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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04324840
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Celgene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Denmark, Italy, Netherlands, Norway, Spain, Sweden, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Part A

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

Other: Part B - Standard TMZ + RT

Control

Interventions

Drug: - CC-90010

Specified dose on specified days

Drug: - Temozolomide

Specified dose on specified days

Radiation: - Radiotherapy

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Local Institution - 800, New York, New York

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Local Institution - 800

New York, New York, 10075

International Sites

Local Institution - 503, Aalborg, Denmark

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Local Institution - 503

Aalborg, , 9100

Local Institution - 501, Copenhagen, Denmark

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Local Institution - 501

Copenhagen, , 2100

Local Institution - 500, Odense, Denmark

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Local Institution - 500

Odense, , 5000

Local Institution - 201, Milano, Italy

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Local Institution - 201

Milano, , 20132

Local Institution - 202, Milan, Italy

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Local Institution - 202

Milan, , 20089

Local Institution - 204, Padova, Italy

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Local Institution - 204

Padova, , 35128

Local Institution - 200, Verona, Italy

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Local Institution - 200

Verona, , 37126

Local Institution - 408, Leiden, Zuid-Holland, Netherlands

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Local Institution - 408

Leiden, Zuid-Holland, 2333 ZA

Local Institution - 405, Amsterdam, Netherlands

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Local Institution - 405

Amsterdam, , 1066 CX

Local Institution - 400, Rotterdam, Netherlands

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Local Institution - 400

Rotterdam, , 3015 GD

Local Institution - 401, Utrecht, Netherlands

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Local Institution - 401

Utrecht, , 3584 CX

Local Institution - 600, Oslo, Norway

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Local Institution - 600

Oslo, , 0424

Local Institution - 311, A Coruna, Spain

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Local Institution - 311

A Coruna, , 15006

Local Institution - 306, Barcelona, Spain

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Local Institution - 306

Barcelona, , 08003

Local Institution - 302, Barcelona, Spain

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Local Institution - 302

Barcelona, , 08035

Local Institution - 303, Barcelona, Spain

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Local Institution - 303

Barcelona, , 08036

Local Institution - 307, Hospitalet de Llobregat, Barcelona, Spain

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Local Institution - 307

Hospitalet de Llobregat, Barcelona, , 08907

Local Institution - 304, Madrid, Spain

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Local Institution - 304

Madrid, , 28034

Local Institution - 301, Madrid, Spain

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Local Institution - 301

Madrid, , 28040

Local Institution - 300, Madrid, Spain

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Local Institution - 300

Madrid, , 28041

Local Institution - 310, Pamplona, Spain

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Local Institution - 310

Pamplona, , 31008

Local Institution - 309, Sevilla, Spain

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Local Institution - 309

Sevilla, , 41013

Local Institution - 305, Valencia, Spain

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Local Institution - 305

Valencia, , 46026

Local Institution - 312, Vigo, Spain

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Local Institution - 312

Vigo, , 36312

Local Institution - 702, Goteborg, Sweden

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Local Institution - 702

Goteborg, , 413 45

Local Institution - 701, Lund, Sweden

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Local Institution - 701

Lund, , 222 41

Local Institution - 700, Solna, Sweden

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Local Institution - 700

Solna, , 171 64

Local Institution - 703, Uppsala, Sweden

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Local Institution - 703

Uppsala, , 75185