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

ClinicalTrials.gov ID: NCT06419634

Public ClinicalTrials.gov record NCT06419634. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 22, 2026, 6:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT06419634
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Bristol-Myers Squibb; Industry
Enrollment: 105 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 28, 2024
Primary completion: Jan 31, 2027
Completion: Sep 15, 2030
Last update posted: Apr 7, 2026

2024 – 2030

United States locations

U.S. sites: 9
U.S. states: 8
U.S. cities: 8

Facility	City	State	ZIP	Site status
Yale-New Haven Hospital	New Haven	Connecticut	06510	Recruiting
Northwestern Memorial Hospital	Chicago	Illinois	60611	Recruiting
Local Institution - 0007	Boston	Massachusetts	02114	Withdrawn
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
Washington University School of Medicine, Siteman Cancer Center	St Louis	Missouri	63108	Recruiting
John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey	07601	Recruiting
Columbia University Irving Medical Center	New York	New York	10032	Withdrawn
University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
Local Institution - 0009	Fairfax	Virginia	22031	Withdrawn

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06419634, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 7, 2026 · Synced Sep 22, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06419634 live on ClinicalTrials.gov.

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