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

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Celgene

Status and phase

Active, not recruiting
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

194 estimated 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)

194 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

Trial contacts and locations

29

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Data sourced from clinicaltrials.gov

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