Evidence map›Paper›PMID 35599302›Full record

ArticleNeurological research and practice2022

AMPLIFY-NEOVAC: a randomized, 3-arm multicenter phase I trial to assess safety, tolerability and immunogenicity of IDH1-vac combined with an immune checkpoint inhibitor targeting programmed death-ligand 1 in isocitrate dehydrogenase 1 mutant gliomas.

Lukas Bunse, Anne-Kathleen Rupp, Isabel Poschke, Theresa Bunse, Katharina Lindner, Antje Wick, Jens Blobner, Martin Misch, Ghazaleh Tabatabai, Martin Glas and 9 more

Registry-linked trialAbstract read
In one paragraph

Article in Neurological research and practice, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03893903 (AMPLIFYing NEOepitope-specific VACcine Responses in Progressive Diffuse Glioma - a Randomized, Open Label, 3 Arm Multicenter Phase I Trial to Assess Safety, Tolerability and Immunogenicity of IDH1R132H-specific Peptide Vaccine in Combination with Checkpoint Inhibitor Avelumab), which is not on this map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing 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.

NCT03893903 phase1completednot on this map

AMPLIFYing NEOepitope-specific VACcine Responses in Progressive Diffuse Glioma - a Randomized, Open Label, 3 Arm Multicenter Phase I Trial to Assess Safety, Tolerability and Immunogenicity of IDH1R132H-specific Peptide Vaccine in Combination with Checkpoint Inhibitor Avelumab

TypeinterventionalSponsorGerman Cancer Research CenterRan2018 to 2024Enrolled69ConditionsMalignant GliomaArmsIDH1R132H peptide vaccine, Avelumab
3 · Its place in the literature

Who cites it

29 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Clinical advancement in the management of mutant isocitrate dehydrogenase (EJC supplements : EJC : official journal of EORTC, European Organization for Research and Treatment of Cancer ... [et al.] · 2026
    Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. IDH mutant high-grade gliomas.Frontiers in molecular neuroscience · 2025
    Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. Article
  20. 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

19 authors.

Lukas BunseDKTK (German Cancer Consortium) Clinical Cooperation Unit (CCU) Neuroimmunology and Brain Tumor Immunology, German Cancer Research Center (DKFZ), Heidelberg, Germany.ORCID http://orcid.org/0000-0002-4490-7574
Anne-Kathleen RuppNational Center for Tumor Diseases (NCT) Trial Center, NCT, Heidelberg, Germany.
Isabel PoschkeDKTK (German Cancer Consortium) Clinical Cooperation Unit (CCU) Neuroimmunology and Brain Tumor Immunology, German Cancer Research Center (DKFZ), Heidelberg, Germany.
Theresa BunseDKTK (German Cancer Consortium) Clinical Cooperation Unit (CCU) Neuroimmunology and Brain Tumor Immunology, German Cancer Research Center (DKFZ), Heidelberg, Germany.
Katharina LindnerDKTK (German Cancer Consortium) Clinical Cooperation Unit (CCU) Neuroimmunology and Brain Tumor Immunology, German Cancer Research Center (DKFZ), Heidelberg, Germany.
Antje WickNeurology Clinic, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany.
Jens BlobnerDepartment of Neurosurgery, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany.
Martin MischDepartment of Neurosurgery, Charité Medical Center, University of Berlin, Berlin, Germany.
Ghazaleh TabatabaiDepartment of Neurology and Interdisciplinary Neuro-Oncology, University Hospital Tübingen, Hertie Institute for Clinical Brain Research, DKTK, DKFZ Partner Site, Eberhard Karls University Tübingen, Tübingen, Germany.
Martin GlasDivision of Clinical Neurooncology, Department of Neurology and (DKTK) Partner Site, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Oliver SchnellDepartment of Neurosurgery, University Hospital Freiburg, Freiburg, Germany.
Jens GemptDepartment of Neurosurgery, Klinikum Rechts Der Isar, School of Medicine, Technical University Munich, Munich, Germany.
Monika DenkInstitute of Cell Biology, Department of Immunology, University of Tübingen, Tübingen, Germany.
Guido ReifenbergerInstitute of Neuropathology, Heinrich Heine University Düsseldorf, Medical Faculty, University Hospital Düsseldorf, Düsseldorf, Germany.
Martin BendszusDepartment of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.
Patrick WuchterInstitute of Transfusion Medicine and Immunology, Medical Faculty Mannheim, Heidelberg University, German Red Cross Blood Service Baden-Württemberg - Hessen, Mannheim, Germany.
Joachim P SteinbachFrankfurt Cancer Institute (FCI), University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany.
Wolfgang WickNeurology Clinic, Heidelberg University Hospital, University of Heidelberg, Heidelberg, Germany.
Michael PlattenDKTK (German Cancer Consortium) Clinical Cooperation Unit (CCU) Neuroimmunology and Brain Tumor Immunology, German Cancer Research Center (DKFZ), Heidelberg, Germany. m.platten@dkfz.de.

Funding

Deutsches Krebsforschungszentrum AMPLIFY-NEOVAC
6 · The paper itself

Abstract

introductionIsocitrate dehydrogenase (IDH) mutations are disease-defining mutations in IDH-mutant astrocytomas and IDH-mutant and 1p/19q-codeleted oligodendrogliomas. In more than 80% of these tumors, point mutations in IDH type 1 (IDH1) lead to expression of the tumor-specific protein IDH1R132H. IDH1R132H harbors a major histocompatibility complex class II (MHCII)-restricted neoantigen that was safely and successfully targeted in a first-in human clinical phase 1 trial evaluating an IDH1R132H 20-mer peptide vaccine (IDH1-vac) in newly diagnosed astrocytomas concomitant to standard of care (SOC).

methodsAMPLIFY-NEOVAC is a randomized, 3-arm, window-of-opportunity, multicenter national phase 1 trial to assess safety, tolerability and immunogenicity of IDH1-vac combined with avelumab (AVE), an immune checkpoint inhibitor (ICI) targeting programmed death-ligand 1 (PD-L1). The target population includes patients with resectable IDH1R132H-mutant recurrent astrocytoma or oligodendroglioma after SOC. Neoadjuvant and adjuvant immunotherapy will be administered to 48 evaluable patients. In arm 1, 12 patients will receive IDH1-vac; in arm 2, 12 patients will receive the combination of IDH1-vac and AVE, and in arm 3, 24 patients will receive AVE only. Until disease progression according to immunotherapy response assessment for neuro-oncology (iRANO) criteria, treatment will be administered over a period of maximum 43 weeks (primary treatment phase) followed by facultative maintenance treatment. PERSPECTIVE: IDH1R132H 20-mer peptide is a shared clonal driver mutation-derived neoepitope in diffuse gliomas. IDH1-vac safely targets IDH1R132H in newly diagnosed astrocytomas. AMPLIFY-NEOVAC aims at (1) demonstrating safety of enhanced peripheral IDH1-vac-induced T cell responses by combined therapy with AVE compared to IDH1-vac only and (2) investigating intra-glioma abundance and phenotypes of IDH1-vac induced T cells in exploratory post-treatment tissue analyses. In an exploratory analysis, both will be correlated with clinical outcome.

trial registrationNCT03893903.

Indexed as

AstrocytomaAvelumabBrain tumorsImmune checkpoint inhibitionIsocitrate dehydrogenase 1OligodendrogliomaPeptide vaccineRecurrent gliomaT cell receptor sequencingWindow-of-opportunity

Identifiers

PMID35599302
PMCPMC9125855

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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.