The purpose of this study is to investigate safety of experimental medication BMS-986242 and Nivolumab in patients with advanced cancers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Specified dose on specified days
Specified dose on specified days
University Of Alabama At Birmingham
Birmingham, Alabama, United States
Hoag Memorial Hospital Presbyterian
Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Local Institution
Baltimore, Maryland, United States
Number of Participants With Adverse Events (AE)
The primary objective to establish safety to be measured by the primary endpoint of AEs
Time frame: From initiation of study treatment until 100 days after discontinuation of study treatment
Number of Participants With Serious Adverse Events (SAE)
The primary objective to establish safety to be measured by the primary endpoint of SAEs
Time frame: From the date of participant's written consent until 100 days after discontinuation of nivolumab or participation in the study
Number of Participants With Dose Limiting Toxicities (DLT)
The primary objective to establish safety to be measured by the primary endpoint of dose limiting toxicities
Time frame: Approximately 2 years
Number of Participants With AEs Leading to Discontinuation
The primary objective to establish safety to be measured by the primary endpoint of AEs leading to discontinuation
Time frame: Approximately 2 years
Number of Deaths
The primary objective to establish safety to be measured by the primary endpoint of deaths
Time frame: Approximately 2 years
Number of Participants With Laboratory Abnormalities
The primary objective to establish safety to be measured by the primary endpoint of clinical laboratory test abnormalities
Time frame: Approximately 2 years
Maximum Observed Plasma Concentration (Cmax)
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
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Time frame: Approximately 2 years
Time of Maximum Observed Plasma Concentration (Tmax)
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time frame: Approximately 2 years
Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)]
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time frame: Approximately 2 years
Area Under the Concentration-time Curve From Time Zero to Infinity [AUC(INF)]
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time frame: Approximately 2 years
Trough Observed Plasma Concentration at the End of the Dosing Interval (Ctrough)
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time frame: Approximately 2 years
Apparent Elimination Half-life (T-HALF)
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time frame: Approximately 2 years
Apparent Total Body Clearance (CLT/F)
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time frame: Approximately 2 years
Apparent Volume of Distribution at Steady State (Vss/F)
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time frame: Approximately 2 years
Accumulation Index (AI)
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0. Accumulation index, calculated based on ratio of area under the curve (AUC) and Cmax at steady state to after the first dose.
Time frame: Approximately 2 years
Percent Urinary Recovery Over 24 Hours (%UR24)
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time frame: Approximately 2 years
Percent Urinary Recovery Over 72 Hours (%UR72)
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Time frame: Approximately 2 years
Incidence of Anti-drug Antibody (ADA) to Nivolumab in Combination With BMS-986242
Baseline ADA-positive participant is defined as a participant who has a ADA detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment.
Time frame: Approximately 2 years
Overall Response Rate (ORR)
ORR in participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors
Time frame: Approximately 2 years