This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Specified dose on specified days
Local Institution - 0006
Boston, Massachusetts, United States
NOT_YET_RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGLocal Institution - 0002
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria
Time frame: Up to approximately Day 28
Number of Participants With AEs Leading to Discontinuation
Time frame: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With AEs Leading to Deaths as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0
Time frame: Up to approximately 2 years from first dose of BMS-986506
Maximum Observed Plasma Concentration (Cmax) of BMS-986506
Time frame: Up to approximately Day 85
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506
Time frame: Up to approximately Day 112
Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506
Time frame: Up to approximately Day 112
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Up to approximately 3 years from first dose of BMS-986506
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Philadelphia, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGSTART San Antonio
San Antonio, Texas, United States
RECRUITINGLocal Institution - 0021
Calgary, Alberta, Canada
NOT_YET_RECRUITINGLocal Institution - 0008
Villejuif, Val-de-Marne, France
NOT_YET_RECRUITINGLocal Institution - 0015
Córdoba, Andalusia, Spain
NOT_YET_RECRUITINGLocal Institution - 0018
Barcelona, Barcelona [Barcelona], Spain
NOT_YET_RECRUITINGDisease Control Rate (DCR) as Assessed by RECIST v1.1
Time frame: Up to approximately 3 years from first dose of BMS-986506
Duration of Response (DOR) as Assessed by RECIST v1.1
Time frame: Up to approximately 3 years from first dose of BMS-986506
Time to Response (TTR) as Assessed by RECIST v1.1
Time frame: Up to approximately 3 years from first dose of BMS-986506