A Phase 1b, Open-label, Dose-Finding Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma

Trial ID: NCT04324840

Interventional - Phase 1 - Terminated

The purpose of this study is to determine the safety and tolerability of CC-90010 when combined with standard of care treatment, temozolomide (TMZ) with or without radiotherapy (RT) in the newly diagnosed WHO Grade IV glioblastoma (ndGBM).

Conditions

• Glioblastoma

Interventions

• CC-90010
• Temozolomide
• Radiotherapy

Eligibility

Inclusion criteria

• Primary isocitrate dehydrogenase (IDH)-wild type newly diagnosed World Health Organization (WHO) Grade IV Glioblastoma
• O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status must be available prior to randomization
• Karnofsky performance status of ≥70

Exclusion criteria

• Indeterminate MGMT promoter methylation status
• Biopsy only of glioblastoma (GBM) at surgery, defined as \< 20% resection of enhancing tumor
• Any known metastatic extracranial or leptomeningeal disease
• Other protocol-defined inclusion/exclusion criteria apply

Sponsor

Celgene

Source: ClinicalTrials.gov

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