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  • NCT04324840

Active, Not Recruiting

A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma - CC-90010-GBM-002

Updated: 2 May, 2023   |   ClinicalTrials.gov

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

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Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part A
Drug: CC-90010, Temozolomide Radiation: Radiotherapy
Experimental: Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)
Drug: CC-90010, Temozolomide Radiation: Radiotherapy
Other: Part B - Standard TMZ + RT
Radiation: Radiotherapy

Key Eligibility Criteria

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

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Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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