Active, Not Recruiting

Trial ID CC-90010-GBM-002 | NCT04324840

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

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

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About This Trial
Key Eligibility Criteria

Summary

Phase 1
18+

Age Range
Active, Not Recruiting

Overview

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).

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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Part A

ASSIGNED INTERVENTION

Drug: CC-90010, Temozolomide
Radiation: Radiotherapy

Study Arms

Experimental: Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)

ASSIGNED INTERVENTION

Drug: CC-90010, Temozolomide
Radiation: Radiotherapy

Study Arms

Other: Part B - Standard TMZ + RT

ASSIGNED INTERVENTION

Radiation: Radiotherapy