Trial Outcomes & Findings for A Study of BMS-986315 and Nivolumab in Combination With Chemotherapy in Participants With First-line Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) (NCT NCT06094296)

NCT ID: NCT06094296

Last Updated: 2025-04-16

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)
• Results posted on: 2025-04-16

Participant Flow

In Part 1 one participant received study treatment. In Part 2 no participants were enrolled.

Participant milestones

Measure	Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm A: Nivolumab + Histology-based Chemotherapy Participant received Nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm B: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 900 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm C: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks
Overall Study STARTED	1	0	0	0
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	1	0	0	0

Reasons for withdrawal

Measure	Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm A: Nivolumab + Histology-based Chemotherapy Participant received Nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm B: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 900 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm C: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks
Overall Study Progressive Disease	1	0	0	0

Baseline Characteristics

A Study of BMS-986315 and Nivolumab in Combination With Chemotherapy in Participants With First-line Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Measure	Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy n=1 Participants Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm A: Nivolumab + Histology-based Chemotherapy Participant received Nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm B: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 900 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm C: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	—	—	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	—	—	—	1 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	—	—	0 Participants n=21 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	—	—	—	NA Participants n=21 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	—	—	—	NA Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	NA Participants n=5 Participants	—	—	—	NA Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	NA Participants n=5 Participants	—	—	—	NA Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	NA Participants n=5 Participants	—	—	—	NA Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	NA Participants n=5 Participants	—	—	—	NA Participants n=21 Participants
Race (NIH/OMB) Asian	NA Participants n=5 Participants	—	—	—	NA Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	NA Participants n=5 Participants	—	—	—	NA Participants n=21 Participants
Race (NIH/OMB) Black or African American	NA Participants n=5 Participants	—	—	—	NA Participants n=21 Participants
Race (NIH/OMB) White	NA Participants n=5 Participants	—	—	—	NA Participants n=21 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants	—	—	—	NA Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	NA Participants n=5 Participants	—	—	—	NA Participants n=21 Participants

PRIMARY outcome

Timeframe: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

Population: All Treated Participants for Part 1. Pre-specified to be reported for Part 1 only.

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.

Outcome measures

Measure	Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy n=1 Participants Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm B: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 900 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm C: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks
Number of Participants With Adverse Events (AEs) for Part 1	1 Participants	—	—

PRIMARY outcome

Timeframe: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

Population: All Treated Participants for Part 1. Pre-specified to be reported for Part 1 only.

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.

Outcome measures

Measure	Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy n=1 Participants Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm B: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 900 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm C: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks
Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 1	1 Participants	—	—

PRIMARY outcome

Timeframe: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

Population: All Treated Participants for Part 1. Pre-specified to be reported for Part 1 only.

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.

Outcome measures

Measure	Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy n=1 Participants Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm B: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 900 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm C: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks
Number of Participants With Serious Adverse Events (SAEs) for Part 1	0 Participants	—	—

PRIMARY outcome

Timeframe: From first dose (Cycle 1 Day 1) up to day 28

Population: All Treated Participants for Part 1. Pre-specified to be reported for Part 1 only.

Dose-Limiting Toxicities (DLTs) are treatment effects serious enough to prevent dose increase.

Severity grades: 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death

• Grade 2 uveitis or eye pain not improving or require systemic treatment
• Grade 2 pneumonitis or interstitial lung disease >14 days
• Grade ≥ 3 uveitis, episcleritis, iritis, pneumonitis, bronchospasm or neurologic toxicity
• Grade 3 colitis not responding >48 hours
• Hepatic abnormalities without liver metastases: serum transaminases (AST/ALT) >5x & ≤ 8xULN for >2weeks, AST/ALT >8xULN regardless of duration, total bilirubin >3xULN, or concurrent AST/ALT >3xULN & total bilirubin >2xULN
• Hepatic abnormalities with liver metastases: AST/ALT >8x & ≤10xULN for >2 weeks, AST/ALT >10xULN regardless of duration, total bilirubin > 3xULN, or concurrent AST/ALT >8xULN & total bilirubin >2xULN
• Grade 3 (hypersensitivity reaction not resolving to Grade 1 in 6 hours; fatigue >7 days; nausea, vomiting, or diarrhea >72 hours)

Outcome measures

Measure	Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy n=1 Participants Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm B: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 900 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm C: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks
Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 1	0 Participants	—	—

PRIMARY outcome

Timeframe: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

Population: All Treated Participants for Part 1. Pre-specified to be reported for Part 1 only.

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.

Outcome measures

Measure	Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy n=1 Participants Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm B: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 900 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm C: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks
Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 1	0 Participants	—	—

PRIMARY outcome

Timeframe: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

Population: All Treated Participants for Part 1. Pre-specified to be reported for Part 1 only.

Number of participants who died during the study

Outcome measures

Measure	Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy n=1 Participants Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm B: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 900 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks	Part 2 Arm C: BMS-986315 + Nivolumab + Histology-based Chemotherapy Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks
Number of Participants Who Died in Part 1	0 Participants	—	—

PRIMARY outcome

Timeframe: From randomization until the date of first objectively documented progression or start of subsequent therapy whichever occurred first (planned for up to approximately 5 years)

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants.

