Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

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) and 100 days after last dose of study therapy (up to approximately 25 months)

Population: All treated participants

A Dose Limiting Toxicity (DLT) is a treatment-related adverse event that is severe enough to prevent an increase in dose or continuation of therapy. DLTs include specific hepatic, hematologic, dermatologic, and other toxicities, such as Grade 4 liver enzyme elevations, Grade 4 cytopenias, persistent Grade 3 rashes, or serious organ toxicities unresponsive to treatment. Certain Grade 3 events (e.g., transient nausea, electrolyte imbalances) are excluded if they resolve quickly or with standard care.

Time frame: From first dose (Day 1) untill Day 28

Population: All treated participants.

Blood samples were collected to assess pharmacokinetic (PK) parameters.

Time frame: Cycle 1 Day 1

Population: Evaluable PK Population

Blood samples were collected to assess pharmacokinetic (PK) parameters.

Time frame: Cycle 1 Day 1

Population: Evaluable PK Population

Blood samples were collected to assess pharmacokinetic (PK) parameters.

Time frame: Cycle 1 Day 1

Population: Evaluable PK Population

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 the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)

Population: All treated participants. Only confirmed responders (CR or PR) were included in the analysis.

Blood samples were collected to assess pharmacokinetic (PK) parameters.

Time frame: Cycle 1 Day 1

Population: Evaluable PK Population

An ADA positive participant was defined as participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\>=) than baseline positive titer) at any time after initiation of treatment.

Time frame: Cycle 1 Day 1

Population: All treated participants with baseline and at least one post-baseline evaluable ADA assessment. Participants in Part 1A did not have at least one post-baseline evaluable assessment, hence no participants are included in analysis of Part1A.

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 the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)

Population: All treated participants.

Progression Free Survival Rates at 6 months is defined as the percentage of participants who achieve PFS at 6 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. 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: At 6 months

Population: All treated participants.

Blood samples were collected to assess pharmacokinetic (PK) parameters.

Time frame: Cycle 1 Day 1

Population: Evaluable PK Population