Phase I Trial of IDH1 Peptide Vaccine in IDH1R132H-mutated Grade III-IV Gliomas

Summary

The NOA-16 trial is the first-in-man trial of the IDH1 (isocitrate dehydrogenase type 1) peptide vaccine targeting the IDH1R132H mutation (amino acid exchange from arginine to glutamine at position 132 of IDH1). The aim of this trial is to evaluate the safety and tolerability of and immune response to the IDH1 peptide vaccine in patients with IDH1R132H-mutated, WHO grade III-IV gliomas.

Timeline

Start

2015-06

Primary completion

2017-09-19

Completion

2017-09-19

Outcome

Met primary endpoint

paper A multicenter, first-in-human phase 1 trial met its prespecified primary endpoints by demonstrating safety and immunogenicity of an IDH1-R132H peptide vaccine PMID 42387024 ↗

Publications

• Bunse L, Lindner K, Wick A, Freitag A, Lanz LM, Edelmann D, Suwala A, Breckwoldt MO, Harting I, Sahm F, Schlenk RF, Schmitt A, Schnell O, Hense J, Misch M, Krex D, Denk M, Walz J, Steinbach JP, von Deimling A, Schmitt M, Bunse T, Tabatabai G, Bendszus M, Poschke I, Wick W, Platten M. IDH1-mutant vaccine in newly diagnosed astrocytoma: final analysis of the multicenter, single-arm, open-label, first-in-human phase 1 NOA16 trial. Nat Cancer. 2026 Jul 1. doi: 10.1038/s43018-026-01199-y. Online ahead of print.
• Platten M, Bunse L, Wick A, Bunse T, Le Cornet L, Harting I, Sahm F, Sanghvi K, Tan CL, Poschke I, Green E, Justesen S, Behrens GA, Breckwoldt MO, Freitag A, Rother LM, Schmitt A, Schnell O, Hense J, Misch M, Krex D, Stevanovic S, Tabatabai G, Steinbach JP, Bendszus M, von Deimling A, Schmitt M, Wick W. A vaccine targeting mutant IDH1 in newly diagnosed glioma. Nature. 2021 Apr;592(7854):463-468. doi: 10.1038/s41586-021-03363-z. Epub 2021 Mar 24.

Drugs

Indications