Evidence map›Paper›PMID 29106665›Full record

Trial reportNeuro-oncology2018

Nivolumab with or without ipilimumab in patients with recurrent glioblastoma: results from exploratory phase I cohorts of CheckMate 143.

Antonio Omuro, Gordana Vlahovic, Michael Lim, Solmaz Sahebjam, Joachim Baehring, Timothy Cloughesy, Alfredo Voloschin, Shakti H Ramkissoon, Keith L Ligon, Robert Latek and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Neuro-oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05235737 (A Single Center, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of Neoadjuvant and Adjuvant Pembrolizumab on Top of Standard Chemo-Radiotherapy), which is not on this map. Cited by 319 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
319citing papers in PubMed, 10 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.

NCT05235737 phase4unknown statusnot on this mapstarted 2022, after this paper: background citation

A Single Center, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of Neoadjuvant and Adjuvant Pembrolizumab on Top of Standard Chemo-Radiotherapy (Stupp Protocol) in Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme (GBM).

TypeinterventionalSponsorMedical University of SilesiaRan2022 to 2026Enrolled36ConditionsNewly Diagnosed GlioblastomaArmsPembrolizumab
3 · Its place in the literature

Who cites it

319 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Anti-PD-1 and anti-PD-L1 antibodies for glioma.The Cochrane database of systematic reviews · 2025
    Pooled it
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  8. Molecular Biomarker Testing for the Diagnosis of Diffuse Gliomas.Archives of pathology & laboratory medicine · 2022
    Guideline
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259 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

16 authors.

Antonio OmuroMemorial Sloan Kettering Cancer Center, New York, New York.
Gordana VlahovicDuke University Medical Center, Durham, North Carolina.
Michael LimThe Johns Hopkins Hospital, Baltimore, Maryland.
Solmaz SahebjamMoffitt Cancer Center, University of South Florida, Tampa, Florida.
Joachim BaehringYale School of Medicine, New Haven, Connecticut.
Timothy CloughesyUniversity of California Los Angeles, Los Angeles, California.
Alfredo VoloschinEmory University School of Medicine, Atlanta, Georgia.
Shakti H RamkissoonDana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Keith L LigonDana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Robert LatekBristol-Myers Squibb, Princeton, New Jersey.
Ricardo ZwirtesBristol-Myers Squibb, Princeton, New Jersey.
Lewis StraussBristol-Myers Squibb, Princeton, New Jersey.
Prashni PaliwalBristol-Myers Squibb, Princeton, New Jersey.
Christopher T HarbisonBristol-Myers Squibb, Princeton, New Jersey.
David A ReardonDana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
John H SampsonDuke University Medical Center, Durham, North Carolina.

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
UCLA SPORE in Brain CancerP50CA211015 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Yvonne Yu-Hsuan Chen · 2017 to 2026
$25.2M
Clinical Neuroimmunology of Vaccines in Brain TumorsR01NS116888 · NINDS · DUKE UNIVERSITY · PI LI, QIJING, SAMPSON, JOHN H. · 2021 to 2022
$802k
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA211015NINDS NIH HHS R01 NS116888Wellcome Trust
6 · The paper itself

Abstract

Background: Immunotherapies have demonstrated efficacy across a diverse set of tumors supporting further evaluation in glioblastoma. The objective of this study was to evaluate the safety/tolerability and describe immune-mediated effects of nivolumab ± ipilimumab in patients with recurrent glioblastoma. Exploratory efficacy outcomes are also reported. Methods: Patients were randomized to receive nivolumab 3 mg/kg every 2 weeks (Q2W; NIVO3) or nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks (Q3W) for 4 doses, then nivolumab 3 mg/kg Q2W (NIVO1+IPI3). An alternative regimen of nivolumab 3 mg/kg + ipilimumab 1 mg/kg Q3W for 4 doses, then nivolumab 3 mg/kg Q2W (NIVO3+IPI1) was investigated in a nonrandomized arm. Results: Forty patients were enrolled (NIVO3, n = 10; NIVO1+IPI3, n = 10; NIVO3+IPI1, n = 20). The most common treatment-related adverse events (AEs) were fatigue (NIVO3, 30%; NIVO1+IPI3, 80%; NIVO3+IPI1, 55%) and diarrhea (10%, 70%, 30%, respectively). AEs leading to discontinuation occurred in 10% (NIVO3), 30% (NIVO1+IPI3), and 20% (NIVO3+IPI1) of patients. Three patients achieved a partial response (NIVO3, n = 1; NIVO3+IPI1, n = 2) and 8 had stable disease for ≥12 weeks (NIVO3, n = 2; NIVO1+IPI3, n = 2; NIVO3+IPI1, n = 4 [Response Assessment in Neuro-Oncology criteria]). Most patients (68%) had tumor-cell programmed death ligand-1 expression ≥1%. Immune-mediated effects mimicking radiographic progression occurred in 2 patients. Conclusions: Nivolumab monotherapy was better tolerated than nivolumab + ipilimumab; the tolerability of the combination was influenced by ipilimumab dose. These safety and exploratory findings merit further investigation of immunotherapies in glioblastoma.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsCohort StudiesFemaleFollow-Up StudiesGlioblastomaHumansIpilimumabMaleMiddle AgedNeoplasm Recurrence, LocalNivolumabPrognosisIpilimumabNivolumab

Identifiers

PMID29106665
PMCPMC5892140

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.