Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Life expectancy of greater than or equal to 12 weeks, in the opinion of the Investigator
Diagnosis of GBM based on World Health Organization (WHO) classification of central nervous system (CNS) tumors, 5th edition
Participants must have confirmed EGFRvIII-expression
Karnofsky Performance Status (KPS) Score of \>=70%
Adequate organ functions prior to start of study treatment
Willingness to abide by contraceptive measures for the duration of the study.
Participants whose tumors have an unmethylated (Part I and Part II) or methylated (Part I only) O6-methylguanine-DNA methyltransferase (MGMT) promotor status based on local assessment
Participants (in Part I): Adult participants with newly diagnosed EGFRvIII-positive GBM with unmethylated MGMT promotor status who have completed standard of care therapy with surgical resection and adjuvant radiotherapy with or without concomitant temozolomide. Participants are allowed to have received any number of cycles of temozolomide maintenance. Adult participants with newly diagnosed EGFRvIII-positive GBM with methylated MGMT promotor status who have completed standard of care with surgical resection and adjuvant radiotherapy with concomitant and maintenance temozolomide or discontinued temozolomide maintenance due to reasons other than progressive disease.
Participants (in Part II): Adult participants with newly diagnosed EGFRvIII-positive GBM with unmethylated MGMT promotor status who have completed standard of care therapy with surgical resection and adjuvant radiotherapy with or without concomitant temozolomide.
Documented first or second recurrence of GBM
At least one measurable GBM lesion as per Response Assessment in Neuro-Oncology (RANO) criteria prior to initiation of study treatment.
You may not be if
Participants with infratentorial tumors and tumors primarily located in or close to critical structures (e.g., brain stem)
Presence of extracranial metastatic or leptomeningeal disease
Known hypersensitivity to immunoglobulins or to any other component of the investigational medicinal product formulation
Active bleeding or pathological condition that carries a high risk of bleeding, including inherited and acquired coagulopathies
Participants unable to undergo an MRI with contrast.
Recurrent malignant gliomas
Any prior anti-tumor treatment for GBM: tumor resection, adjuvant radiotherapy with or without concomitant temozolomide and temozolomide maintenance (Part I only) must be the only tumor-directed treatment that the participant has received for GBM.
More than two recurrences of GBM
Prior anti-EGFRvIII-targeting agents (including vaccines), anti-angiogenic therapy, and/or gene therapy for the treatment of GBM and gliomas.