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.

No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years)

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

Progression free survival is defined as the time between the date of randomization and the first date of documented progression, per blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), or death due to any cause, whichever occurs first.

Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on 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 5mm (Note: The appearance of 1or more new lesions is also considered progression).

No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 100 days after discontinuation of study treatment

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

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.

No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 100 days after discontinuation of study treatment

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

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.

No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 100 days after discontinuation of study treatment

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

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.

No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 100 days after discontinuation of study treatment

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

Dose-Limiting Toxicities (DLTs) are treatment effects serious enough to prevent dose increase.

Severity grades: 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death

• Grade 2 uveitis or eye pain not improving or require systemic treatment
• Grade 2 pneumonitis or interstitial lung disease >14 days
• Grade ≥ 3 uveitis, episcleritis, iritis, pneumonitis, bronchospasm or neurologic toxicity
• Grade 3 colitis not responding >48 hours
• Hepatic abnormalities without liver metastases: serum transaminases (AST/ALT) >5x & ≤ 8xULN for >2weeks, AST/ALT >8xULN regardless of duration, total bilirubin >3xULN, or concurrent AST/ALT >3xULN & total bilirubin >2xULN
• Hepatic abnormalities with liver metastases: AST/ALT >8x & ≤10xULN for >2 weeks, AST/ALT >10xULN regardless of duration, total bilirubin > 3xULN, or concurrent AST/ALT >8xULN & total bilirubin >2xULN
• Grade 3 (hypersensitivity reaction not resolving to Grade 1 in 6 hours; fatigue >7 days; nausea, vomiting, or diarrhea >72 hours)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 100 days after discontinuation of study treatment

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

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.

No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 100 days after discontinuation of study treatment

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

Number of participants who died during the study

No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years)

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm.

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 the diameters of target lesions, taking as reference the smallest sum on 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 5mm (Note: The appearance of 1or more new lesions is also considered progression).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years)

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

Time to response (TTR) assessed by BICR is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria.

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.

No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years)

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

Disease control rate (DCR) is defined as the number of participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments (using RECIST 1.1) divided by the number of all randomized participants.

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.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.

No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (Each Cycle is of 21 Days)

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

Cmax is the maximum observed serum concentration.

No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: C1D1, C1D2, C1D4, C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C5D2, C5D4, C5D8, C5D15, Day 1 of every 4 cycles from cycle 6 (up to 2 years); at 30 and 100 days post last dose (Each Cycle is of 21 Days)

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

Tmax is the time of maximum observed serum concentration.

No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: C1D1, C1D2, C1D4, C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C5D2, C5D4, C5D8, C5D15, Day 1 of every 4 cycles from cycle 6 (up to 2 years); at 30 and 100 days post last dose (Each Cycle is of 21 Days)

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

AUC (0-T) is the area under the serum concentration-time curve from time zero to time of last quantifiable concentration.

No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Day 1 of every 4 cycles from cycle 6 (up to 2 years); at 30 and 100 days post last dose (Each Cycle is of 21 Days)

Population: Pre-specified to be reported for Part 2 only. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

Number of Participants with Anti-drug Antibodies (ADA) to BMS-986315

No participants were enrolled in Part 2 due to the study's termination; therefore, no data were collected for this endpoint.

Outcome measures

Outcome data not reported

Adverse Events

Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy n=1 participants at risk Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks
Blood and lymphatic system disorders Anaemia	100.0% 1/1 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 7 months). SAEs and Other AEs were assessed from first dose through 100 days following last dose of study treatment (up to approximately 7 months). All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. In Part 1 one participant received study treatment. In Part 2 no participants were enrolled.
General disorders Fatigue	100.0% 1/1 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 7 months). SAEs and Other AEs were assessed from first dose through 100 days following last dose of study treatment (up to approximately 7 months). All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. In Part 1 one participant received study treatment. In Part 2 no participants were enrolled.
Metabolism and nutrition disorders Hyponatraemia	100.0% 1/1 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 7 months). SAEs and Other AEs were assessed from first dose through 100 days following last dose of study treatment (up to approximately 7 months). All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. In Part 1 one participant received study treatment. In Part 2 no participants were enrolled.
Psychiatric disorders Depression	100.0% 1/1 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 7 months). SAEs and Other AEs were assessed from first dose through 100 days following last dose of study treatment (up to approximately 7 months). All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. In Part 1 one participant received study treatment. In Part 2 no participants were enrolled.
Psychiatric disorders Insomnia	100.0% 1/1 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 7 months). SAEs and Other AEs were assessed from first dose through 100 days following last dose of study treatment (up to approximately 7 months). All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. In Part 1 one participant received study treatment. In Part 2 no participants were enrolled.
Skin and subcutaneous tissue disorders Rash	100.0% 1/1 • Participants were assessed for All-Cause Mortality from first dose until study completion (up to approximately 7 months). SAEs and Other AEs were assessed from first dose through 100 days following last dose of study treatment (up to approximately 7 months). All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. In Part 1 one participant received study treatment. In Part 2 no participants were enrolled.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER