A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination With Nivolumab in Participants With Relapsed/Refractory Small Cell Lung Cancer
Summary
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
Arms & interventions
- DrugBMS-986525
Specified dose on specified days
- DrugNivolumab
Specified dose on specified days
Outcome measures
Primary
Number 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
Secondary
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
Eligibility criteria
Study locations (5)
Local Institution - 0011
Detroit, Michigan, 48201
Local Institution - 0026
Buffalo, New York, 14263
Duke Cancer Institute
Durham, North Carolina, 27710
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
SCRI Oncology Partners
Nashville, Tennessee, 37203