The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of BMS-986489 in Chinese participants with R/R SCLC (Relapsed/Refractory Small Cell Lung Cancer).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Specified dose on specified days
Local Institution - 0004
Beijing, Beijing Municipality, China
Local Institution - 0003
Jinan, Shandong, China
Local Institution - 0001
Linyi, Shandong, China
Local Institution - 0005
Hangzhou, Zhejiang, China
Number of participants with adverse events (AEs)
Time frame: Up to 12 months after last participant's first treatment
Number of participants with Serious AEs (SAEs)
Time frame: Up to 12 months after last participant's first treatment
Number of participants with AEs leading to discontinuation of study treatment
Time frame: Up to 12 months after last participant's first treatment
Number of participants with select AEs
Time frame: Up to 12 months after last participant's first treatment
Number of participants with immune-mediated AEs (IMAEs)
Time frame: Up to 12 months after last participant's first treatment
Number of deaths
Time frame: Up to 12 months after last participant's first treatment
Number of participants with laboratory abnormalities
Time frame: Up to 12 months after last participant's first treatment
Maximum observed concentration (Cmax) for BMS-986012
Time frame: Up to 12 months after last participant's first treatment
Time of maximum observed concentration (Tmax) for BMS-986012
Time frame: Up to 12 months after last participant's first treatment
Trough observed plasma concentration (Ctrough) for BMS-986012
Time frame: Up to 12 months after last participant's first treatment
Concentration at the end of a dosing interval (Ctau) for BMS-986012
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Local Institution - 0002
Shanghai, China
Time frame: Up to 12 months after last participant's first treatment
Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012
Time frame: Up to 12 months after last participant's first treatment
Area under the concentration-time curve within one dosing interval (AUC(TAU)) for BMS-986012
Time frame: Up to 12 months after last participant's first treatment
Total body clearance (CLT) for BMS-986012
Time frame: Up to 12 months after last participant's first treatment
Observed concentration at end of infusion (Ceoi) for BMS-986012
Time frame: Up to 12 months after last participant's first treatment
Number of participants with anti-drug antibodies (ADAs) to BMS-986012
Time frame: Up to 12 months after last participant's first treatment
Number of participants with ADAs to nivolumab
Time frame: Up to 12 months after last participant's first treatment
Ctrough for nivolumab
Time frame: Up to 12 months after last participant's first treatment
Ceoi for nivolumab
Time frame: Up to 12 months after last participant's first treatment
Overall Response (OR)
Achievement of best response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, assessed by the investigator.
Time frame: Up to 12 months after last participant's first treatment
Disease Control (DC)
Achievement of best response of CR or PR or stable disease (SD) using RECIST v1.1 criteria, assessed by the investigator.
Time frame: Up to 12 months after last participant's first treatment
Duration of Response (DOR)
Time from first response (CR or PR) to first documented disease progression by investigator or death, whichever occurs first. For participants who did not have an event, the DOR will be censored on the date of their last tumor assessment.
Time frame: Up to 12 months after last participant's first treatment