The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
213
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0003
Tucson, Arizona, United States
Local Institution - 0007
Los Angeles, California, United States
Local Institution - 0011
Grand Rapids, Michigan, United States
Local Institution - 0004
Incidence of adverse events (AEs)
Time frame: Up to approximately 2 years
Incidence of serious adverse events (SAEs)
Time frame: Up to approximately 2 years
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Time frame: Up to approximately 28 days
Incidence of AEs leading to discontinuation
Time frame: Up to approximately 2 years
Incidence of AEs leading to death
Time frame: Up to approximately 2 years
Maximum observed concentration (Cmax)
Time frame: Up to approximately 2 years
Time of maximum observed concentration (Tmax)
Time frame: Up to approximately 2 years
Area under the concentration-time curve (AUC)
Time frame: Up to approximately 2 years
Incidence of anti-drug antibodies (ADAs)
Time frame: Up to approximately 2 years
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Up to approximately 2 years
Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Sioux Falls, South Dakota, United States
Local Institution - 0013
San Antonio, Texas, United States
Local Institution - 0021
Darlinghurst, New South Wales, Australia
Local Institution - 0019
Elizabeth Vale, South Australia, Australia
Local Institution - 0017
Toronto, Ontario, Canada
Local Institution - 0016
Montreal, Quebec, Canada
Time frame: Up to approximately 2 years
Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Up to approximately 2 years