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A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes |
Clinicaltrials.gov identifier | recruitment status | First Posted | Last update posted |
NCT05168202 | Recruiting | December 23, 2021 | March 14, 2022 |
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study description |
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. |
Condition or Disease: |
Leukemia, Myeloid, Acute Myelodysplastic Syndromes |
Intervention/treatment: |
Drug: CC-95251 Drug: Azacitidine |
Phase: | Phase 1 |
Detailed Description |
N/A |
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study design | ||||||||||||||||||||||
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Arms and interventions |
Arm | Intervention/treatment |
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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 |
outcome measures |
Primary Outcome Measures: |
1. Number of participants with a Dose-limiting toxicity (DLT) [ Time Frame: Up to 42 days ] |
2. Incidence of adverse events (AEs) [ Time Frame: Up to 56 days after the last dose of study treatment ] |
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Secondary Outcome Measures: |
1. Complete remission rate (CRR) for acute myeloid leukemia (AML) according to the modified European Leukemia Net (ELN) response criteria [ Time Frame: Up to 2 years after end of treatment ] |
2. Overall response rate (ORR) for AML [ Time Frame: Up to 2 years after end of treatment ] |
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3. CRR for myelodysplastic syndromes (MDS) according to the modified International Working Group (IWG) Response Criteria [ Time Frame: Up to 2 years after end of treatment ] |
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4. ORR for MDS [ Time Frame: Up to 2 years after end of treatment ] |
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5. Duration of remission [ Time Frame: Up to 2 years after end of treatment ] |
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6. Duration of response [ Time Frame: Up to 2 years after end of treatment ] |
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7. Stable disease rate is the rate of MDS participants whose best response is stable disease [ Time Frame: Up to 2 years after end of treatment ] |
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8. Relapse-free survival [ Time Frame: Up to 2 years after end of treatment ] |
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9. Event-free survival [ Time Frame: Up to 2 years after end of treatment ] |
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10. Progression-free survival [ Time Frame: Up to 2 years after end of treatment ] |
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11. Time to remission/response [ Time Frame: Up to 2 years after end of treatment ] |
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12. Transfusion independence [ Time Frame: Up to 2 years after end of treatment ] |
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13. Time to AML transformation for MDS participants [ Time Frame: Up to 2 years after end of treatment ] |
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14. Overall survival (OS) rates at 6 months [ Time Frame: Up to 2 years after end of treatment ] |
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15. OS rates at 12 months [ Time Frame: Up to 2 years after end of treatment ] |
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16. Maximum plasma concentration of drug (Cmax) [ Time Frame: Up to 8 weeks post-dose of CC-95251 ] |
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17. Minimum serum concentration (Cmin) [ Time Frame: Up to 8 weeks post-dose of CC-95251 ] |
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18. Trough observed serum concentration (Ctrough) [ Time Frame: Up to 8 weeks post-dose of CC-95251 ] |
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19. Presence of anti-CC-95251 antibodies (ADAs) using a validated electrochemiluminescence (ECL) assay [ Time Frame: Up to 8 weeks post-dose of CC-95251 ] |
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20. Frequency of ADAs using a validated ECL assay [ Time Frame: Up to 8 weeks post-dose of CC-95251 ] |
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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: • 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 |
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Contacts and Locations |
Contacts |
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 #. |
Locations |
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 |
Sponsors and Collaborators |
Bristol-Myers Squibb |
Investigator | ||
Study Director : | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information | ||||||||||||||||
Responsible Party : | Bristol-Myers Squibb | |||||||||||||||
ClinicalTrials.gov Identifier : | NCT05168202 | |||||||||||||||
Other Study ID Numbers : | CA059-001, 2021-002799-38 | |||||||||||||||
First Posted : | December 23, 2021 | |||||||||||||||
Last Update Posted : | March 14, 2022 | |||||||||||||||
Last Verified : | March 2022 | |||||||||||||||
Studies a U.S. FDA-regulated Drug Product: | Yes | |||||||||||||||
Studies a U.S. FDA-regulated Device Product: | No | |||||||||||||||
Keywords provided by Bristol-Myers Squibb: |
Myelodysplastic Syndromes Acute Myeloid Leukemia AML MDS Hematologic Cancers Leukemia Anti-SIRPa antibody CC-95251 |
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Additional relevant MeSH terms : |
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