The purpose of this study is to assess the safety and tolerability of BMS-986525 alone and in combination with Nivolumab in participants with Relapsed/Refractory Small Cell Lung Cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Specified dose on specified days
Specified dose on specified days
Local Institution - 0011
Detroit, Michigan, United States
NOT_YET_RECRUITINGLocal Institution - 0026
Buffalo, New York, United States
NOT_YET_RECRUITINGNumber of participants with adverse events (AEs)
Time frame: Up to approximately 2 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately 2 years
Number of participants with AEs meeting dose-limiting toxicity (DLT) criteria
Time frame: Up to 21 days
Number of participants with AEs leading to discontinuation
Time frame: Up to approximately 2 years
Number of participants with AEs leading to death
Time frame: Up to approximately 2 years
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1) by investigator assessment
Time frame: Up to approximately 3 years
Maximum observed concentration within a dosing interval (Cmax)
Time frame: Up to approximately 2 years
Time of maximum observed plasma concentration within a dosing interval (Tmax)
Time frame: Up to approximately 2 years
Area under the concentration-time curve within a dosing interval (AUC(TAU))
Time frame: Up to approximately 2 years
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Local Institution - 0005
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGSCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGLocal Institution - 0001
Rozzano, Milano, Italy
NOT_YET_RECRUITINGLocal Institution - 0020
Hirakata, Osaka, Japan
NOT_YET_RECRUITINGLocal Institution - 0018
Chuo-ku, Tokyo, Japan
NOT_YET_RECRUITINGLocal Institution - 0023
Timișoara, Timiș County, Romania
NOT_YET_RECRUITINGLocal Institution - 0003
Craiova, Romania
NOT_YET_RECRUITING...and 1 more locations