NSCLC
Conditions
Keywords
Pharmacokinetics, BMS-986315, Nivolumab, Platinum doublet chemotherapy, NSCLC, Lung cancer
Brief summary
The purpose of this study is to evaluate the efficacy and safety of BMS-986315 plus nivolumab in combination with platinum-based doublet chemotherapy (PDCT) versus nivolumab in combination with PDCT in the first-line treatment of Stage IV or recurrent non-small cell lung cancer (NSCLC).
Interventions
DRUGBMS-986315
Specified dose on specified days
DRUGNivolumab
Specified dose on specified days
DRUGPemetrexed
Specified dose on specified days
DRUGCisplatin
Specified dose on specified days
DRUGCarboplatin
Specified dose on specified days
DRUGPaclitaxel
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have NSCLC with Stage IV or recurrent disease following multimodal therapy for locally advanced disease. * Study treatment must be first-line therapy for Stage IV or recurrent disease. * Participants in all parts of the study must have: * measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1. (RECIST v1.1) * an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * a life expectancy of at least 3 months at the time of first dose
Exclusion criteria
* Untreated symptomatic central nervous system metastases * Participants with epidermal growth factor receptor (EGFR)/ALK receptor tyrosine kinase (ALK)/ROS proto-oncogene 1 (ROS1)/neurotrophic tyrosine receptor kinase (NTRK)/MET proto-oncogene (MET)/B-Raf proto-oncogene (BRAF)/RET proto-oncogene (RET) mutations amenable to targeted therapies * Participants with any known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) for Part 1 | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) | 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. |
| Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 1 | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) | 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. |
| Number of Participants With Serious Adverse Events (SAEs) for Part 1 | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) | 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. |
| Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 1 | From first dose (Cycle 1 Day 1) up to day 28 | 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) |
| Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 1 | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) | 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. |
| Number of Participants Who Died in Part 1 | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) | Number of participants who died during the study |
| Objective Response Rate (ORR) for Part 2 | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DoR) for Part 2 | 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) | 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). |
| Time to Objective Response (TTR) for Part 2 | 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) | 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. |
| Disease Control Rate (DCR) for Part 2 | 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) | 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. |
| Progression Free Survival (PFS) for Part 2 | 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) | 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. |
| Time of Maximum Observed Concentration (Tmax) for Part 2 | 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) | 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. |
| Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for Part 2 | 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) | 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. |
| Number of Participants With Anti-drug Antibodies (ADA) to BMS-986315 for Part 2 | 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) | 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. |
| Maximum Observed Serum Concentration (Cmax) for Part 2 | 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) | 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. |
| Number of Participants With Adverse Events (AEs) for Part 2 | Up to 100 days after discontinuation of study treatment | 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. |
| Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 2 | Up to 100 days after discontinuation of study treatment | 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. |
| Number of Participants With Serious Adverse Events (SAEs) for Part 2 | Up to 100 days after discontinuation of study treatment | 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. |
| Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 2 | Up to 100 days after discontinuation of study treatment | 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) |
| Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 2 | Up to 100 days after discontinuation of study treatment | 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. |
| Number of Participants Who Died in Part 2 | Up to 100 days after discontinuation of study treatment | 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. |
Countries
Australia, United States
Participant flow
Pre-assignment details
In Part 1 one participant received study treatment. In Part 2 no participants were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1 |
| Part 2 Arm A: Nivolumab + Histology-based Chemotherapy Participant received Nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks | 0 |
| 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 | 0 |
| 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 | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Progressive Disease | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | NA Participants | NA Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | NA Participants | NA Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | NA Participants | NA Participants |
| Race (NIH/OMB) American Indian or Alaska Native | NA Participants | NA Participants |
| Race (NIH/OMB) Asian | NA Participants | NA Participants |
| Race (NIH/OMB) Black or African American | NA Participants | NA Participants |
| Race (NIH/OMB) More than one race | NA Participants | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | NA Participants | NA Participants |
| Race (NIH/OMB) Unknown or Not Reported | NA Participants | NA Participants |
| Race (NIH/OMB) White | NA Participants | NA Participants |
| Sex: Female, Male Female | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Number of Participants Who Died in Part 1
Number of participants who died during the study
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy | Number of Participants Who Died in Part 1 | 0 Participants |
Primary
Number of Participants With Adverse Events (AEs) for Part 1
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy | Number of Participants With Adverse Events (AEs) for Part 1 | 1 Participants |
Primary
Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 1
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy | Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 1 | 0 Participants |
Primary
Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 1
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)
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 1 | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) for Part 1
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 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy | Number of Participants With Serious Adverse Events (SAEs) for Part 1 | 0 Participants |
Primary
Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 1
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: BMS-986315 + Nivolumab + Histology-based Chemotherapy | Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 1 | 1 Participants |
Primary
Objective Response Rate (ORR) for Part 2
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.
Time frame: 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.
Secondary
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for Part 2
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.
Time frame: 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.
Secondary
Disease Control Rate (DCR) for Part 2
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.
Time frame: 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.
Secondary
Duration of Response (DoR) for Part 2
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).
Time frame: 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.
Secondary
Maximum Observed Serum Concentration (Cmax) for Part 2
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.
Time frame: 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.
Secondary
Number of Participants Who Died in Part 2
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.
Time frame: 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.
Secondary
Number of Participants With Adverse Events (AEs) for Part 2
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.
Time frame: 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.
Secondary
Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 2
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.
Time frame: 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.
Secondary
Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 2
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)
Time frame: 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.
Secondary
Number of Participants With Anti-drug Antibodies (ADA) to BMS-986315 for Part 2
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.
Time frame: 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.
Secondary
Number of Participants With Serious Adverse Events (SAEs) for Part 2
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.
Time frame: 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.
Secondary
Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 2
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.
Time frame: 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.
Secondary
Progression Free Survival (PFS) for Part 2
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.
Time frame: 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.
Secondary
Time of Maximum Observed Concentration (Tmax) for Part 2
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.
Time frame: 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.
Secondary
Time to Objective Response (TTR) for Part 2
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.
Time frame: 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.