serah ChoiCase Western Reserve University & Case Comprehensive Cancer Center, Cleveland, Ohio, USA.
Patrick Y WenDana-Farber/Harvard Cancer Center, Boston, Massachusetts, USA.ORCID 0000-0002-0774-7700
Nicholas ButowskiUCSF Medical Center-Mount Zion, San Francisco, California, USA.
Fabio M IwamotoColumbia University Minority Underserved NCORP, New York, New York, USA.
Raju R RavalOhio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Alfredo D VoloschinEmory University Hospital/Winship Cancer Institute, Atlanta, Georgia, USA.
Carlos Kamiya-MatsuokaMD Anderson Cancer Center, Houston, Texas, USA.
Minhee WonNRG Oncology Statistics and Data Management Center/ACR, Philadelphia, Pennsylvania, USA.
Minesh P MehtaMiami Cancer Institute, Miami, Florida, USA.

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868
6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors (ICIs) have efficacy in several solid tumors but limited efficacy in glioblastoma (GBM). This study evaluated the safety of anti-CTLA-4 and anti-PD-1 ICIs alone or in combination in newly diagnosed GBM after completion of standard radiochemotherapy with the subsequent intent to test combinatorial ICIs in this setting.

methodsThe primary endpoint was dose-limiting toxicity (DLT) for adults with unifocal, supratentorial newly diagnosed GBM after resection and chemoradiation. Ipilimumab and nivolumab were tested separately and in combination with a planned expansion cohort dependent upon DLT results.

resultsThirty-two patients were enrolled at 9 institutions: 6 to each DLT assessment cohort and 14 to the expansion cohort. Median age: 55 years, 67.7% male, 83.9% White. Treatment was well tolerated with 16% Grade 4 events; the combination did not have unexpectedly increased toxicity, with no Grade 5 events. One DLT was seen in each single-agent treatment; none were observed in the combination, leading to expanded accrual of the combined treatment. The median follow-up was 19.6 months. For all patients receiving combination treatment, median overall survival (OS) and progression-free survival (PFS) were 20.7 and 16.1 months, respectively.

conclusionsIPI and NIVO are safe and tolerable with toxicities similar to those noted with other cancers when given in combination with adjuvant temozolomide for newly diagnosed GBM. Combination IPI + NIVO is not substantially more toxic than single agents. These results support a subsequent efficacy trial to test the combination of ICIs in Phase II/III for patients with newly diagnosed GBM. CLINICALTRIALS.GOV REGISTRATION: NCT02311920.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsGlioblastomaIpilimumabNivolumabAdultAgedChemoradiotherapyFemaleFollow-Up StudiesHumansMaleMiddle AgedPrognosisSurvival RateIpilimumabNivolumabGBMimmune checkpoint inhibitoripilimumabnivolumabPhase I

Identifiers

PMID38874333
PMCPMC11376446

What OpenQuestion holds

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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.