The purpose of this study is to determine if BMS-986310 administered in combination with nivolumab, will demonstrate adequate safety and tolerability, as well as a favorable risk/benefit profile, to support further clinical testing.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Specified dose on specified days
Specified dose on specified days
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Incidence of Adverse Events (AE)
Time frame: up to 3 years
Incidence of Serious Adverse Events (SAE)
Time frame: up to 3 years
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time frame: up to 3 years
Incidence of AEs leading to dose delays and discontinuation or delay in radical cystectomy (RC)
Time frame: up to 3 years
Incidence of Laboratory abnormalities
Time frame: up to 3 years
Incidence of death
Time frame: up to 3 years
Objective response rate (ORR)
Time frame: up to 3 years
Median duration of response (mDOR)
Time frame: up to 3 years
Progression free survival rate (PFSR)
Time frame: up to 24 months
Maximum observed serum concentration (Cmax)
Time frame: up to 3 years
Observed serum concentration at the end of a dosing interval (Ctau)
Time frame: up to 3 years
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
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Local Institution
Brussels, Belgium
Local Institution
Ghent, Belgium
Local Institution
Toronto, Ontario, Canada
Time frame: up to 3 years
Apparent total body clearance (CLT/F)
Time frame: up to 3 years
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Time frame: up to 3 years
AUC accumulation index (AI_AUC)
Time frame: up to 3 years
Cmax accumulation index (AI_Cmax)
Time frame: up to 3 years
Summary changes of prostaglandin E metabolite (PGEM) in urine
Time frame: up to 3 years
Summary changes of tumor necrosis factor (TNFa) in blood
Time frame: up to 3 years
Summary of PK parameters at T-HALF
Time frame: up to 3 years
Summary of PK parameter AUC(INF) after single dose
Time frame: up to 3 years