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
← catalyst calendarNCT06419634 · readout in 166 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
105estimated
Sites
16
Countries
Canada, France, Spain +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-05-29 | actual | When the study began enrolling |
| Primary completion | 2027-02-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-09-16 | estimated | The whole study's end, after follow-up |
| First posted | 2024-05-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
Interventions
- Drug: BMS-986497 — also filed as ORM-6151
- Drug: Azacitidine
- Drug: Venetoclax
Primary outcomes
what the primary-completion date above is the date OFIncidence of dose-limiting toxicities (DLTs)
measured Up to 21 days
Incidence of treatment-emergent adverse events (TEAEs)
measured Up to 2 years
Determine the Recommended Phase 2 Dose (RP2D) of BMS-986497 as Monotherapy
measured Up to 2 years
RP2D of BMS-986497 as Combination Therapy
measured Up to 2 years
RP2D of BMS-986497 as Triple Combination Therapy
measured Up to 2 years
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