Targeting IDH1R132H in WHO grade III-IV IDH1R132H-mutated gliomas by a peptide vaccine – a phase I safety, tolerability and immunogenicity multicenter trial
Open-label, single-arm, phase I, first-in-man study
EudraCT Number: 2014-000503-27
Phase I: Enrollment completed in 30 evaluable patients. Data analysis pending.
The NOA-16 / Nonk-06 trial evaluates the safety and immunogenicity of a mutation-specific IDH1 peptide vaccine in combination with primary radiotherapy, primary chemotherapy with temozolomide, or primary combined radiochemotherapy with temozolomide in patients with grade III or grade IV gliomas with IDH1R132H mutation, without 1p/19q codeletion, and with loss of ATRX expression in a multicenter open-label phase I design. Patients will receive a total of 8 peptide vaccines over a 24-week period.