The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458, a bifunctional cereblon-dependent ligand-directed degrader of B-cell lymphoma 6 (BCL6), as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
460
Specified dose on specified days.
Specified dose on specified days.
Specified dose on specified days
Number of participants with adverse events (AEs)
Time frame: Up to 2 years and 1 month
Number of participants with serious adverse events (SAEs)
Time frame: Up to 2 years and 1 month
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time frame: Up to Day 28
Number of participants with AEs leading to death
Time frame: Up to 2 years and 1 month
Number of participants with AEs leading to discontinuation
Time frame: Up to 2 years and 1 month
Number of participants with a complete response rate (CRR) according to the Lugano response criteria for Non-Hodgkin Lymphoma by Investigator assessment
Part B2 Cohort B only
Time frame: Up to 2 years and 11 month
Maximum concentration (Cmax)
Time frame: Up to 4 months
Time of maximum concentration (Tmax)
Time frame: Up to 4 months
Area under the plasma concentration-time curve within a dosing interval [AUC(TAU)]
Time frame: Up to 4 months
Number of participants with a complete response rate (CRR) according to the Lugano response criteria for Non-Hodgkin Lymphoma by Investigator assessment
Time frame: Up to 2 years
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, United States
RECRUITINGCity of Hope Comprehensive Cancer Center
Duarte, California, United States
RECRUITINGLocal Institution - 0068
Jacksonville, Florida, United States
NOT_YET_RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States
RECRUITINGLocal Institution - 0124
Omaha, Nebraska, United States
NOT_YET_RECRUITINGLocal Institution - 0047
Lake Success, New York, United States
COMPLETEDLocal Institution - 0037
New York, New York, United States
NOT_YET_RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITING...and 65 more locations
Number of participants with an overall response rate (ORR) according to the Lugano response criteria for Non-Hodgkin Lymphoma by investigator assessment
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 3 years
Time to response (TTR)
Time frame: Up to 3 years
Progression-free survival (PFS)
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years