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

Stopped early · Phase 1

Conditions studied: Glioblastoma

In brief

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 facts

Study ID

NCT04324840

Run by

Celgene

People needed

184

Starts

2020-07-10

Expected to finish

2024-07-09

Last updated by the study team

2024-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 800 — New York, New York, United States
• Local Institution - 503 — Aalborg, Denmark
• Local Institution - 501 — Copenhagen, Denmark
• Local Institution - 500 — Odense, Denmark
• Local Institution - 202 — Milan, Italy
• Local Institution - 201 — Milan, Italy
• Local Institution - 204 — Padova, Italy
• Local Institution - 200 — Verona, Italy
• Local Institution - 408 — Leiden, South Holland, Netherlands
• Local Institution - 405 — Amsterdam, Netherlands
• Local Institution - 400 — Rotterdam, Netherlands
• Local Institution - 401 — Utrecht, Netherlands
• Local Institution - 600 — Oslo, Norway
• Local Institution - 311 — A Coruña, Spain
• Local Institution - 306 — Barcelona, Spain
• Local Institution - 302 — Barcelona, Spain
• Local Institution - 303 — Barcelona, Spain
• Local Institution - 307 — Hospitalet de Llobregat, Barcelona, Spain
• Local Institution - 304 — Madrid, Spain
• Local Institution - 301 — Madrid, Spain
• Local Institution - 300 — Madrid, Spain
• Local Institution - 310 — Pamplona, Spain
• Local Institution - 309 — Seville, Spain
• Local Institution - 305 — Valencia, Spain
• Local Institution - 312 — Vigo, Spain

Full record on ClinicalTrials.gov

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