πŸ§ͺ AMPLIFY-NEOVAC Trial

The AMPLIFY-NEOVAC Trial is a Phase I multicenter clinical trial investigating the combination of an IDH1 R132H-targeted peptide vaccine with an anti–PD-L1 immune checkpoint inhibitor in patients with newly diagnosed IDH1-mutant astrocytomas.

To evaluate the safety, tolerability, and immunogenicity of a combination immunotherapy:

  1. IDH1 R132H peptide vaccine (used in the NOA-16 trial)
  2. Atezolizumab (a PD-L1 immune checkpoint inhibitor)
  • Adults with newly diagnosed WHO grade III or IV IDH1 R132H-mutant astrocytomas
  • Must have completed standard-of-care therapy (surgery and radiotherapy)
  • Patients with or without prior temozolomide exposure may be included
  • NOA-16 showed the IDH1 R132H vaccine is safe and immunogenic
  • Adding a PD-L1 inhibitor may enhance T cell infiltration and sustain immune responses by preventing T cell exhaustion
  • The goal is to amplify anti-tumor immunity and improve long-term outcomes
  • Open-label, Phase I
  • Two arms:
    1. IDH1 vaccine alone
    2. IDH1 vaccine + atezolizumab
  • Evaluates:
    1. Adverse events
    2. Vaccine-specific T cell responses
    3. Tumor progression-free survival (PFS)
  • Atezolizumab is already approved for several cancers (lung, bladder) and blocks PD-L1 β†’ PD-1 signaling
  • The vaccine uses the same 20-mer peptide from NOA-16, targeting the IDH1 R132H mutation
  • The trial will help determine if combining checkpoint blockade with vaccination improves response durability
  1. Immune-related adverse events due to checkpoint inhibition
  2. Blood-brain barrier may limit immune cell access
  3. Small patient population (IDH1-mutant astrocytomas are rare)
  • NOA-16 demonstrated feasibility and immune activation using the IDH1 vaccine alone
  • AMPLIFY-NEOVAC builds on this by aiming to strengthen and prolong the anti-tumor immune response

The AMPLIFY-NEOVAC Trial is an important next step in personalized glioma immunotherapy, exploring whether checkpoint blockade can synergize with neoantigen vaccination to generate deeper, longer-lasting anti-tumor responses in patients with IDH1 R132H-mutant gliomas.

If you're studying feasibility and safety of personalized vaccines β†’ NOA-16 is essential.

If you're interested in advanced therapeutic strategies and combination immunotherapy β†’ AMPLIFY-NEOVAC is more cutting-edge. 1)


1)
Bunse L, Rupp AK, Poschke I, Bunse T, Lindner K, Wick A, Blobner J, Misch M, Tabatabai G, Glas M, Schnell O, Gempt J, Denk M, Reifenberger G, Bendszus M, Wuchter P, Steinbach JP, Wick W, Platten M. 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. Neurol Res Pract. 2022 May 23;4(1):20. doi: 10.1186/s42466-022-00184-x. PMID: 35599302; PMCID: PMC9125855.
  • amplify-neovac_trial.txt
  • Last modified: 2025/03/26 07:28
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