The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Number of Participants With Adverse Events
Number of Participants with Adverse Events. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. For the reporting of all AEs, including intensity or severity, on case report forms, please follow the definitions in National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Time frame: From first dose to 100 days post last dose (Approximately 6 Months)
Number of Participants With Serious Adverse Events
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization
Time frame: From first dose to 100 days post last dose (Approximately 6 Months)
Number of Participants With Adverse Events Leading to Discontinuation
Number of Participants with adverse events leading to discontinuation
Time frame: From first dose to 100 days post last dose (Approximately 6 Months)
Number of Participants With Dose Limiting Toxicities
DLTs will be defined based on the incidence, intensity, and duration of the AEs for which no clear alternative cause is identified and will exclude events clearly related to disease progression or intercurrent illness. in addition, the following AEs will be DLTs: * Any death that is not clearly due to the underlying disease or extraneous causes * Any Grade ≥ 3 non-hematological toxicity * Any Grade myocarditis * Any Grade myelitis, encephalitis, myasthenia gravis, or Guillain-Barre syndrome * Grade 4 neutropenia of \> 7 days duration * Grade 4 thrombocytopenia. * Grade 3 thrombocytopenia with clinically significant bleeding. * Febrile neutropenia Any AE that is not clearly due to disease progression or extraneous causes that occurs within the 28-day DLT evaluation window and meets criteria for permanent discontinuation will be considered a DLT.
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, United States
Local Institution - 0096
Costa Mesa, California, United States
Local Institution - 0075
Orange, California, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Local Institution - 0027
Orlando, Florida, United States
Local Institution - 0029
Fort Wayne, Indiana, United States
Local Institution - 0022
New Orleans, Louisiana, United States
Local Institution - 0005
Grand Rapids, Michigan, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States
Local Institution - 0003
Hackensack, New Jersey, United States
...and 22 more locations
Time frame: From Cycle 1 day 1 to day 28 (28 Days)
Number of Participants Who Died
Number of Participants who died
Time frame: From first dose to 100 days post last dose (Approximately 6 Months)
CMax
Maximum observed serum concentration
Time frame: On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
Tmax
Time of maximum observed serum concentration
Time frame: On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
AUC (Tau)
Area under the serum concentration-time curve in 1 dosing interval
Time frame: On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
Number of Participants With BMS-986442 Anti Drug Antibody (ADA)
Number of participants with BMS-986442 Anti Drug Antibody (ADA)
Time frame: From first dose to 100 days post last dose (Approximately 6 Months)
Objective Response Rate (ORR) Per Recist v1.1 by Investigator
ORR is defined as the number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by Investigator, according to RECIST v1.1 criteria, divided by the number of treated participants. The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a participant receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).
Time frame: From first dose to 100 days post last dose (Approximately 6 Months)
Disease Control Rate (DCR) Per Recist v1.1 by Investigator
Disease Control Rate (DCR) is defined as the number of treated participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD) (and/or SD \> 6 months), based on investigator assessments divided by the number of all treated participants.
Time frame: From first dose to 100 days post last dose (Approximately 6 Months)