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

Celgene

Status and phase: Terminated; Phase 1

Conditions: Glioblastoma

Treatments: Drug: Temozolomide; Radiation: Radiotherapy; Drug: CC-90010

Study type: Interventional

Funder types: Industry

Identifiers

NCT04324840

CC-90010-GBM-002

2019-004122-25 (EudraCT Number)

U1111-1248-0496 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 3 patient groups

Part A

Experimental group

Treatment:

Drug: CC-90010

Radiation: Radiotherapy

Drug: Temozolomide

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

Experimental group

Treatment:

Drug: CC-90010

Radiation: Radiotherapy

Drug: Temozolomide

Part B - Standard TMZ + RT

Other group

Description:

Control

Treatment:

Radiation: Radiotherapy