Study start expected in October 2018
Open-label, randomized, three-arm phase I study
The NOA-21 / AMPLIFY-NEOVAC study is comparing safety and efficacy of the mutation-specific IDH1 peptide vaccine from the NOA-16 trial in combination with checkpoint inhibition with avelumab to avelumab therapy alone and IDH1 peptide vaccine alone in patients with first recurrence of diffuse glioma with IDH1R132H mutation, without 1p/19q encoding or loss of ATRX expression and an indication for resection.
Patients initially receive 3 peptide vaccinations (arm 1), 3 peptide vaccinations together with 3 avelumab infusions (arm 2), or 3 avelumab infusions (arm 3) over a 6-week period before planned re-resection. Tumor tissue is extensively immunologically and molecularly classified. Postoperatively, immunotherapy of each treatment arm will be continued until tumor progression.