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The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: BMS-986408 Monotherapy | Experimental |
| |
| Part 2: BMS-986408 in combination with nivolumab | Experimental |
| |
| Part 2: BMS-986408 in combination with nivolumab and ipilimumab | Experimental |
| |
| Part 2: BMS-986408 in combination with nivolumab and chemotherapy | Experimental |
| |
| Part 2: BMS-986408 in combination with rabeprazole | Experimental |
| |
| Part 3: BMS-986408 in combination with nivolumab | Experimental |
| |
| Part 3: BMS-986408 in combination with nivolumab and chemotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986408 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | A Dose-Limiting Toxicity (DLT) is defined as a treatment-related adverse event that meets specific severity criteria, excluding those clearly due to disease progression or unrelated causes. DLTs include: any Grade ≥3 non-hematologic toxicity (with exceptions like transient nausea, fatigue, rash, or electrolyte imbalances), significant liver enzyme elevations, Grade 4 neutropenia >7 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding, febrile neutropenia, and any Grade ≥3 immune-mediated toxicity including myocarditis, myelitis, or severe skin reactions. Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization. | From first dose (Day 1) till 28 days |
| Number of Participants With Adverse Events | 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. 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 (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 untill 100 days after last dose (up to approximately 15 months) for group D |
| Number of Participants Who Died | From first dose (Day 1) until 100 days after the last dose (Up to approximately 15 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of BMS-986408 | Blood samples were collected to assess pharmacokinetic parameters | Day 1 and 15 of Cycle 1 (Each cycle is of 28 days) |
| Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986408 |
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Inclusion Criteria:
Exclusion Criteria:
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 - 0010 | Boston | Massachusetts | 02215 | United States | ||
| Local Institution - 0001 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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Participants were not enrolled in Part 3.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 (Group A) BMS-986408 0.75 mg QD | Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD). |
| FG001 | Part 1 (Group A) BMS-986408 1.5 mg QD |
| 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 | Dec 11, 2023 |
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| Experimental |
|
| Nivolumab | Biological | Specified dose on specified days |
|
|
| Ipilimumab | Biological | Specified dose on specified days |
|
|
| Platinum-doublet chemotherapy | Biological | Specified dose on specified days |
|
|
| Rabeprazole | Drug | Specified dose on specified days |
|
Blood samples were collected to assess pharmacokinetic parameters
| Day 1 and 15 of Cycle 1 (Each cycle is of 28 days) |
| Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration [AUC(0-T)] | Blood samples were collected to assess pharmacokinetic parameters. | Day 1 and 15 of Cycle 1 (Each cycle is of 28 days) |
| Objective Response Rate (ORR) Per RECIST v1.1 | ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. 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. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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 5 mm. | From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy or death, whichever occurs first (up to approximately 12 months) |
| Duration of Response Per RECIST v1.1 | DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method. 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. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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 5 mm. | From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy or death, whichever occurs first (up to approximately 12 months) |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| Local Institution - 0003 | Houston | Texas | 77030 | United States |
| Local Institution - 0007 | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution - 0011 | Hamilton | Ontario | L8V5C2 | Canada |
| Local Institution - 0005 | Ottawa | Ontario | K1H 8L6 | Canada |
| Local Institution - 0006 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution - 0015 | Bordeaux | Aquitaine | 33076 | France |
| Local Institution - 0014 | Villejuif | Paris | 94800 | France |
| Local Institution - 0018 | Marseille | 13385 | France |
| Local Institution - 0019 | Toulouse | 31059 | France |
| Local Institution - 0024 | Málaga | Andalusia | 29010 | Spain |
| Local Institution - 0025 | Madrid | Madrid, Comunidad de | 28009 | Spain |
| Local Institution - 0022 | Madrid | 28040 | Spain |
| Local Institution - 0023 | Madrid | 28050 | Spain |
| Local Institution - 0021 | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Local Institution - 0012 | Basel | 4031 | Switzerland |
| Local Institution - 0020 | Geneva | 1205 | Switzerland |
Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).
