A Study of BMS-986205 Alone and in Combination With Nivolumab in Chinese Patients With Advanced Malignant Solid Tumors

実験的：Experimental Arm A

2 week BMS-986205 monotherapy lead in followed by BMS-986205 + Nivo combination therapy

薬：BMS-986205

Specified Dose on Specified Day

生物学的：Nivolumab

Specified Dose on Specified Day

他の名前：

• BMS-936558

The Number of Participants Experiencing Adverse Events (AE)

The number of participants experiencing adverse events (AEs) to assess the safety and tolerability of BMS-986205.

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

The Number of Participants Experiencing Serious Adverse Events (SAE)

The number of participants experiencing serious adverse events (SAEs) to assess the safety and tolerability of BMS-986205

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

The Number of Participants Experience Adverse Events (AE) Leading to Discontinuation

The number of participants experiencing adverse events (AEs) leading to discontinuation to assess the safety and tolerability of BMS-986205

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Number of Participant Deaths

The number of participants who died in each arm during the study to assess the safety and tolerability of BMS-986205.

The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests

The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units to assess the safety and tolerability of BMS-986205.

The number of participants with the following laboratory abnormalities will be summarized:

ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN Total bilirubin > 1.5 x ULN and 2 x ULN Concurrent (within 1 day) ALT or AST > 3 x ULN with total bilirubin > 2 x ULN Concurrent (within 30 days) ALT or AST > 3 x ULN with total bilirubin > 2 x ULN

The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests

The number of participants with clinical laboratory test abnormalities based on US conventional units to assess the safety and tolerability of BMS-986205.

The number of subjects with the following laboratory abnormalities will be summarized:

TSH > ULN WITH TSH <= ULN AT BASELINE WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN (Within a 2-week window after the abnormal TSH test date) WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN (Within a 2-week window after the abnormal TSH test date) WITH FT3/FT4 TEST MISSING (Within a 2-week window after the abnormal TSH test date) TSH < LLN WITH TSH >= LLN AT BASELINE WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN (Within a 2-week window after the abnormal TSH test date) WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN (Within a 2-week window after the abnormal TSH test date) WITH FT3/FT4 TEST MISSING (Within a 2-week window after the abnormal TSH test date)

(Cmax) Maximum Observed Plasma Concentration

The maximum observes plasma concentration was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab.

(Tmax) Time of Maximum Observed Plasma Concentration

The time of maximum observed plasma concentration was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab.

(AUC(TAU)) Area Under the Concentration-time Curve in One Dosing Interval

The area under the concentration-time curve in one dosing interval was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab.

(CLT/F) Apparent Total Body Clearance

The apparent total body clearance was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab.

(T-HALF (Eff, AUC)) Effective Elimination Half-life

The effective elimination half-life was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. T-HALF (eff, AUC) explains the degree of AUC accumulation observed.

(AI_CMAX) Accumulation Index

The accumulation index was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. AI is calculated based on ratio of Cmax at steady state to after the first dose.

(AI_AUC ) Accumulation Index

The accumulation index was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. AI is calculated based on ratio of AUC(TAU) at steady state to after the first dose.

(Ctrough) Trough Observed Plasma Concentration

The trough observed plasma concentration was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab.

(percentUR24) Percent Urinary Recovery Over 24 Hours

The percent urinary recovery over 24 hours was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab.

BMS-986205 had minimal evaluable concentration in urine to derive the parameter.

Objective Response Rate (ORR)

ORR is defined as the total number of participants whose best overall response (BOR) is either a completer response (CR) or partial response (PR) divided by the total number of participants in the population of interest. Assessed per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigator

BOR is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy.

Best Overall Response (BOR)

BOR defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. Assessed per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigator

Duration of Response (DOR)

Duration of Response (DOR) is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Assessed per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigator.

Measurement of Serum Kynurenine Levels

Measurement of kynurenine levels were assessed to characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab.

Measurement of Tryptophan Levels

Measurement of tryptophan levels were assessed to characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab.

Number of Participants With Anti-drug Antibodies (ADA) to Nivolumab

The number of participants with positive or negative anti-drug antibodies (ADA) to nivolumab was collected to characterize the immunogenicity of nivolumab when administered in combination with BMS-986205.

Baseline ADA Positive: A subject with baseline ADA-positive sample. ADA Positive: A subject with at least one ADA-positive sample relative to baseline.

Neutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected post-baseline ADA Negative: A subject with no ADA-positive sample after initiation of treatment.