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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Glioblastoma
• Intervention / Treatment: Drug: CC-90010; Drug: Temozolomide; Radiation: Radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 194
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9100
    • Local Institution - 503
  • Copenhagen, Denmark, 2100
    • Local Institution - 501
  • Odense, Denmark, 5000
    • Local Institution - 500
• Italy
  • Milan, Italy, 20089
    • Local Institution - 202
  • Milano, Italy, 20132
    • Local Institution - 201
  • Padova, Italy, 35128
    • Local Institution - 204
  • Verona, Italy, 37126
    • Local Institution - 200
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Local Institution - 405
  • Rotterdam, Netherlands, 3015 GD
    • Local Institution - 400
  • Utrecht, Netherlands, 3584 CX
    • Local Institution - 401
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Local Institution - 408
• Norway
  • Oslo, Norway, 0424
    • Local Institution - 600
• Spain
  • A Coruna, Spain, 15006
    • Local Institution - 311
  • Barcelona, Spain, 08035
    • Local Institution - 302
  • Barcelona, Spain, 08003
    • Local Institution - 306
  • Barcelona, Spain, 08036
    • Local Institution - 303
  • Hospitalet de Llobregat, Barcelona, Spain, 08907
    • Local Institution - 307
  • Madrid, Spain, 28034
    • Local Institution - 304
  • Madrid, Spain, 28040
    • Local Institution - 301
  • Madrid, Spain, 28041
    • Local Institution - 300
  • Pamplona, Spain, 31008
    • Local Institution - 310
  • Sevilla, Spain, 41013
    • Local Institution - 309
  • Valencia, Spain, 46026
    • Local Institution - 305
  • Vigo, Spain, 36312
    • Local Institution - 312
• Sweden
  • Goteborg, Sweden, 41345
    • Local Institution - 702
  • Lund, Sweden, 222 41
    • Local Institution - 701
  • Solna, Sweden, 171 64
    • Local Institution - 700
  • Uppsala, Sweden, 75185
    • Local Institution - 703
• United States
  • New York
    • New York, New York, United States, 10075
      • Local Institution - 800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A	Drug: CC-90010; Specified dose on specified days; Drug: Temozolomide; Specified dose on specified days; Radiation: Radiotherapy; Specified dose on specified days
Experimental: Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)	Drug: CC-90010; Specified dose on specified days; Drug: Temozolomide; Specified dose on specified days; Radiation: Radiotherapy; Specified dose on specified days
Other: Part B - Standard TMZ + RT; Control	Radiation: Radiotherapy; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0	Parts A and B	Up to 3 years
Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0	Parts A and B	Up to 3 years
Incidence of dose-limiting toxicities (DLTs)	Part A	Up to 3 years
Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ)	Part A	Up to 3 years
MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT)	Part A	Up to 3 years
Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ	Part A	Up to 3 years
RP2D of CC-90010 in combination with TMZ and RT	Part A	Up to 3 years
Median Progression-free survival (PFS) in Arm A vs Arm B	Part B	Up to 12 months
Hazard ratio for PFS in Arm A vs Arm B	Part B	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Up to 5 years
Duration of therapy (DoT) in Arm A vs Arm B	Part B	Up to 5 years
Response by Response Assessment in Neuro-Oncology (RANO) criteria	Parts A and B	Up to 5 years
Pharmacokinetics - Maximum observed plasma concentration (Cmax)	Parts A and B	Up to 2 years
Pharmacokinetics - Area under the plasma concentration time-curve (AUC)	Parts A and B	Up to 2 years
Pharmacokinetics - Time to maximum plasma concentration (Tmax)	Parts A and B	Up to 2 years

Collaborators and Investigators

• Sponsor: Celgene

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Anticipated): September 12, 2023
• Study Completion (Anticipated): March 5, 2025

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Temozolomide; Tolerability; Glioblastoma; Radiation therapy; CC-90010; NEWLY DIAGNOSED; MTD and RP2D
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: CC-90010-GBM-002; U1111-1248-0496 (Other Identifier: WHO); 2019-004122-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No