Back to Trials
NCT06419634PHASE1Recruiting

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

Bristol-Myers Squibb

Start Date

5/29/2024

Completion Date

9/16/2030

Summary

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BMS-986497

DRUG

Azacitidine

DRUG

Venetoclax

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Locations

Yale-New Haven Hospital

New Haven, Connecticut 06510

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611

United States

Local Institution - 0007

Boston, Massachusetts 02114

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Washington University School of Medicine, Siteman Cancer Center

St Louis, Missouri 63108

United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Columbia University Irving Medical Center

New York, New York 10032

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Local Institution - 0009

Fairfax, Virginia 22031

United States

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

Local Institution - 0017

Marseille, Bouches-du-Rhône 13273

France

Local Institution - 0018

Paris, 75010

France

Local Institution - 0022

Toulouse, 31100

France

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña] 08036

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain