A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

Time frame: From first dose (Day 1) until 100 days after the last dose (Up to approximately 15 months)

Population: Safety population included all participants who received at least 1 dose of study intervention

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

Time frame: From first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 untill 100 days after last dose (up to approximately 15 months) for group D

Population: Safety population included all participants who received at least 1 dose of study intervention

A Dose-Limiting Toxicity (DLT) is defined as a treatment-related adverse event that meets specific severity criteria, excluding those clearly due to disease progression or unrelated causes. DLTs include: any Grade ≥3 non-hematologic toxicity (with exceptions like transient nausea, fatigue, rash, or electrolyte imbalances), significant liver enzyme elevations, Grade 4 neutropenia \>7 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding, febrile neutropenia, and any Grade ≥3 immune-mediated toxicity including myocarditis, myelitis, or severe skin reactions. Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.

Time frame: From first dose (Day 1) till 28 days

Population: Participants were DLT evaluable if they received ≥75% of planned BMS-986408 doses without a DLT or had a DLT after at least one dose. In Part 2, they must also have received one nivolumab dose.

Blood samples were collected to assess pharmacokinetic parameters.

Time frame: Day 1 and 15 of Cycle 1 (Each cycle is of 28 days)

Population: PK evaluable population included all treated participants who have any available concentration-time data. Only participants with with available concentration-time data at particular timepoint were included in the analysis.

DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Time frame: From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy or death, whichever occurs first (up to approximately 12 months)

Population: Safety population included all participants who received at least 1 dose of study intervention. Only confirmed responders were included in the analysis.

Blood samples were collected to assess pharmacokinetic parameters

Time frame: Day 1 and 15 of Cycle 1 (Each cycle is of 28 days)

Population: PK evaluable population included all treated participants who have any available concentration-time data. Only participants with available concentration-time data at particular timepoint were included in the analysis.

ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Time frame: From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy or death, whichever occurs first (up to approximately 12 months)

Population: Safety population included all participants who received at least 1 dose of study intervention.

Blood samples were collected to assess pharmacokinetic parameters

Time frame: Day 1 and 15 of Cycle 1 (Each cycle is of 28 days)

Population: PK evaluable population included all treated participants who have any available concentration-time data. Only participants with available concentration-time data at particular timepoint were included in the analysis.