| FG002 | Part 1 (Group A) BMS-986408 3 mg QD | Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD). |
| FG003 | Part 1 (Group A) BMS-986408 5 mg QD | Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD). |
| FG004 | Part 1 (Group A) BMS-986408 7.25 mg QD | Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD). |
| FG005 | Part 1 (Group B) BMS-986408 1.5 mg BID | Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID). |
| FG006 | Part 1 (Group B) BMS-986408 2.25 mg BID | Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID). |
| FG007 | Part 1 (Group B) BMS-986408 3.75 mg BID | Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID). |
| FG008 | Part 1 Group C BMS-986408 3 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD). |
| FG009 | Part 1 Group C BMS-986408 5 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD). |
| FG010 | Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| FG011 | Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| FG012 | Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 (Group A) BMS-986408 0.75 mg QD | Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD). |
| BG001 | Part 1 (Group A) BMS-986408 1.5 mg QD | Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD). |
| BG002 | Part 1 (Group A) BMS-986408 3 mg QD | Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD). |
| BG003 | Part 1 (Group A) BMS-986408 5 mg QD | Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD). |
| BG004 | Part 1 (Group A) BMS-986408 7.25 mg QD | Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD). |
| BG005 | Part 1 (Group B) BMS-986408 1.5 mg BID | Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID). |
| BG006 | Part 1 (Group B) BMS-986408 2.25 mg BID | Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID). |
| BG007 | Part 1 (Group B) BMS-986408 3.75 mg BID | Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID). |
| BG008 | Part 1 Group C BMS-986408 3 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD). |
| BG009 | Part 1 Group C BMS-986408 5 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD). |
| BG010 | Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| BG011 | Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| BG012 | Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| BG013 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 Dose Limiting Toxicities (DLTs) | A Dose-Limiting Toxicity (DLT) is defined as a treatment-related adverse event that meets specific severity criteria, excluding those clearly due to disease progression or unrelated causes. DLTs include: any Grade ≥3 non-hematologic toxicity (with exceptions like transient nausea, fatigue, rash, or electrolyte imbalances), significant liver enzyme elevations, Grade 4 neutropenia >7 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding, febrile neutropenia, and any Grade ≥3 immune-mediated toxicity including myocarditis, myelitis, or severe skin reactions. Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization. | Participants were DLT evaluable if they received ≥75% of planned BMS-986408 doses without a DLT or had a DLT after at least one dose. In Part 2, they must also have received one nivolumab dose. | Posted | Count of Participants | Participants | From first dose (Day 1) till 28 days |
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| Primary | Number of Participants With Adverse Events | 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. 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. | Safety population included all participants who received at least 1 dose of study intervention | Posted | Count of Participants | Participants | From first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 untill 100 days after last dose (up to approximately 15 months) for group D |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Plasma Concentration (Cmax) of BMS-986408 | Blood samples were collected to assess pharmacokinetic parameters | PK evaluable population included all treated participants who have any available concentration-time data. Only participants with available concentration-time data at particular timepoint were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per mililitre (ng/mL) | Day 1 and 15 of Cycle 1 (Each cycle is of 28 days) |
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| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986408 | Blood samples were collected to assess pharmacokinetic parameters | PK evaluable population included all treated participants who have any available concentration-time data. Only participants with available concentration-time data at particular timepoint were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Day 1 and 15 of Cycle 1 (Each cycle is of 28 days) |
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| Secondary | Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration [AUC(0-T)] | Blood samples were collected to assess pharmacokinetic parameters. | PK evaluable population included all treated participants who have any available concentration-time data. Only participants with with available concentration-time data at particular timepoint were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 1 and 15 of Cycle 1 (Each cycle is of 28 days) |
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| Secondary | Objective Response Rate (ORR) Per RECIST v1.1 | ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. 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. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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 5 mm. | Safety population included all participants who received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy or death, whichever occurs first (up to approximately 12 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response Per RECIST v1.1 | DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method. 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. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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 5 mm. | Safety population included all participants who received at least 1 dose of study intervention. Only confirmed responders were included in the analysis. | Posted | Median | 95% Confidence Interval | months | From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy or death, whichever occurs first (up to approximately 12 months) |
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| Primary | Number of Participants Who Died | Safety population included all participants who received at least 1 dose of study intervention | Posted | Count of Participants | Participants | From first dose (Day 1) until 100 days after the last dose (Up to approximately 15 months) |
|
All-cause mortality was collected from Day 1 and up to 107 weeks. Serious adverse events, other AEs were collected from first dose (Day 1) till 30 days after the last dose (Up to approximately 13 months) for Group A to C and from Day 1 until 100 days after last dose (up to approximately 15 months) for group D.
