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

April 3, 2026 updated by: Bristol-Myers Squibb

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
          • Andre Schuh, Site 0002
          • Phone Number: 4168998644
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
          • Sarit Assouline, Site 0003
          • Phone Number: 5143408222x28434
  • France
      • Paris, France, 75010
        • Not yet recruiting
        • Local Institution - 0018
        • Contact:
          • Site 0018
      • Toulouse, France, 31100
        • Not yet recruiting
        • Local Institution - 0022
        • Contact:
          • Site 0022
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13273
        • Not yet recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
  • Spain
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
          • Eduardo Rodriguez, Site 0023
          • Phone Number: +34610098690
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
          • JORDI ESTEVE REYNER, Site 0020
          • Phone Number: +34932275400
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale-New Haven Hospital
        • Contact:
          • Amer Zeidan, Site 0011
          • Phone Number: 203-737-7078
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Contact:
          • Jessica Altman, Site 0010
          • Phone Number: 312-503-1794
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Rupa Narayan, Site 0014
          • Phone Number: 617-724-3456
      • Boston, Massachusetts, United States, 02114
        • Withdrawn
        • Local Institution - 0007
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Recruiting
        • Washington University School of Medicine, Siteman Cancer Center
        • Contact:
          • Geoffrey Uy, Site 0013
          • Phone Number: 314-273-1039
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center
        • Contact:
          • Jamie Koprivnikar, Site 0008
          • Phone Number: 551-996-3925
    • New York
      • New York, New York, United States, 10032
        • Withdrawn
        • Columbia University Irving Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
          • Abhishek Maiti, Site 0006
          • Phone Number: 832-696-8407
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Withdrawn
        • Local Institution - 0009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Acute Promyelocytic Leukemia.
  • Clinically active central nervous system leukemia.
  • Active malignant solid tumor.
  • Pregnant or breastfeeding.
  • Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Dose Escalation BMS-986497 (Monotherapy)
Drug: BMS-986497
Specified dose on specified days
Other Names:
  • ORM-6151
Experimental: Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy)
Drug: Azacitidine
Specified dose on specified days
Drug: BMS-986497
Specified dose on specified days
Other Names:
  • ORM-6151
Experimental: Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)
Drug: Venetoclax
Specified dose on specified days
Drug: Azacitidine
Specified dose on specified days
Drug: BMS-986497
Specified dose on specified days
Other Names:
  • ORM-6151

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose-limiting toxicities (DLTs)
Time Frame: Up to 21 days
Up to 21 days
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 2 years
Up to 2 years
Determine the Recommended Phase 2 Dose (RP2D) of BMS-986497 as Monotherapy
Time Frame: Up to 2 years
Up to 2 years
RP2D of BMS-986497 as Combination Therapy
Time Frame: Up to 2 years
The combination therapy included BMS-986497 and Azacitidine
Up to 2 years
RP2D of BMS-986497 as Triple Combination Therapy
Time Frame: Up to 2 years
The triple combination therapy included BMS-986497, Azacitidine and Venetoclax.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Event-free survival (EFS)
Time Frame: Up to 4 years
Up to 4 years
Maximum concentration (Cmax)
Time Frame: Up to 2 years
Up to 2 years
Time to reach Cmax (Tmax)
Time Frame: Up to 2 years
Up to 2 years
Area under the curve from time 0 to last quantifiable concentration (AUC0-last)
Time Frame: Up to 2 years
Up to 2 years
Overall response rate (ORR)
Time Frame: Up to 4 years
Up to 4 years
Duration of response (DoR)
Time Frame: Up to 4 years
Up to 4 years
Best overall response (BOR)
Time Frame: Up to 4 years
Up to 4 years
Complete remission (CR)
Time Frame: Up to 4 years
Up to 4 years
Complete remission with incomplete hematologic recovery (Cri)
Time Frame: Up to 4 years
Up to 4 years
Complete remission with partial hematologic recovery (CRh) rate
Time Frame: Up to 4 years
Up to 4 years
Transition rate to allogeneic hematopoietic stem cell transplantation (HSCT)
Time Frame: Up to 4 years
Up to 4 years
Incidence of Anti-drug antibody (ADA) against BMS-986497
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

September 16, 2030

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA235-0001
  • 2024-519537-29 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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