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.
Adults, aged 18-75 years inclusive at the time of giving informed consent. Local laws will be followed if the age at consent is older.
Have a histologically confirmed diagnosis of WHO Grade IV GBM, IDH-wildtype consistent with WHO CNS 2021 criteria.
Have recurrent supratentorial GBM who have received prior treatment with at least radiotherapy and temozolomide.
Have first recurrence documented by magnetic resonance imaging (MRI), with an interval of at least 12 weeks after the end of prior radiotherapy unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field.
Any anticancer therapies, including systemic, palliative, biologic, immunostimulatory, or immunosuppressive treatment within 4 weeks (or five half-lives, whichever is longer) before starting the study treatment.
PD(L)-1/VEGF bispecific antibodies, cluster of differentiation (CD)137 agonists or other immune checkpoint blockade therapies including monotherapy with either category or combinations thereof.
Systemic corticosteroids (at a dosage greater than 2 mg/day of dexamethasone or an equivalent dose of other corticosteroids) within 7 days before starting the study treatment.
Vaccinations with live attenuated vaccine(s) within 4 weeks before starting the study treatment.
Parallel
Pumitamig
DrugIntravenous (IV) infusion
Bevacizumab
DrugIV infusion
Temozolomide
DrugOral
Confirmed overall response rate (ORR)
For Treatment Arms 1 and 2 only. Defined as the percentage of study participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (assessed by the blinded independent central review \[BICR\] per RANO 2.0) is observed as best overall response.
Occurrence of treatment emergent adverse events (TEAEs) by severity
According to (United States National Cancer Institute) Common Terminology Criteria for Adverse Events version 5.0 \[CTCAE v5.0\]). By relationship. For Treatment Arms 1 and 3 only.
Occurrence of dose interruptions, reductions or discontinuations of study treatment due to TEAEs
For Treatment Arms 1 and 3 only.
Confirmed ORR
Defined as the percentage of study participants in whom a confirmed CR or confirmed PR (assessed per RANO 2.0) is observed as best overall response. For Treatment Arms 1 and 2 assessment will be done by the investigator. For Treatment Arm 3, assessment will be done only by BICR.
Progression free survival (PFS)
For Treatment Arms 1 and 2 only. Defined as the time from randomization to first documented tumor progression (progressive disease assessed by BICR and investigator per RANO 2.0) or death from any cause, whichever occurs first.
PFS at 6 months
For Treatment Arms 1 and 2 only. Assessed by BICR and investigator per RANO 2.0.
Duration of response
For Treatment Arms 1 and 2 only. Defined as the time from first objective response (CR or PR as assessed by BICR and investigator per RANO 2.0) to first occurrence of objective tumor progression (progressive disease as assessed by BICR and investigator per RANO 2.0), or death from any cause, whichever occurs first.
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BioNTech SE
Lead sponsor
Bristol-Myers Squibb
Collaborator
BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Collaborator
