The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Specified dose on specified days
Specified dose on specified days
Local Institution - 0006
Atlanta, Georgia, United States
Local Institution - 0005
Baltimore, Maryland, United States
Incidence of Adverse Events (AEs)
Time frame: Up to 100 days after the last treatment of study intervention(s)
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time frame: Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to discontinuation
Time frame: Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to death
Time frame: Up to 100 days after the last treatment of study intervention(s)
Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD)
Time frame: Up to 100 days after the last treatment of study intervention(s)
Maximum observed serum concentration (Cmax) of BMS-986416
Time frame: Up to 100 days after the last treatment of study intervention(s)
Time of maximum observed serum concentration (Tmax) of BMS-986416
Time frame: Up to 100 days after the last treatment of study intervention(s)
Trough observed serum concentration (Ctrough) of BMS-986416
Time frame: Up to 100 days after the last treatment of study intervention(s)
Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment
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Local Institution - 0002
Hackensack, New Jersey, United States
Local Institution - 0013
Cleveland, Ohio, United States
Local Institution - 0003
Pittsburgh, Pennsylvania, United States
Local Institution - 0004
Houston, Texas, United States
Local Institution - 0021
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0027
ABB, Buenos Aires F.D., Argentina
Local Institution - 0022
CABA, Buenos Aires F.D., Argentina
Local Institution - 0043
Edegem, Antwerpen, Belgium
...and 9 more locations
Time frame: Up to 2 years
Duration of Response (DOR) using RECIST 1.1 per Investigator assessment
Time frame: Up to 2 years
Incidence of clinically significant changes in ECG parameters: QTcF
QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Time frame: Up to 100 days after the last treatment of study intervention(s)