Clinical trial NCT04324840: A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma
Official title: A Phase 1b, Open-label, Dose-Finding Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Glioblastoma
Keywords: CC-90010
Temozolomide
Glioblastoma
NEWLY DIAGNOSED
Radiation therapy
Safety
Tolerability
MTD and RP2D
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2020-03-27
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
timeFrame: Up to 3 years
measure: Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0
timeFrame: Up to 3 years
measure: Incidence of dose-limiting toxicities (DLTs)
timeFrame: Up to 3 years
measure: Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ)
timeFrame: Up to 3 years
measure: MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT)
timeFrame: Up to 3 years
measure: Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ
timeFrame: Up to 3 years
measure: RP2D of CC-90010 in combination with TMZ and RT
timeFrame: Up to 3 years
measure: Median Progression-free survival (PFS) in Arm A vs Arm B
timeFrame: Up to 12 months
measure: Hazard ratio for PFS in Arm A vs Arm B
timeFrame: Up to 12 months
Secondary outcomes:
measure: 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
timeFrame: Up to 5 years
measure: 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
timeFrame: Up to 5 years
measure: Duration of therapy (DoT) in Arm A vs Arm B
timeFrame: Up to 5 years
measure: Response by Response Assessment in Neuro-Oncology (RANO) criteria
timeFrame: Up to 5 years
measure: Pharmacokinetics - Maximum observed plasma concentration (Cmax)
timeFrame: Up to 2 years
measure: Pharmacokinetics - Area under the plasma concentration time-curve (AUC)
timeFrame: Up to 2 years
measure: Pharmacokinetics - Time to maximum plasma concentration (Tmax)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Local Institution - 800
state: New York
city: Aalborg
country: Denmark
facility: Local Institution - 503
city: Copenhagen
country: Denmark
facility: Local Institution - 501
city: Odense
country: Denmark
facility: Local Institution - 500
city: Milano
country: Italy
facility: Local Institution - 201
city: Milan
country: Italy
facility: Local Institution - 202
city: Padova
country: Italy
facility: Local Institution - 204
city: Verona
country: Italy
facility: Local Institution - 200
city: Leiden
country: Netherlands
facility: Local Institution - 408
state: Zuid-Holland
city: Amsterdam
country: Netherlands
facility: Local Institution - 405
city: Rotterdam
country: Netherlands
facility: Local Institution - 400
city: Utrecht
country: Netherlands
facility: Local Institution - 401
city: Oslo
country: Norway
facility: Local Institution - 600
city: A Coruna
country: Spain
facility: Local Institution - 311
city: Barcelona
country: Spain
facility: Local Institution - 306
city: Barcelona
country: Spain
facility: Local Institution - 302
city: Barcelona
country: Spain
facility: Local Institution - 303
city: Hospitalet de Llobregat, Barcelona
country: Spain
facility: Local Institution - 307
city: Madrid
country: Spain
facility: Local Institution - 304
city: Madrid
country: Spain
facility: Local Institution - 301
city: Madrid
country: Spain
facility: Local Institution - 300
city: Pamplona
country: Spain
facility: Local Institution - 310
city: Sevilla
country: Spain
facility: Local Institution - 309
city: Valencia
country: Spain
facility: Local Institution - 305
city: Vigo
country: Spain
facility: Local Institution - 312
city: Goteborg
country: Sweden
facility: Local Institution - 702
city: Lund
country: Sweden
facility: Local Institution - 701
city: Solna
country: Sweden
facility: Local Institution - 700
city: Uppsala
country: Sweden
facility: Local Institution - 703
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: