search
Back to results

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

Primary Purpose

Relapsed/Refractory Non-Hodgkin Lymphoma

Status
Not yet recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-986458
Rituximab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Non-Hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • Local Institution - 0054

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A1

Part A2

Part B1

Part B2

Arm Description

Single Agent

Combination Treatment

Single Agent

Combination Treatment

Outcomes

Primary Outcome Measures

Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Number of participants with AEs leading to discontiunation
Number of participants with AEs leading to death

Secondary Outcome Measures

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

Full Information

First Posted
October 13, 2023
Last Updated
October 13, 2023
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT06090539
Brief Title
A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 20, 2023 (Anticipated)
Primary Completion Date
October 28, 2027 (Anticipated)
Study Completion Date
October 28, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Non-Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
273 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A1
Arm Type
Experimental
Arm Description
Single Agent
Arm Title
Part A2
Arm Type
Experimental
Arm Description
Combination Treatment
Arm Title
Part B1
Arm Type
Experimental
Arm Description
Single Agent
Arm Title
Part B2
Arm Type
Experimental
Arm Description
Combination Treatment
Intervention Type
Drug
Intervention Name(s)
BMS-986458
Intervention Description
Specified dose on specified days.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Specified dose on specified days.
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Time Frame
Up to 2 years and 1 month
Title
Number of participants with serious adverse events (SAEs)
Time Frame
Up to 2 years and 1 month
Title
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time Frame
Up to 2 years and 1 month
Title
Number of participants with AEs leading to discontiunation
Time Frame
Up to 2 years and 1 month
Title
Number of participants with AEs leading to death
Time Frame
Up to 2 years and 1 month
Secondary Outcome Measure Information:
Title
Maximum concentration (Cmax)
Time Frame
Up to 4 months
Title
Time of maximum concentration (Tmax)
Time Frame
Up to 4 months
Title
Area under the plasma concentration-time curve (AUC(0-T))
Time Frame
Up to 4 months
Title
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
Title
Duration of response (DOR)
Time Frame
Up to 2 years
Title
Time to response (TTR)
Time Frame
Up to 2 years
Title
Progression-free survival (PFS)
Time Frame
Up to 2 years
Title
Overall survival (OS)
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site#
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avyakta Kallam, Site 0020
Phone
626-219-9200
Facility Name
Local Institution - 0054
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

We'll reach out to this number within 24 hrs