A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas

April 8, 2024 updated by: Bristol-Myers Squibb

A Phase 1, Multi-Center, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BMS-986458, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed/Refractory Non-Hodgkin Lymphomas (R/R NHL)

The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458 as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

273

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 the NCT# and Site#

Study Contact Backup

Study Locations

  • France
      • Montpellier, France, 34295
        • Recruiting
        • CHU SAINT ELOI-Département d'Hématologie Clinique
        • Contact:
          • Guillaume Cartron, Site 0005
          • Phone Number: +33675926918
      • Toulouse, France, 31059
        • Recruiting
        • Institut Claudius Regaud
        • Contact:
          • Loïc Ysebaert, Site 0002
          • Phone Number: 33531156351
    • Nord
      • Lille, Nord, France, 59000
        • Recruiting
        • Hopital Claude Huriez - CHU de Lille
        • Contact:
          • Franck Morschhauser, Site 0003
          • Phone Number: 33320445713
    • Paris
      • Villejuif, Paris, France, 94800
        • Recruiting
        • Gustave Roussy
        • Contact:
          • Vincent Ribrag, Site 0001
          • Phone Number: 33142114507
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Not yet recruiting
        • Local Institution - 0053
        • Contact:
          • Site 0053
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Recruiting
        • Maastricht UMC+
        • Contact:
          • Marjolein Van der Poel, Site 0052
          • Phone Number: +31433877026
  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Contact:
          • Raul Cordoba Mascuñano, Site 0006
          • Phone Number: +34649694829
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
        • Contact:
          • Alejandro Martin García-Sancho, Site 0019
          • Phone Number: 34923291100
    • Andalucía
      • Málaga, Andalucía, Spain, 29010
        • Not yet recruiting
        • Local Institution - 0007
        • Contact:
          • Site 0007
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Miguel Canales Albendea, Site 0018
          • Phone Number: 34 948 396 297
  • Switzerland
      • Genève, Switzerland, 1211
        • Recruiting
        • Hôpitaux Universitaire de Genève
        • Contact:
          • Noemie Lang, Site 0048
          • Phone Number: +41795532406
    • Ticino
      • Bellinzona, Ticino, Switzerland, 6500
        • Recruiting
        • Ospedale Regionale Bellinzona e Valli
        • Contact:
          • Anastasios Stathis, Site 0033
          • Phone Number: 41918118931
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
          • Avyakta Kallam, Site 0020
          • Phone Number: 626-219-9200
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Philippe Armand, Site 0044
          • Phone Number: 617-632-2305
    • New York
      • Lake Success, New York, United States, 11042
        • Not yet recruiting
        • Local Institution - 0047
        • Contact:
          • Site 0047
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Jennifer Lue, Site 0046
          • Phone Number: 917-887-8514

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:

  • Participants ≥ 18 years of age with R/R NHL (including DLBCL [ie, DLBCL not otherwise specified (NOS) and diffuse large B-Cell lymphoma/high-grade B-Cell lymphoma with MYC and BCL2 rearrangements], and FL):

    • For R/R DLBCL (de novo) and FL 3b: following at least 2 prior lines of therapy (eg, first-line combination chemotherapy regimen containing rituximab, anthracycline, an alkylating agent, and steroids and at least one additional treatment).
    • For R/R DLBCL (transformed lymphoma): following at least 2 prior lines of therapy which must have been administered after transformation.
    • For R/R FL (except for FL 3b): following at least 2 prior lines of therapy and meeting treatment criteria at the time of enrollment based on investigator´s assessment.
  • Participant must have measurable disease (defined by at least one FDG-avid lesion for FDG-avid disease and one bi-dimensionally measurable disease on cross sectional imaging by computed tomography or magnetic resonance imaging with at least one lesion > 1.5 cm in the transverse diameter).
  • Participants must accept and follow pregnancy prevention plan.

Exclusion Criteria:

  • Participants must not have an Eastern Cooperative Oncology Group (ECOG)22 performance status ≥ 3.
  • Participants with an inability to comply with listed restrictions, precautions and prohibited treatments.
  • Participants must not have prior CAR-T, Cereblon-modulating drug or radiotherapy ≤ 4 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic SCT ≤ 6 months or autologous SCT ≤ 3 months prior to study intervention initiation.
  • Participants must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.
  • Participants must not have known or suspected central nervous system involvement.

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A1
Single Agent
Drug: BMS-986458
Specified dose on specified days.
Experimental: Part A2
Combination Treatment
Drug: BMS-986458
Specified dose on specified days.
Drug: Rituximab
Specified dose on specified days.
Experimental: Part B1
Single Agent
Drug: BMS-986458
Specified dose on specified days.
Experimental: Part B2
Combination Treatment
Drug: BMS-986458
Specified dose on specified days.
Drug: Rituximab
Specified dose on specified days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 2 years and 1 month
Up to 2 years and 1 month
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 2 years and 1 month
Up to 2 years and 1 month
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time Frame: Up to 2 years and 1 month
Up to 2 years and 1 month
Number of participants with AEs leading to discontiunation
Time Frame: Up to 2 years and 1 month
Up to 2 years and 1 month
Number of participants with AEs leading to death
Time Frame: Up to 2 years and 1 month
Up to 2 years and 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to 2 years
Up to 2 years
Progression-free survival (PFS)
Time Frame: Up to 2 years
Up to 2 years
Duration of response (DOR)
Time Frame: Up to 2 years
Up to 2 years
Time to response (TTR)
Time Frame: Up to 2 years
Up to 2 years
Maximum concentration (Cmax)
Time Frame: Up to 4 months
Up to 4 months
Time of maximum concentration (Tmax)
Time Frame: Up to 4 months
Up to 4 months
Area under the plasma concentration-time curve (AUC(0-T))
Time Frame: Up to 4 months
Up to 4 months
Number of participants with an overall response rate (ORR) according to the Lugano response criteria for Non-Hodgkin Lymphoma
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)

December 29, 2023

Primary Completion (Estimated)

October 28, 2027

Study Completion (Estimated)

October 28, 2028

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA123-1000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-andresearch/ disclosure-commitment.html

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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