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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 800
New York, New York, United States
Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Parts A and B
Time frame: Up to 3 years
Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0
Parts A and B
Time frame: Up to 3 years
Incidence of dose-limiting toxicities (DLTs)
Part A
Time frame: Up to 3 years
Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ)
Part A
Time frame: Up to 3 years
MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT)
Part A
Time frame: Up to 3 years
Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ
Part A
Time frame: Up to 3 years
RP2D of CC-90010 in combination with TMZ and RT
Part A
Time frame: Up to 3 years
Median Progression-free survival (PFS) in Arm A vs Arm B
Part B
Time frame: Up to 12 months
Hazard ratio for PFS in Arm A vs Arm B
Part B
Time frame: Up to 12 months
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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
...and 19 more locations
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
Parts A and B
Time frame: Up to 5 years
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
Parts A and B
Time frame: Up to 5 years
Duration of therapy (DoT) in Arm A vs Arm B
Part B
Time frame: Up to 5 years
Response by Response Assessment in Neuro-Oncology (RANO) criteria
Parts A and B
Time frame: Up to 5 years
Pharmacokinetics - Maximum observed plasma concentration (Cmax)
Parts A and B
Time frame: Up to 2 years
Pharmacokinetics - Area under the plasma concentration time-curve (AUC)
Parts A and B
Time frame: Up to 2 years
Pharmacokinetics - Time to maximum plasma concentration (Tmax)
Parts A and B
Time frame: Up to 2 years