A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
- Conditions
- Myelodysplastic SyndromesLeukemia, Myeloid, Acute
- Interventions
- Registration Number
- NCT05168202
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 218
• 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 (TN) (ie, previously untreated) MDS as defined by the 2016 WHO Classification with intermediate, high or very high risk by IPSS-R
For Part D:
• TN AML as defined by the 2016 WHO Classification, including secondary AML and therapy-related AML in participants who are ineligible (IE) for intensive chemotherapy (IC) and allogeneic hematopoietic stem cell transplant (HSCT)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CC-95251 + azacitidine Azacitidine - CC-95251 + azacitidine + venetoclax Venetoclax - CC-95251 monotherapy CC-95251 - CC-95251 + azacitidine CC-95251 -
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs) Up to 56 days after the last dose of study treatment Number of participants with a Dose-limiting toxicity (DLT) Up to 42 days
- Secondary Outcome Measures
Name Time Method ORR for MDS Up to 2 years after end of treatment Duration of remission Up to 2 years after end of treatment Duration of response Up to 2 years after end of treatment Complete remission rate (CRR) for acute myeloid leukemia (AML) according to the modified European Leukemia Net (ELN) response criteria Up to 2 years after end of treatment CRR for myelodysplastic syndromes (MDS) according to the modified International Working Group (IWG) Response Criteria Up to 2 years after end of treatment Stable disease rate is the rate of MDS participants whose best response is stable disease Up to 2 years after end of treatment Overall response rate (ORR) for AML Up to 2 years after end of treatment Relapse-free survival Up to 2 years after end of treatment Time to remission/response Up to 2 years after end of treatment Time to AML transformation for MDS participants Up to 2 years after end of treatment OS rates at 12 months Up to 2 years after end of treatment Maximum plasma concentration of drug (Cmax) Up to 8 weeks post-dose of CC-95251 Event-free survival Up to 2 years after end of treatment Progression-free survival Up to 2 years after end of treatment Transfusion independence Up to 2 years after end of treatment Overall survival (OS) rates at 6 months Up to 2 years after end of treatment Minimum serum concentration (Cmin) Up to 8 weeks post-dose of CC-95251 Trough observed serum concentration (Ctrough) Up to 8 weeks post-dose of CC-95251 Frequency of ADAs using a validated ECL assay Up to 8 weeks post-dose of CC-95251 Presence of anti-CC-95251 antibodies (ADAs) using a validated electrochemiluminescence (ECL) assay Up to 8 weeks post-dose of CC-95251
Trial Locations
- Locations (32)
Local Institution - 0001
🇺🇸Houston, Texas, United States
Local Institution - 0027
🇦🇺Wollongong, New South Wales, Australia
Local Institution - 0006
🇦🇺Clayton, Victoria, Australia
Local Institution - 0005
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 0037
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0019
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0011
🇨🇦Vancouver, British Columbia, Canada
Local Institution - 0010
🇨🇦Toronto, Ontario, Canada
Local Institution - 0038
🇨🇦Montreal, Quebec, Canada
Local Institution - 0040
🇫🇷Marseille, France
Local Institution - 0029
🇫🇷Nantes, France
Local Institution - 0020
🇫🇷Pessac, France
Local Institution - 0023
🇫🇷Toulouse, France
Local Institution - 0041
🇫🇷Villejuif, France
Local Institution - 0018
🇮🇹Meldola, Emilia-Romagna, Italy
Local Institution - 0026
🇮🇹Milan, Italy
Local Institution - 0017
🇮🇹Rozzano, Italy
Local Institution - 0025
🇳🇴Bergen, Norway
Local Institution - 0013
🇳🇴Oslo, Norway
Local Institution - 0030
🇺🇸Los Angeles, California, United States
Local Institution - 0031
🇺🇸Palo Alto, California, United States
Local Institution - 0047
🇺🇸Miami, Florida, United States
Local Institution - 0032
🇪🇸Badalona, Barcelona [Barcelona], Spain
Local Institution - 0039
🇪🇸Barcelona, Spain
Local Institution - 0036
🇪🇸Madrid, Spain
Local Institution - 0035
🇪🇸Salamanca, Spain
Local Institution - 0028
🇪🇸Santander, Spain
Local Institution - 0021
🇸🇪Gothenburg, Sweden
Local Institution - 0015
🇸🇪Lund, Sweden
Local Institution - 0014
🇸🇪Stockholm, Sweden
Local Institution - 0044
🇬🇧Edinburgh, Midlothian, United Kingdom
Local Institution - 0050
🇬🇧Oxford, Oxfordshire, United Kingdom