AMPLIFYing NEOepitope-specific VACcine Responses in Progressive Diffuse Glioma
Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
The trial will address safety and tolerability of the combination of the IDH1R132H-specific
vaccine with checkpoint blockade and seeks to explore predictive biomarkers for response to
checkpoint blockade in post-treatment tumor tissue. The study will enroll 48 evaluable
patients (presumably, 60 in total) with IDH1R132H-mutated gliomas with an unfavorable
molecular profile (no 1p/19q co-deletion, nuclear ATRX- loss) progressive after radiotherapy
and alkylating chemotherapy eligible for re-resection. After diagnosis of recurrent disease
on imaging patients will be randomized assigned in a 1:1:2 ratio into three arms. Arm 1 (12
patients) will receive three IDH1R132H peptide vaccines alone in two week intervals. Arm 2
(12 patients) will receive three IDH1R132H peptide vaccines in combination with three doses
of Avelumab in two week intervals. Arm 3 (24 patients) will receive three doses of Avelumab
in two week intervals. After 6 weeks of treatment patients (Arms 1-3) will undergo planned
re-resection. Four weeks after the operation treatment will be resumed consisting of five
additional vaccines (Arm 1+2) in 4 week intervals, followed by maintenance vaccines until
progression in three months' intervals after a pause of 16 weeks. Avelumab will be
administered in monthly intervals in Arms 2 and 3 starting four weeks after the operation
until progression.
Key outcome parameters will be safety and immunogenicity (Arms 1 and 2) based on peripheral
and intratumoral immune analyses assessed 9 months after re-resection.