Evidence map›Paper›PMID 36521103›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma.

Manmeet S Ahluwalia, David A Reardon, Ajay P Abad, William T Curry, Eric T Wong, Sheila A Figel, Laszlo L Mechtler, David M Peereboom, Alan D Hutson, Henry G Withers and 10 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02455557 (A Phase II Study of the Safety and Efficacy of SVN53-67/M57-KLH), which is not on this map. Cited by 113 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
113citing papers in PubMed, 2 pooled it
20.3field-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.

NCT02455557 phase2active not recruitingnot on this map

A Phase II Study of the Safety and Efficacy of SVN53-67/M57-KLH (SurVaxM) in Survivin-Positive Newly Diagnosed Glioblastoma

TypeinterventionalSponsorRoswell Park Cancer InstituteRan2015 to 2026Enrolled66ConditionsGlioblastoma, GliosarcomaArmsLaboratory Biomarker Analysis, Montanide ISA 51 VG, Sargramostim, SVN53-67/M57-KLH Peptide Vaccine, Temozolomide
3 · Its place in the literature

Who cites it

113 citing papers in PubMed, 2 syntheses or guidelines pooled it, 144 citations in OpenAlex.

  1. Pooled it
  2. A systematic review of immunotherapy in high-grade glioma: learning from the past to shape future perspectives.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Pooled it
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53 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

20 authors at 5 institutions in 1 country.

Manmeet S AhluwaliaRose Ella Burkhardt Brain Tumor Center, Cleveland Clinic, Cleveland, OH.ORCID 0000-0003-3794-9511
David A ReardonDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0001-6674-0157
Ajay P AbadDepartment of Neuro-oncology, Roswell Park Comprehensive Cancer Center, Buffalo, NY.
William T CurryMassachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.ORCID 0000-0002-8036-1847
Eric T WongDepartment of Neurology, Beth Israel Deaconess Medical Center, Boston, MA.
Sheila A FigelDepartment of Neurosurgery, Roswell Park Comprehensive Cancer Center, Buffalo, NY.
Laszlo L MechtlerDepartment of Neuro-oncology, Roswell Park Comprehensive Cancer Center, Buffalo, NY.
David M PeereboomRose Ella Burkhardt Brain Tumor Center, Cleveland Clinic, Cleveland, OH.ORCID 0000-0001-7798-5176
Alan D HutsonBiostatistics and Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY.ORCID 0000-0002-7353-5650
Henry G WithersBiostatistics and Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY.ORCID 0000-0002-9746-9352
Song LiuBiostatistics and Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY.
Ahmed N BelalDepartment of Radiology, Roswell Park Comprehensive Cancer Center, Buffalo, NY.
Jingxin QiuDepartment of Pathology, Roswell Park Comprehensive Cancer Center, Buffalo, NY.
Kathleen M MogensenDepartment of Neuro-oncology, Roswell Park Comprehensive Cancer Center, Buffalo, NY.
Sanam S DharmaDepartment of Neurosurgery, Roswell Park Comprehensive Cancer Center, Buffalo, NY.
Andrew DhawanNeurological Institute, Cleveland Clinic, Cleveland, OH.ORCID 0000-0002-5027-1277
Meaghan T BirkemeierDepartment of Neurosurgery, Roswell Park Comprehensive Cancer Center, Buffalo, NY.
Danielle M CasucciDepartment of Neurosurgery, Roswell Park Comprehensive Cancer Center, Buffalo, NY.
Michael J CiesielskiDepartment of Neurosurgery, Roswell Park Comprehensive Cancer Center, Buffalo, NY.ORCID 0000-0002-3373-9421
Robert A FenstermakerDepartment of Neurosurgery, Roswell Park Comprehensive Cancer Center, Buffalo, NY.ORCID 0000-0003-0309-8130
Roswell Park Comprehensive Cancer Center · USCleveland Clinic · USBeth Israel Deaconess Medical Center · USDana-Farber Cancer Institute · USHarvard University · US

Funding

Two-Spirit Films in Indigenous Cancer HealthP30CA016056 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI MARK G FRATTINI · 1985 to 2026
$116.6M
Acquisition of High Performance Data and Computing Infrastructure to Advance Biomedical ResearchS10OD024973 · OD · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI FURLANI, THOMAS · 2019 to 2019
$1.0M
NCI NIH HHS P30 CA016056NIH HHS S10 OD024973
6 · The paper itself

Abstract

purposeDespite intensive treatment with surgery, radiation therapy, temozolomide (TMZ) chemotherapy, and tumor-treating fields, mortality of newly diagnosed glioblastoma (nGBM) remains very high. SurVaxM is a peptide vaccine conjugate that has been shown to activate the immune system against its target molecule survivin, which is highly expressed by glioblastoma cells. We conducted a phase IIa, open-label, multicenter trial evaluating the safety, immunologic effects, and survival of patients with nGBM receiving SurVaxM plus adjuvant TMZ following surgery and chemoradiation (ClinicalTrials.gov identifier: NCT02455557).

methodsSixty-four patients with resected nGBM were enrolled including 38 men and 26 women, in the age range of 20-82 years. Following craniotomy and fractionated radiation therapy with concurrent TMZ, patients received four doses of SurVaxM (500 μg once every 2 weeks) in Montanide ISA-51 plus sargramostim (granulocyte macrophage colony-stimulating factor) subcutaneously. Patients subsequently received adjuvant TMZ and maintenance SurVaxM concurrently until progression. Progression-free survival (PFS) and overall survival (OS) were reported. Immunologic responses to SurVaxM were assessed.

resultsSurVaxM plus TMZ was well tolerated with no serious adverse events attributable to SurVaxM. Of the 63 patients who were evaluable for outcome, 60 (95.2%) remained progression-free 6 months after diagnosis (prespecified primary end point). Median PFS was 11.4 months and median OS was 25.9 months measured from first dose of SurVaxM. SurVaxM produced survivin-specific CD8+ T cells and antibody/immunoglobulin G titers. Apparent clinical benefit of SurVaxM was observed in both methylated and unmethylated patients.

conclusionSurVaxM appeared to be safe and well tolerated. The combination represents a promising therapy for nGBM. For patients with nGBM treated in this manner, PFS may be an acceptable surrogate for OS. A large randomized clinical trial of SurVaxM for nGBM is in progress.

Indexed as

Brain NeoplasmsGlioblastomaAdjuvants, ImmunologicAdultAgedAged, 80 and overAntineoplastic Agents, AlkylatingFemaleHumansMaleMiddle AgedSurvivinTemozolomideVaccines, SubunitYoung AdultAdjuvants, ImmunologicAntineoplastic Agents, AlkylatingSurvivinTemozolomideVaccines, Subunit

Identifiers

PMID36521103
PMCPMC9995096
OpenAlexW4311673768

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.