NCT05168202
Recruiting
December 23, 2021
March 14, 2022
Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 alone and in combination with antineoplastic agents in participants with relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive higher risk melodysplastic syndromes.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: CC-95251 + azacitidine |
Drug: CC-95251 Specified dose on specified days Drug: Azacitidine Specified dose on specified days |
Experimental: CC-95251 monotherapy |
Drug: CC-95251 Specified dose on specified days |
Inclusion Criteria: • Eastern Cooperative Oncology Group Performance Status of 0 to 2 For Parts A & B: Relapsed or refractory (R/R) acute myeloid leukemia (AML) as defined by the 2016 WHO Classification R/R myelodysplastic syndromes (MDS) as defined by the 2016 WHO Classification with intermediate, high or very high risk by Revised International Prognostic Scoring System (IPSS-R) For Part C: • Treatment-naïve (ie, previously untreated) MDS as defined by the 2016 WHO Classification with intermediate, high or very high risk by IPSS-R Exclusion Criteria: Acute promyelocytic leukemia Immediately life-threatening, severe complications of leukemia such as disseminated/uncontrolled infection, uncontrolled bleeding, and/or uncontrolled disseminated intravascular coagulation Participants who have received prior treatment with a CD47 or SIRPα targeting agent Participant is on chronic systemic immunosuppressive therapy or corticosteroids Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting study treatment, whichever is shorter (relapsed or refractory participants only). Any condition including, active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study Pregnant or nursing participants. Other protocol-defined inclusion/exclusion criteria apply
Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com/ 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.
United States, California
Local Institution
Marina Del Rey
United States, California
Local Institution
Stanford
United States, Florida
Local Institution
Miami
United States, Illinois
Local Institution
Chicago
United States, New York
Local Institution
Buffalo
United States, Texas
Local Institution
Houston
United States, Washington
Local Institution
Seattle
Australia, New South Wales
Local Institution
Wollongong
Australia, Victoria
Local Institution
Clayton
Australia, Victoria
Local Institution
Fitzroy
Australia, Victoria
Local Institution
Heidelberg
Canada, Alberta
Local Institution
Edmonton
Canada, British Columbia
Local Institution
Vancouver
Canada, Ontario
Local Institution
Toronto
Canada, Quebec
Local Institution
Montreal
Denmark
Local Institution
Odense
France
Local Institution
Marseille
France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-hematology
Nantes
France
Local Institution
Pessac
France
Institut Claudius Regaud
Toulouse
France
Local Institution
Villejuif
Italy
Local Institution
Meldola
Italy
Local Institution
Milan
Italy
Local Institution
Rozzano
Norway
Local Institution
Bergen
Norway
Local Institution
Oslo
Spain
Local Institution
Badalona
Spain
Local Institution
Barcelona
Spain
Local Institution
Madrid
Spain
Local Institution
Salamanca
Spain
Local Institution
Santander
Sweden
Local Institution
Goteborg
Sweden
Local Institution
Huddinge
Sweden
Local Institution
Lund
United Kingdom
Local Institution
Edinburgh
United Kingdom
Local Institution
Oxford
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb