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
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGNumber 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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Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
RECRUITINGSTART San Antonio
San Antonio, Texas, United States
RECRUITINGArthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
RECRUITINGGustave Roussy
Villejuif, Val-de-Marne, France
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