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

  • Clinicaltrials.gov identifier

    NCT04324840

  • Recruitment Status

    Recruiting

  • First Posted

    March 27, 2020

  • Last update posted

    May 5, 2022

Study Description

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:Glioblastoma
  • Intervention/Treatment: Drug: CC-90010
    Drug: Temozolomide
    Radiation: Radiotherapy
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 194 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma
  • Actual Study Start Date: July 2020
  • Estimated Primary Completion Date: August 2023
  • Estimated Study Completion Date: November 2024

Arms and interventions

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

Outcome Measures

  • 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

Eligibility Criteria

  • 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

Contacts and Locations

Contacts

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

Denmark
Aalborg Universitets hospital
Aalborg

Denmark
Rigshospitalet University Hospital
Copenhagen

Denmark
Odense University, Region South
Odense

Italy
Local Institution - 201
Milano

Italy
Ospedale San Raffaele
Milano

Italy
Istituto Clinico Humanitas
Milan

Italy
Local Institution - 202
Milan

Italy
Istituto Oncologico Veneto
Padova

Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona

Netherlands
The Netherlands Cancer Instiute Antoni Van Leeuwenhoekziekenhuis
Amsterdam

Netherlands
Leids Universitair Medisch Centrum
Leiden

Netherlands
Erasmus Universitair Medisch Centrum
Rotterdam

Netherlands
Local Institution - 401
Utrecht

Netherlands
University Medical Center Utrecht
Utrecht

Norway
Local Institution - 600
Oslo

Norway
Oslo University Hospital, Rikshospitalet HF
Oslo

Spain
Hospital del Mar
Barcelona

Spain
Hospital Val d´Hebron
Barcelona

Spain
Local Institution - 302
Barcelona

Spain
Hospital Clinic de Barcelona
Barcelona

Spain
Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO
Hospitalet de Llobregat, Barcelona

Spain
Hospital Ramon y Cajal
Madrid

Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid

Spain
Local Institution - 301
Madrid

Spain
Hospital Doce de Octubre
Madrid

Spain
Local Institution - 300
Madrid

Spain
Hospital Virgen del Rocio
Sevilla

Spain
Hospital Universitario La Fe
Valencia

Sweden
Sahlgrenska University Hospital
Goteborg

Sweden
Skanes Universitetssjukhus - Lund - Onkologiska Klinik
Lund

Sweden
Karolinska University Hospital Huddinge
Solna

Sweden
Uppsala University
Uppsala

Sponsors and Collaborators

Celgene

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT04324840 History of Changes
  • Other Study ID Numbers: CC-90010-GBM-002, U1111-1248-0496, 2019-004122-25
  • First Posted: March 27, 2020 Key Record Dates
  • Last Update Posted: May 5, 2022
  • Last Verified: May 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/
  • 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: Glioblastoma
    Astrocytoma
    Glioma
    Neoplasms, Neuroepithelial
    Neuroectodermal Tumors
    Neoplasms, Germ Cell and Embryonal
    Neoplasms by Histologic Type
    Neoplasms
    Neoplasms, Glandular and Epithelial
    Neoplasms, Nerve Tissue