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CC-90010 + Temozolomide for Glioblastoma

Phase 1
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky performance status of ≥70
Primary isocitrate dehydrogenase (IDH)-wild type newly diagnosed World Health Organization (WHO) Grade IV Glioblastoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trialtests the safety of a new drug for treating glioblastoma, a type of brain cancer, with/without radiotherapy.

Who is the study for?
This trial is for adults with a new diagnosis of Grade IV glioblastoma, confirmed to be IDH-wild type. Participants must have a Karnofsky performance status of ≥70, indicating they are able to care for themselves. They need known MGMT promoter methylation status and should not have had just a biopsy with less than 20% tumor resection or any metastatic extracranial disease.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of CC-90010 combined with standard treatment temozolomide (TMZ), with or without radiotherapy (RT), in treating newly diagnosed glioblastoma. The goal is to see how well patients tolerate this combination and its impact on their cancer.See study design
What are the potential side effects?
Potential side effects may include those typical of chemotherapy and radiation such as nausea, fatigue, hair loss, skin irritation at the radiation site, low blood cell counts leading to increased infection risk, headaches, and potential neurological symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself but may not be able to do active work.
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My brain tumor is a Grade IV Glioblastoma without IDH mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hazard ratio for PFS in Arm A vs Arm B
Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Incidence of dose-limiting toxicities (DLTs)
+6 more
Secondary outcome measures
Duration of therapy (DoT) in Arm A vs Arm B
Overall survival (OS) measured as the time from the first dose of CC-90010 to death due to any cause and will be analyzed in a manner similar to that described for PFS
Pharmacokinetics - Area under the plasma concentration time-curve (AUC)
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part B - Standard TMZ + RTExperimental Treatment1 Intervention
Control
Group II: Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)Experimental Treatment3 Interventions
Group III: Part AExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2610
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
642 Previous Clinical Trials
130,379 Total Patients Enrolled
10 Trials studying Glioblastoma
1,934 Patients Enrolled for Glioblastoma
Zariana Nikolova, MD, PhDStudy DirectorCelgene
5 Previous Clinical Trials
315 Total Patients Enrolled
1 Trials studying Glioblastoma
20 Patients Enrolled for Glioblastoma
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,519 Previous Clinical Trials
3,371,995 Total Patients Enrolled
8 Trials studying Glioblastoma
2,468 Patients Enrolled for Glioblastoma

Media Library

CC-90010 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04324840 — Phase 1
Glioblastoma Research Study Groups: Part A, Part B - Standard TMZ + RT, Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)
Glioblastoma Clinical Trial 2023: CC-90010 Highlights & Side Effects. Trial Name: NCT04324840 — Phase 1
CC-90010 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04324840 — Phase 1
~40 spots leftby May 2025
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