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

NCT04324840 | Terminated Phase 1

• 3 other identifiers: CC-90010-GBM-002U1111-1248-04962019-004122-25
• Study Type: interventional
• Target: 184
• Locations: 7 countries
• Sites: 29

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).

Conditions

Glioblastoma

Keywords

CC-90010; Temozolomide; Glioblastoma; NEWLY DIAGNOSED; Radiation therapy; Safety; Tolerability; MTD and RP2D

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (7)

• 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

• 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

• Duration of therapy (DoT) in Arm A vs Arm B

  Up to 5 years

• Response by Response Assessment in Neuro-Oncology (RANO) criteria

  Up to 5 years

• Pharmacokinetics - Maximum observed plasma concentration (Cmax)

  Up to 2 years

Study Arms (3)

Part A

EXPERIMENTAL

Drug: CC-90010; Drug: Temozolomide; Radiation: Radiotherapy

Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)

EXPERIMENTAL

Drug: CC-90010; Drug: Temozolomide; Radiation: Radiotherapy

Part B - Standard TMZ + RT

OTHER

Control

Radiation: Radiotherapy

Interventions

CC-90010 DRUG

Specified dose on specified days

Part A; Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)

Temozolomide DRUG

Specified dose on specified days

Part A; Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)

Radiotherapy RADIATION

Specified dose on specified days

Part A; Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT); Part B - Standard TMZ + RT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (29)

Local Institution - 800

New York, New York, 10075, United States

Location

Local Institution - 503

Aalborg, 9100, Denmark

Location

Local Institution - 501

Copenhagen, 2100, Denmark

Location

Local Institution - 500

Odense, 5000, Denmark

Location

Local Institution - 202

Milan, 20089, Italy

Location

Local Institution - 201

Milan, 20132, Italy

Location

Local Institution - 204

Padua, 35128, Italy

Location

Local Institution - 200

Verona, 37126, Italy

Location

Local Institution - 408

Leiden, South Holland, 2333 ZA, Netherlands

Location

Local Institution - 405

Amsterdam, 1066 CX, Netherlands

Location

Local Institution - 400

Rotterdam, 3015 GD, Netherlands

Location

Local Institution - 401

Utrecht, 3584 CX, Netherlands

Location

Local Institution - 600

Oslo, 0424, Norway

Location

Local Institution - 311

A Coruña, 15006, Spain

Location

Local Institution - 306

Barcelona, 08003, Spain

Location

Local Institution - 302

Barcelona, 08035, Spain

Location

Local Institution - 303

Barcelona, 08036, Spain

Location

Local Institution - 307

Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Local Institution - 304

Madrid, 28034, Spain

Location

Local Institution - 301

Madrid, 28040, Spain

Location

Local Institution - 300

Madrid, 28041, Spain

Location

Local Institution - 310

Pamplona, 31008, Spain

Location

Local Institution - 309

Seville, 41013, Spain

Location

Local Institution - 305

Valencia, 46026, Spain

Location

Local Institution - 312

Vigo, 36312, Spain

Location

Local Institution - 702

Gothenburg, 413 45, Sweden

Location

Local Institution - 701

Lund, 222 41, Sweden

Location

Local Institution - 700

Solna, 171 64, Sweden

Location

Local Institution - 703

Uppsala, 75185, Sweden

Location

Related Publications (1)

• Moreno V, Manuel Sepulveda J, Reardon DA, Perez-Nunez A, Gonzalez Leon P, Hanna B, Filvaroff E, Aronchik I, Chang H, Amoroso B, Zuraek M, Sanchez-Perez T, Mendez C, Stephens D, Nikolova Z, Vogelbaum MA. Trotabresib, an oral potent bromodomain and extraterminal inhibitor, in patients with high-grade gliomas: A phase I, "window-of-opportunity" study. Neuro Oncol. 2023 Jun 2;25(6):1113-1122. doi: 10.1093/neuonc/noac263.

  PMID: 36455228 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Glioblastoma; Metatropic dwarfism

Interventions

Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: July 10, 2020
• Primary Completion: July 9, 2024
• Study Completion: July 9, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

ES (12); SE (4); IT (4); DK (3); NO (1); US (1); NL (4)