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
- Conditions
- Acute Myeloid LeukemiaMyelodysplastic Syndrome
- Interventions
- Registration Number
- NCT06419634
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 105
- Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
- Detectable levels of cluster of differentiation 33 (CD33) expression.
- Failed alternative therapies with established benefit.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and adequate organ function.
- Acute Promyelocytic Leukemia.
- Clinically active central nervous system leukemia.
- Active malignant solid tumor.
- Pregnant or breastfeeding.
- Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Dose Escalation BMS-986497 (Monotherapy) BMS-986497 - Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy) BMS-986497 - Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy) Azacitidine - Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy) BMS-986497 - Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy) Azacitidine - Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy) Venetoclax -
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) Up to 2 years Determine the Recommended Phase 2 Dose (RP2D) of BMS-986497 as Monotherapy Up to 2 years RP2D of BMS-986497 as Combination Therapy Up to 2 years The combination therapy included BMS-986497 and Azacitidine
RP2D of BMS-986497 as Triple Combination Therapy Up to 2 years The triple combination therapy included BMS-986497, Azacitidine and Venetoclax.
Incidence of dose-limiting toxicities (DLTs) Up to 21 days
- Secondary Outcome Measures
Name Time Method Best overall response (BOR) Up to 4 years Complete remission (CR) Up to 4 years Time to reach Cmax (Tmax) Up to 2 years Area under the curve from time 0 to last quantifiable concentration (AUC0-last) Up to 2 years Complete remission with incomplete hematologic recovery (Cri) Up to 4 years Event-free survival (EFS) Up to 4 years Transition rate to allogeneic hematopoietic stem cell transplantation (HSCT) Up to 4 years Maximum concentration (Cmax) Up to 2 years Overall response rate (ORR) Up to 4 years Duration of response (DoR) Up to 4 years Complete remission with partial hematologic recovery (CRh) rate Up to 4 years Incidence of Anti-drug antibody (ADA) against BMS-986497 Up to 2 years
Related Research Topics
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Trial Locations
- Locations (15)
Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Local Institution - 0010
🇺🇸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
🇺🇸Saint 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
Scroll for more (5 remaining)Yale-New Haven Hospital🇺🇸New Haven, Connecticut, United StatesAmer Zeidan, Site 0011Contact203-737-7078