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Video

Clinical trials: Immunologic

Session: Abstract Concurrent Session: Clinical Trials - Immunologic

CTIM-18 - NRG Oncology Study BN007: Randomized phase II/III trial of ipilimiumab (Ipi) plus nivolumab (Nivo) vs. temozolomide (TMZ) in MGMT-unmethylated (uMGMT) newly diagnosed glioblastoma (nGBM)

Friday, November 17, 2023
7:15 AM - 7:25 AM PT
Location: Room 109-110
Non-CME

    Oral Abstract Presenter(s)

  • Andrew B. Lassman

    Columbia University Vagelos College of Physicians and Surgeons and New York Presbyterian Hospital
    New York, New York, United States

    • Author(s)

  • MP

    Mei-Yin C. Polly

    NRG Oncology Statistics and Data Management Center
    Philadelphia, Pennsylvania, United States

  • FI

    Fabio M. Iwamoto

    Division of Neuro-Oncology, New York-Presbyterian/Columbia University Medical Center
    New York, New York, United States

  • AS

    Andrew E. Sloan

    Piedmont Health
    Atlanta, Georgia, United States

  • TW

    Tony JC Wang

    Division of Department of Radiation Oncology (in Neurological Surgery) and Herbert Irving Comprehensive Cancer Center, Columbia University Vagelos College of Physicians and Surgeons and NewYork-Presbyterian
    New York, New York, United States

  • Kenneth D. Aldape

    Laboratory of Pathology, National Cancer Institute, NIH
    Bethesda, Maryland, United States

  • Jeffrey S. Wefel

    The University of Texas MD Anderson Cancer Center
    Houston, Texas, United States

  • Vinai Gondi

    Northwestern Medicine Cancer Center Warrenville
    Warrenville, Illinois, United States

  • AG

    Alonson N. Gutierrez

    Miami Cancer Institute
    Miami, Florida, United States

  • MM

    Mohammed Manasawala

    WellSpan Health-York Cancer Center
    York, Pennsylvania, United States

  • Mark R. Gilbert

    National Cancer Institute, National Institutes of Health
    Bethesda, Maryland, United States

  • Erik P. Sulman

    New York University Grossman School of Medicine, Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
    New York, New York, United States

  • JW

    Jedd D. Wolchok

    Meyer Cancer Center, Weill Cornell Medicine
    New York, New York, United States

  • Richard M. Green

    Kaiser Permanente-Los Angeles Medical Center, Accrual for Kaiser Permanente NCI Community Oncology Research Program
    Los Angeles, New York, United States

  • Elizabeth C. Neil

    M Health Fairview Cancer Center, Accruals for Metro Minnesota Community Oncology Research Consortium
    Minneapolis, Minnesota, United States

  • Rimas V. Lukas

    Department of Neurology, Northwestern University
    Chicago, Illinois, United States

  • SG

    Samuel A. Goldlust

    Saint Luke’s Marion Bloch Neuroscience Institute
    Kansas, United States

  • Matija Snuderl

    New York University
    New York, New York, United States

  • JD

    James Dignam

    NRG Oncology Statistics and Data Management Center
    Philadelphia, Pennsylvania, United States

  • MW

    Minhee Won

    NRG Oncology Statistics and Data Management Center
    Philadelphia, Pennsylvania, United States

  • BM

    Benjamin Movsas

    Henry Ford Hospital
    Detroit, Michigan, United States

  • Minesh P. Mehta

    Miami Cancer Institute
    Miami, Florida, United States


Background: New therapies are especially needed for uMGMT nGBM. NRG Oncology BN002 (phase I) demonstrated safety and preliminary efficacy of Ipi+Nivo for nGBM, leading to BN007 as phase II/III.

Methods: Adults with uMGMT nGBM (WHO 2016) and KPS ≥ 70 were randomized to RT and concurrent and adjuvant Ipi+Nivo or TMZ, stratified by glioma-recursive partitioning analysis class (RPA), intent to use tumor-treating fields (NCT04396860). Phase II primary endpoint was progression-free survival (PFS), powered 95% to detect a hazard ratio (HR) ≤0.58 with 1-sided 0.15 significance after 100 events. If p< 0.15, then phase III would accrue with overall survival (OS) as primary endpoint. Corticosteroids were disallowed at Ipi+Nivo start. Histology, biomarkers, and PFS were assessed centrally.

Results: Among 374 patients screened, 159 were randomized in phase II (79 Ipi+Nivo, 80 TMZ). Demographics (age median 60 years, range 28-79; male 66%, white 88%, not Hispanic/Latino 89%), KPS (90-100 61%), extent of resection (gross total 65% per local PI), and RPA (III 10%, IV 73%, V 17%) were well-balanced between arms. After 100 PFS events, the pre-planned phase II analysis demonstrated no improvement for Ipi+Nivo vs. TMZ [median 7.7 (95% CI: 6.5, 8.5) vs. 8.5 (95% CI: 7.1, 10.4) months; HR 1.47 (95% CI: 0.98-2.2); 1-sided p=0.96]. OS is immature ( >50% alive, 13.7 months median follow-up) but without observed difference between arms [median ~13 months each; HR 0.95 (95% CI: 0.61-1.49); 1-sided p=0.36]. On the Ipi+Nivo arm, treatment-related grade 3, 4, and 5 events were reported in 26 (33.3%), 4 (5.1%), and 2 (2.6%; colitis and autoimmune disorder, n=1 each) patients.

Conclusions: Ipi+Nivo did not improve PFS for uMGMT nGBM. Accrual permanently closed after phase II. No new safety signals were identified. Molecular analyses and survival follow-up are ongoing.

Funding: NCI Grants U10CA180868, U10CA180822, U24CA196067 (NRG Oncology Operations, SDMC, Specimen Bank).