This multi-site Phase II study will enroll adults with histologically confirmed diagnosis of World Health Organization (WHO) Grade IV glioblastoma (GBM), isocitrate dehydrogenase (IDH)-wildtype consistent with WHO central nervous system (CNS) 2021 criteria who have received prior first-line treatment including with at least radiotherapy and temozolomide, with a Karnofsky performance status (KPS) ≥60, adequate organ function, and at least one measurable lesion according to the response assessment in neuro-oncology (RANO) 2.0 criteria.
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Confirmed overall response rate (ORR)
Timeframe: Up to 24 months
Occurrence of treatment emergent adverse events (TEAEs) by severity
Timeframe: From the first dose of study treatment until 90 days after the last dose of study treatment (up to 27 months)
Occurrence of dose interruptions, reductions or discontinuations of study treatment due to TEAEs
Timeframe: Up to 24 months
BioNTech clinical trials patient information