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

July 25, 2024 updated by: Celgene

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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, 413 45
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Up to 3 years
Parts A and B
Up to 3 years
Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0
Time Frame: Up to 3 years
Parts A and B
Up to 3 years
Incidence of dose-limiting toxicities (DLTs)
Time Frame: Up to 3 years
Part A
Up to 3 years
Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ)
Time Frame: Up to 3 years
Part A
Up to 3 years
MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT)
Time Frame: Up to 3 years
Part A
Up to 3 years
Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ
Time Frame: Up to 3 years
Part A
Up to 3 years
RP2D of CC-90010 in combination with TMZ and RT
Time Frame: Up to 3 years
Part A
Up to 3 years
Median Progression-free survival (PFS) in Arm A vs Arm B
Time Frame: Up to 12 months
Part B
Up to 12 months
Hazard ratio for PFS in Arm A vs Arm B
Time Frame: Up to 12 months
Part B
Up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
Parts A and B
Up to 5 years
Duration of therapy (DoT) in Arm A vs Arm B
Time Frame: Up to 5 years
Part B
Up to 5 years
Response by Response Assessment in Neuro-Oncology (RANO) criteria
Time Frame: Up to 5 years
Parts A and B
Up to 5 years
Pharmacokinetics - Maximum observed plasma concentration (Cmax)
Time Frame: Up to 2 years
Parts A and B
Up to 2 years
Pharmacokinetics - Area under the plasma concentration time-curve (AUC)
Time Frame: Up to 2 years
Parts A and B
Up to 2 years
Pharmacokinetics - Time to maximum plasma concentration (Tmax)
Time Frame: Up to 2 years
Parts A and B
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 9, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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