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

NCT ID: NCT06419634

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-29

Study Completion Date

2030-09-16

Brief Summary

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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

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Conditions

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Acute Myeloid Leukemia Myelodysplastic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Dose Escalation BMS-986497 (Monotherapy)

Group Type EXPERIMENTAL

BMS-986497

Intervention Type DRUG

Specified dose on specified days

Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy)

Group Type EXPERIMENTAL

BMS-986497

Intervention Type DRUG

Specified dose on specified days

Azacitidine

Intervention Type DRUG

Specified dose on specified days

Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)

Group Type EXPERIMENTAL

BMS-986497

Intervention Type DRUG

Specified dose on specified days

Azacitidine

Intervention Type DRUG

Specified dose on specified days

Venetoclax

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986497

Specified dose on specified days

Intervention Type DRUG

Azacitidine

Specified dose on specified days

Intervention Type DRUG

Venetoclax

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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ORM-6151

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status RECRUITING

Local Institution - 0007

Boston, Massachusetts, United States

Site Status WITHDRAWN

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Washington University School of Medicine, Siteman Cancer Center

St Louis, Missouri, United States

Site Status RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Columbia University Irving Medical Center

New York, New York, United States

Site Status WITHDRAWN

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Local Institution - 0009

Fairfax, Virginia, United States

Site Status WITHDRAWN

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Local Institution - 0017

Marseille, Bouches-du-Rhône, France

Site Status NOT_YET_RECRUITING

Local Institution - 0018

Paris, , France

Site Status NOT_YET_RECRUITING

Local Institution - 0022

Toulouse, , France

Site Status NOT_YET_RECRUITING

Local Institution - 0020

Barcelona, Catalunya [Cataluña], Spain

Site Status NOT_YET_RECRUITING

Countries

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United States Canada France Spain

Central Contacts

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BMS Study Connect Contact Center www.BMSStudyConnect.com

Role: CONTACT

855-907-3286

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

Role: CONTACT

Facility Contacts

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Amer Zeidan, Site 0011

Role: primary

203-737-7078

Jessica Altman, Site 0010

Role: primary

312-503-1794

Rupa Narayan, Site 0014

Role: primary

617-724-3456

Geoffrey Uy, Site 0013

Role: primary

314-273-1039

Jamie Koprivnikar, Site 0008

Role: primary

551-996-3925

Abhishek Maiti, Site 0006

Role: primary

832-696-8407

Andre Schuh, Site 0002

Role: primary

4168998644

Sarit Assouline, Site 0003

Role: primary

5143408222x28434

Site 0017

Role: primary

Site 0018

Role: primary

Site 0022

Role: primary

Site 0020

Role: primary

Related Links

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Other Identifiers

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2024-519537-29

Identifier Type: OTHER

Identifier Source: secondary_id

CA235-0001

Identifier Type: -

Identifier Source: org_study_id

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