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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-503007-22 | EudraCT Number | ||
| U1111-1282-5699 | Other Identifier | WHO |
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Business objectives have changed
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT | Experimental |
| |
| Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT | Experimental |
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| Part 2: Nivolumab + Histology-based PDCT | Active Comparator |
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| Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT | Experimental |
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| Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986315 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) |
| 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. | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) |
| 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. | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) |
| 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
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0038 | Glendale | California | 37219 | United States | ||
| Local Institution - 0044 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
See Plan Description
See Plan Description
In Part 1 one participant received study treatment. In Part 2 no participants were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Part 2 Arm A: Nivolumab + Histology-based Chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 21, 2023 |
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| Nivolumab | Drug | Specified dose on specified days |
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| Pemetrexed | Drug | Specified dose on specified days |
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| Cisplatin | Drug | Specified dose on specified days |
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| Carboplatin | Drug | Specified dose on specified days |
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| Paclitaxel | Drug | Specified dose on specified days |
|
| From first dose (Cycle 1 Day 1) up to day 28 |
| 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. | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) |
| Number of Participants Who Died in Part 1 | Number of participants who died during the study | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) |
| 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. | 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) |
| 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) |
| 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. | Up to 100 days after discontinuation of study treatment |
| 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. | Up to 100 days after discontinuation of study treatment |
| 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. | Up to 100 days after discontinuation of study treatment |
| 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
| Up to 100 days after discontinuation of study treatment |
| 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. | Up to 100 days after discontinuation of study treatment |
| 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. | Up to 100 days after discontinuation of study treatment |
| 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). | 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 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. | 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) 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| Clermont |
| Florida |
| 34711 |
| United States |
| Local Institution - 0040 | Orange City | Florida | 32763 | United States |
| Local Institution - 0058 | Boise | Idaho | 83706 | United States |
| Local Institution - 0049 | Houston | Texas | 77090 | United States |
| Local Institution - 0013 | St Leonards | New South Wales | 2065 | Australia |
| Local Institution - 0021 | Tweed Heads | New South Wales | 2485 | Australia |
| Local Institution - 0032 | Joondalup | Western Australia | 6027 | Australia |
Participant received Nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks |
| FG002 | 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 |
| FG003 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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In Part 2, no participants were enrolled, so no analysis was conducted
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Part 2 Arm A: Nivolumab + Histology-based Chemotherapy | Participant received Nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All Treated Participants for Part 1. Pre-specified to be reported for Part 1 only. | Posted | Count of Participants | Participants | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) |
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| 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. | All Treated Participants for Part 1. Pre-specified to be reported for Part 1 only. | Posted | Count of Participants | Participants | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) |
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| 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. | All Treated Participants for Part 1. Pre-specified to be reported for Part 1 only. | Posted | Count of Participants | Participants | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) |
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| 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
| All Treated Participants for Part 1. Pre-specified to be reported for Part 1 only. | Posted | Count of Participants | Participants | From first dose (Cycle 1 Day 1) up to day 28 |
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| 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. | All Treated Participants for Part 1. Pre-specified to be reported for Part 1 only. | Posted | Count of Participants | Participants | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) |
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| Primary | Number of Participants Who Died in Part 1 | Number of participants who died during the study | All Treated Participants for Part 1. Pre-specified to be reported for Part 1 only. | Posted | Count of Participants | Participants | From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) |
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| 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. | 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. | Posted | 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) |
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| 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. | 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. | Posted | 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) |
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| 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. | 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. | Posted | Up to 100 days after discontinuation of study treatment |
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| 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. | 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. | Posted | Up to 100 days after discontinuation of study treatment |
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| 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. | 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. | Posted | Up to 100 days after discontinuation of study treatment |
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| 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
| 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. | Posted | Up to 100 days after discontinuation of study treatment |
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| 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. | 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. | Posted | Up to 100 days after discontinuation of study treatment |
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| 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. | 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. | Posted | Up to 100 days after discontinuation of study treatment |
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| 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). | 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. | Posted | 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) |
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| 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. | 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. | Posted | 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) |
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| 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. | 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. | Posted | 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) |
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| 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. | 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. | Posted | 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) |
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| 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. | 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. | Posted | 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) |
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| 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. | 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. | Posted | 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) |
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| 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. | 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. | Posted | 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) |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 1 | 0 | 1 | 1 | 1 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Mar 27, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| >=65 years |
|
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| OG002 | 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 |
|
| OG002 | 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 |
|
Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks |
|
Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks |
|
|
Participant received BMS-986315 900 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks |
| OG002 | 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 |
|
Participant received BMS-986315 450 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks |
|
| Units | Counts |
|---|---|
| Participants |
|
Participant received BMS-986315 900 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks |
| OG002 | 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 |
|
| OG002 |
| 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 |
|
Participant received BMS-986315 900 mg every 3 weeks in combination with nivolumab 360 mg every 3 weeks plus chemotherapy every 3 weeks
| OG002 | 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|