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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06419634
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-986497 — DRUG
    Specified dose on specified days
  • Azacitidine — DRUG
    Specified dose on specified days
  • Venetoclax — DRUG
    Specified dose on specified days

Study Details

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).

Key Dates

Start date
May 29, 2024
Status verified
Apr 2026
Primary completion
Feb 1, 2027
Completion
Sep 16, 2030

Study Design

Enrollment
105 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation BMS-986497 (Monotherapy)
  • Experimental: Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy)
  • Experimental: Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 21 days ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (9)

FacilityCityStateZIPSite coordinators
Yale-New Haven HospitalNew HavenConnecticut06510
Amer Zeidan, Site 0011
203-737-7078
Northwestern Memorial HospitalChicagoIllinois60611
Jessica Altman, Site 0010
312-503-1794
Local Institution - 0007BostonMassachusetts02114-
Massachusetts General HospitalBostonMassachusetts02114
Rupa Narayan, Site 0014
617-724-3456
Washington University School of Medicine, Siteman Cancer CenterSt LouisMissouri63108
Geoffrey Uy, Site 0013
314-273-1039
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601
Jamie Koprivnikar, Site 0008
551-996-3925
Columbia University Irving Medical CenterNew YorkNew York10032-
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Abhishek Maiti, Site 0006
832-696-8407
Local Institution - 0009FairfaxVirginia22031-

Find similar trials in New Haven, CT

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Yale-New Haven Hospital· New Haven, CTNorthwestern Memorial Hospital· Chicago, ILLocal Institution - 0007· Boston, MAMassachusetts General Hospital· Boston, MAWashington University School of Medicine, Siteman Cancer Center· St Louis, MOJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJ

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