Oncologie: Glioblastoma Glioblastoma hersentumor
Conditions
Interventions
The IMPs for this study are RO7428731, obinutuzumab, and tocilizumab.
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Aged >=18 years - Life expectancy of >= 12 weeks, in the opinion of the Investigator - Diagnosis of GBM based on on world health organization (WHO) classification of central nervous system (CNS) tumors, 5th edition - Confirmed Epidermal growth factor receptor variant III (EGFRvIII) - expression by a College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) certified central laboratory, in an archival tumor tissue sample using an investigational EGFRvIII immunohistochemistry (IHC) assay - Karnofsky Performance Status (KPS) Score of >=70% - Adequate organ functions within 7 days prior to start of study treatment - Coagulation activity: International Normalized Ratio =10 mm X >=10 mm
Exclusion criteria
Exclusion criteria: - Participants with infratentorial tumors and tumors primarily located in or close to critical structures - Presence of extracranial metastatic or leptomeningeal disease - Known hypersensitivity to immunoglobulins or to any other component of the investigational medicinal product (IMP) formulation - Therapy with any other investigational drug within 28 days or 5 half-lives of the drug before the first day of study treatment - Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment - Administration of a live, attenuated vaccine within 28 days before first day of study treatment or anticipation that such a live attenuated vaccine will be required during the study - Acute treatment-related toxicities from prior anti-cancer therapy that have not resolved to Grade
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - to evaluate the safety and tolerability profile of RO7428731 as monotherapy and, if applicable, with obinutuzumab pretreatment. - to determine the maximum tolerated dose (MTD) of RO7428731 monotherapy and, if applicable, with obinutuzumab pretreatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To characterize the PK profile of RO7428731 monotherapy and, if applicable, with obinutuzumab pretreatment in blood serum. - To evaluate the anti-RO7428731 immune response after treatment with RO7428731 monotherapy and, if applicable, with obinutuzumab pretreatment - To evaluate the effect of an anti-RO7428731 immune response after treatment with RO7428731 monotherapy and, if applicable, with obinutuzumab pretreatment - To assess preliminary anti-tumor activity of RO7428731 monotherapy and, if applicable, with obinutuzumab pretreatment - To determine the recommended dose for expansion (RDE)/recommended Phase 2 dose (RP2D) and treatment schedule of RO7428731 monotherapy and, if applicable, with obinutuzumab pretreatment | — |
Countries
Netherlands
Outcome results
None listed