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
University of Arizona Cancer Center
Tucson, Arizona, United States
RECRUITINGUSC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGIncidence 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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CONTACT
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
START Midwest
Grand Rapids, Michigan, United States
RECRUITINGSanford Cancer Center
Sioux Falls, South Dakota, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGSt Vincent's Hospital
Darlinghurst, New South Wales, Australia
RECRUITINGLyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
RECRUITINGPrincess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGCentre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
RECRUITINGLocal Institution - 0023
Chuo-ku, Tokyo, Japan
NOT_YET_RECRUITING...and 1 more locations
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