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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04324840
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : November 24, 2022
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: CC-90010 Drug: Temozolomide Radiation: Radiotherapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 10, 2020
Estimated Primary Completion Date : September 12, 2023
Estimated Study Completion Date : March 5, 2025

Resource links provided by the National Library of Medicine


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

Part B - Standard TMZ + RT
Control
Radiation: Radiotherapy
Specified dose on specified days




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [ Time Frame: Up to 3 years ]
    Parts A and B

  2. Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0 [ Time Frame: Up to 3 years ]
    Parts A and B

  3. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 3 years ]
    Part A

  4. Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ) [ Time Frame: Up to 3 years ]
    Part A

  5. MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT) [ Time Frame: Up to 3 years ]
    Part A

  6. Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ [ Time Frame: Up to 3 years ]
    Part A

  7. RP2D of CC-90010 in combination with TMZ and RT [ Time Frame: Up to 3 years ]
    Part A

  8. Median Progression-free survival (PFS) in Arm A vs Arm B [ Time Frame: Up to 12 months ]
    Part B

  9. Hazard ratio for PFS in Arm A vs Arm B [ Time Frame: Up to 12 months ]
    Part B


Secondary Outcome Measures :
  1. 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 [ Time Frame: Up to 5 years ]
    Parts A and B

  2. 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 [ Time Frame: Up to 5 years ]
    Parts A and B

  3. Duration of therapy (DoT) in Arm A vs Arm B [ Time Frame: Up to 5 years ]
    Part B

  4. Response by Response Assessment in Neuro-Oncology (RANO) criteria [ Time Frame: Up to 5 years ]
    Parts A and B

  5. Pharmacokinetics - Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 2 years ]
    Parts A and B

  6. Pharmacokinetics - Area under the plasma concentration time-curve (AUC) [ Time Frame: Up to 2 years ]
    Parts A and B

  7. Pharmacokinetics - Time to maximum plasma concentration (Tmax) [ Time Frame: Up to 2 years ]
    Parts A and B



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324840


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
Show Show 54 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04324840    
Other Study ID Numbers: CC-90010-GBM-002
U1111-1248-0496 ( Other Identifier: WHO )
2019-004122-25 ( EudraCT Number )
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: November 24, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
CC-90010
Temozolomide
Glioblastoma
NEWLY DIAGNOSED
Radiation therapy
Safety
Tolerability
MTD and RP2D
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents