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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

StatusTerminated
PhasePhase 1
Started2024-05-29
View on ClinicalTrials.gov ↗

Amendment history

2026-10-02
Trial terminated: Inability to meet protocol objectives
Final enrollment: 34 participants (planned 105)
Trial sites reduced: 16 → 10 locations
Primary completion confirmed: August 2026 (last estimated February 2027)
2026-04-03
Study Status, Contacts/Locations, IPDSharing v11
Study sites15→16
2025-10-29
Study Status, Contacts/Locations v10
Study sites15 entries, revised
LocalNorthwestern InstitutionMemorial - 0010Hospital
2025-06-30
Study Status, Contacts/Locations v9
Study sitescontacts updated at 1 of 15 sites
2025-06-04
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v8
Enrollment target35→105
Study sites11→15
Study arms2→3
InterventionsBMS-986497 (Drug)→Azacitidine (Drug), BMS-986497 (Drug), Venetoclax (Drug)
Primary endpoints3 to 5 entries
Determine the Recommended Phase 2 Dose (RP2D) of BMS-986497 as Monotherapy RP2D of BMS-986497 as Combination Therapy RP2D of BMS-986497 as Triple Combination Therapy
Study title+83 characters
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
Show 7 earlier versions
2025-04-11
Study Status, Contacts/Locations v7
Study sites11 entries, revised
LocalPrincess InstitutionMargaret -Cancer 0002Centre
2025-03-21
Study Status, Contacts/Locations, References v6
Study sites11 entries, revised
JohnOncology TheurerClinical CancerResearch CenterReferral at Hackensack University Medical CenterOffice
2024-12-20
Study Status, Contacts/Locations, References v5
Study sitesdetails revised at 1 of 11 sites
2024-11-13
Study Status, Contacts/Locations v4
Study sites11 entries, revised
LocalMassachusetts InstitutionGeneral - 0014Hospital
2024-10-15
Study Status, Contacts/Locations v3
Study sites11 entries, revised
LocalWashington InstitutionUniversity -School 0013of Medicine, Siteman Cancer Center
2024-08-29
Study Status, Contacts/Locations, References v2
Study sites11 entries, revised
LocalJohn InstitutionTheurer -Cancer 0008Center at Hackensack University Medical Center LocalUniversity Institutionof -Texas 0006MD Anderson Cancer Center
2024-06-26
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-05-30→confirmed 2024-05-29
Study sites11 entries, revised
LocalYale-New InstitutionHaven -Hospital Jewish 0011 LocalGeneral Institution - 0003Hospital
2024-05-14
Original filing
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).
Trial Details
NCT Number NCT06419634
Lead Sponsor Bristol-Myers Squibb
Conditions Acute Myeloid Leukemia, Myelodysplastic Syndrome
Enrollment 34 participants
Start Date 2024-05-29
Primary Completion 2026-08-28 (estimated)
Study Completion 2026-08-28 (estimated)
Updated on ClinicalTrials.gov 2026-10-01