This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
437
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
RECRUITINGLocal Institution - 0020
Allentown, Pennsylvania, United States
ACTIVE_NOT_RECRUITINGThe West Clinic, PLLC dba West Cancer Center
Number of participants with Adverse Events (AEs)
Time frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of participants with Serious AEs (SAEs)
Time frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria
Time frame: From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)
Number of participants with AEs leading to discontinuation
Time frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of deaths
Time frame: From time of informed consent up to 52 weeks after end of treatment visit
Maximum observed plasma concentration (Cmax)
Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Time of maximum observed concentration (Tmax)
Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Objective response rate (ORR)
Defined as the proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
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CONTACT
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CONTACT
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Specified dose on specified days
Germantown, Tennessee, United States
Local Institution - 0025
Dallas, Texas, United States
WITHDRAWNLocal Institution - 0031
Brisbane, Queensland, Australia
ACTIVE_NOT_RECRUITINGBC Cancer Vancouver
Vancouver, British Columbia, Canada
RECRUITINGLocal Institution - 0015
Montreal, Quebec, Canada
NOT_YET_RECRUITINGCentre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada
RECRUITINGTime frame: From time of informed consent up to 52 weeks after end of treatment visit
Disease control rate (DCR)
Defined as the proportion of participants who achieve a best response of CR, PR, or stable disease (SD) assessed by the investigator using RECIST v1.1
Time frame: From time of informed consent up to 52 weeks after end of treatment visit
Duration of response (DOR)
Defined as the time between the date of first documented response (CR or PR) to the date of the first documented disease progression as assessed by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first
Time frame: From time of informed consent up to 52 weeks after end of treatment visit