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Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sponsor: Bristol-Myers Squibb
Summary
The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 as a monotherapy, in double combination with Azacitidine and in triple combination with Azacitidine and Venetoclax in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Official title: Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double Combination With Azacitidine and in Triple Combination With Azacitidine and Venetoclax in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
105
Start Date
2024-05-29
Completion Date
2030-09-16
Last Updated
2026-04-08
Healthy Volunteers
No
Interventions
BMS-986497
Specified dose on specified days
Azacitidine
Specified dose on specified days
Venetoclax
Specified dose on specified days
Locations (16)
Yale-New Haven Hospital
New Haven, Connecticut, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Local Institution - 0007
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine, Siteman Cancer Center
St Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Columbia University Irving Medical Center
New York, New York, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Local Institution - 0009
Fairfax, Virginia, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Local Institution - 0017
Marseille, Bouches-du-Rhône, France
Local Institution - 0018
Paris, France
Local Institution - 0022
Toulouse, France
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain