NCT04324840
Recruiting
March 27, 2020
May 5, 2022
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).
N/A
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 |
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
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 #.
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
Celgene
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb