A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors

Duration of Response (DOR), computed for all treated participants with a best overall response (BOR) of complete response (CR) or partial response (PR), is defined as the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurs first, ie., DOR = disease progression date/death date -first response date + 1. For participants who remain alive and have not progressed, DOR will be censored on the date of their last tumor assessment. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time frame: From first dose up to date of disease progression or death, whichever occurs first (up to approximately 5 years)

Population: All treated participants who achieved complete or partial response and were not censored

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 and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Time frame: From first dose up to 100 days post last dose, up to approximately 3 years

Population: All treated participants

An Adverse Event (AE) leading to discontinuation is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment that leads to the discontinuation of study treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Time frame: From first dose up to 100 days post last dose, up to approximately 3 years

Population: All treated participants

Dose-limiting toxicities (DLTs) are severe adverse effects (AEs) that are attributed to BMS-813160 or the combination regimen and define the maximum tolerated dose of a medicine. DLTs will be defined based on the incidence, duration and grade of AEs for which no alternate cause can be identified. AEs will be evaluated according to the NCI CTCAE v4.03. The incidence of DLT(s) during the first 6 weeks of treatment in Part 1 (the DLT evaluation period) and 4 weeks for Part 2 will be used.

Time frame: From first dose up to 100 days post last dose, up to approximately 3 years

Population: All treated participants who completed the DLT evaluation period

The number of participants experiencing laboratory abnormalities in pre-specified selected parameters during the treatment period per CTCAE (Version 4). Laboratory abnormalities are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Time frame: From first dose up to 100 days post last dose, up to approximately 3 years

Population: All treated participants

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 up to 100 days post last dose, up to approximately 3 years

Population: All treated participants

The number of participants who died within 100 days after receiving their last dose

Time frame: From first dose up to 100 days post last dose, up to approximately 3 years

Population: All treated participants

The number of participants with ECG measurements outside of the range pre-specified in the protocol.

Time frame: From baseline up to 100 days post last dose

Population: All treated participants with out-of-range ECGs

Objective Response Rate (ORR) as determined by Investigator was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. Progression is defined as at least 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. 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.

Time frame: From first dose until disease progression, or the last response recorded (up to approximately 5 years)

Population: All treated participants

The percent change in Regulatory T Cells (Treg) were taken at prespecified timepoints. Baseline is defined as the last non-missing value prior to the first dosing.

Time frame: From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)

Population: All treated participants with immunohistochemistry data

The percent change in Tumor-Associated Macrophages (TAMs) were taken at prespecified timepoints. Baseline is defined as the last non-missing value prior to the first dosing.

Time frame: From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)

Population: All treated participants with immunohistochemistry data

PFS rate is defined as the proportion of participants who were progression free at Week 24. PFS is defined as the time from first dose to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Progression is defined at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Complete response (CR)= Disappearance of all target lesions. Pathological lymph nodes must have short axis reduction to \< 10 mm. Partial response (PR)= At least 30% decrease in sum of diameters of target lesions. Participants who died w/o prior progression were considered progressed on death date. Those alive and not progressed were censored on the last tumor assessment date. Those who started subsequent therapy without reported progression were censored at last tumor assessment prior to subsequent therapy. Those without post-baseline tumor assessment and alive were censored at first dose.

Time frame: From first dose up to Week 24

Population: All treated participants who were assessed for progression free survival at Week 24

Vital sign measurements at baseline and at the end of treatment. Baseline evaluations will be defined as evaluations with a date on or prior to the day of first dose of study treatment.

Time frame: From first dose to 100 days post last dose, up to approximately 3 years

Population: All treated participants with vital sign measurements

The total body clearance (CLT/F) is defined as the volume of plasma completely cleared of drug per unit time

Time frame: From first dose up to prespecified timepoints-C0D1, C2D14

Population: Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.

Area Under Curve (AUC) is defined as the area under the plot of plasma concentration of a drug versus time after dosage measured at 8 hours post-dose

Time frame: From first dose up to prespecified timepoints-C0D1, C2D1

Population: Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.

Area Under Curve (AUC) is defined as the area under the plot of plasma concentration of a drug versus time after dosage measured at 8 hours post-dose

Time frame: From first dose up to prespecified timepoints- C0D1, C2D1

Population: Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.

Cmax is defined as the maximum plasma concentration of the analytes at the prespecified timepoints.

Time frame: From first dose up to the prespecified timepoints, C0D1, C0D14, and C2D1

Population: Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.

The number of participants who are anti-drug antibody positive. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. ADA-positive sample is in a participant who is baseline ADA negative or with an ADA titer to be at least 4-fold or greater than baseline positive titer.

Time frame: From first dose up to prespecified timepoints-C1D1, C1D15, C2D1, C3D1, C5D1, C9D1

Population: All treated participants with baseline measurements and at least one positive ADA assessment of Nivolumab

Renal clearance is defined as the rate at which the analytes were removed from the plasma by the kidneys.

Time frame: From first dose up to prespecified timepoints-C0D1, C0D14

Population: Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.

Tmax is defined as the time in hours of the maximum observed plasma concentration

Time frame: From first dose up to the prespecified timpoints, C0D1, C0D14, AND C2D1

Population: Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.

Ctrough is defined as the concentration reached by a drug immediately before the next dose is administered

Time frame: From first dose up to prespecified timepoints, C0D1, C5D1, C0D1, C1D15, C5D1

Population: Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.