A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma
- Conditions
- Glioblastoma
- Interventions
- Registration Number
- NCT04324840
- Lead Sponsor
- Celgene
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 184
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT) Radiotherapy - Part B - Standard TMZ + RT Radiotherapy Control Part A Radiotherapy - Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT) CC-90010 - Part A CC-90010 - Part A Temozolomide - Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT) Temozolomide -
- Primary Outcome Measures
Name Time Method Incidence of dose-limiting toxicities (DLTs) Up to 3 years Part A
Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ) Up to 3 years Part A
MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT) Up to 3 years Part A
Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ Up to 3 years Part A
Median Progression-free survival (PFS) in Arm A vs Arm B Up to 12 months Part B
Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0 Up to 3 years Parts A and B
Hazard ratio for PFS in Arm A vs Arm B Up to 12 months Part B
Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Up to 3 years Parts A and B
RP2D of CC-90010 in combination with TMZ and RT Up to 3 years Part A
- Secondary Outcome Measures
Name Time Method Response by Response Assessment in Neuro-Oncology (RANO) criteria Up to 5 years Parts A and B
Pharmacokinetics - Time to maximum plasma concentration (Tmax) Up to 2 years Parts A and B
Progression-free survival (PFS) defined as the time from the first dose of CC-90010 to the first occurrence of disease progression or death from any cause Up to 5 years Parts A and B
Duration of therapy (DoT) in Arm A vs Arm B Up to 5 years Part B
Pharmacokinetics - Area under the plasma concentration time-curve (AUC) Up to 2 years Parts A and 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 Up to 5 years Parts A and B
Pharmacokinetics - Maximum observed plasma concentration (Cmax) Up to 2 years Parts A and B
Trial Locations
- Locations (29)
Local Institution - 400
🇳🇱Rotterdam, Netherlands
Local Institution - 600
🇳🇴Oslo, Norway
Local Institution - 408
🇳🇱Leiden, Zuid-Holland, Netherlands
Local Institution - 201
🇮🇹Milano, Italy
Local Institution - 800
🇺🇸New York, New York, United States
Local Institution - 503
🇩🇰Aalborg, Denmark
Local Institution - 202
🇮🇹Milan, Italy
Local Institution - 500
🇩🇰Odense, Denmark
Local Institution - 204
🇮🇹Padova, Italy
Local Institution - 501
🇩🇰Copenhagen, Denmark
Local Institution - 200
🇮🇹Verona, Italy
Local Institution - 405
🇳🇱Amsterdam, Netherlands
Local Institution - 302
🇪🇸Barcelona, Spain
Local Institution - 401
🇳🇱Utrecht, Netherlands
Local Institution - 311
🇪🇸A Coruna, Spain
Local Institution - 306
🇪🇸Barcelona, Spain
Local Institution - 310
🇪🇸Pamplona, Spain
Local Institution - 303
🇪🇸Barcelona, Spain
Local Institution - 307
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Local Institution - 304
🇪🇸Madrid, Spain
Local Institution - 300
🇪🇸Madrid, Spain
Local Institution - 305
🇪🇸Valencia, Spain
Local Institution - 309
🇪🇸Sevilla, Spain
Local Institution - 702
🇸🇪Goteborg, Sweden
Local Institution - 312
🇪🇸Vigo, Spain
Local Institution - 700
🇸🇪Solna, Sweden
Local Institution - 701
🇸🇪Lund, Sweden
Local Institution - 703
🇸🇪Uppsala, Sweden
Local Institution - 301
🇪🇸Madrid, Spain