Safety population included all participants who received at least 1 dose of study intervention.
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 (Group A) BMS-986408 0.75 mg QD | Participants with advanced solid tumors received 0.75 mg tablets of BMS-986408 once daily (QD). | 3 | 3 | 2 | 3 | 3 | 3 |
| EG001 | Part 1 (Group A) BMS-986408 1.5 mg QD | Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD). | 4 | 6 | 1 | 6 | 6 | 6 |
| EG002 | Part 1 (Group A) BMS-986408 3 mg QD | Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD). | 3 | 7 | 2 | 7 | 6 | 7 |
| EG003 | Part 1 (Group A) BMS-986408 5 mg QD | Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD). | 6 | 11 | 7 | 11 | 11 | 11 |
| EG004 | Part 1 (Group A) BMS-986408 7.25 mg QD | Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD). | 0 | 3 | 2 | 3 | 3 | 3 |
| EG005 | Part 1 (Group B) BMS-986408 1.5 mg BID | Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID). | 3 | 4 | 3 | 4 | 4 | 4 |
| EG006 | Part 1 (Group B) BMS-986408 2.25 mg BID | Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID). | 4 | 5 | 4 | 5 | 5 | 5 |
| EG007 | Part 1 (Group B) BMS-986408 3.75 mg BID | Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID). | 2 | 2 | 2 | 2 | 2 | 2 |
| EG008 | Part 1 Group C BMS-986408 3 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD). | 3 | 6 | 4 | 6 | 6 | 6 |
| EG009 | Part 1 Group C BMS-986408 5 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD). | 4 | 7 | 3 | 7 | 7 | 7 |
| EG010 | Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). | 3 | 8 | 3 | 8 | 8 | 8 |
| EG011 | Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). | 2 | 5 | 3 | 5 | 5 | 5 |
| EG012 | Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). | 0 | 1 | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Immune-mediated pancytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ureteric rupture | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Assisted suicide | Surgical and medical procedures | MedDRA 27.0 | Systematic Assessment |
| |
| Embolism arterial | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aplasia pure red cell | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gingival swelling | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Regurgitation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Fungal oesophagitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Purulent discharge | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Rhinolaryngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Troponin T increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Appetite disorder | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperferritinaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mixed anxiety and depressive disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 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 |
| Aug 19, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| D017239 | Paclitaxel |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D064750 | Rabeprazole |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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 |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
Not provided
Not provided
| Male |
|
| 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 |
|
| Part 1 (Group A) BMS-986408 3 mg QD |
Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD). |
| OG003 | Part 1 (Group A) BMS-986408 5 mg QD | Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD). |
| OG004 | Part 1 (Group A) BMS-986408 7.25 mg QD | Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD). |
| OG005 | Part 1 (Group B) BMS-986408 1.5 mg BID | Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID). |
| OG006 | Part 1 (Group B) BMS-986408 2.25 mg BID | Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID). |
| OG007 | Part 1 (Group B) BMS-986408 3.75 mg BID | Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID). |
| OG008 | Part 1 Group C BMS-986408 3 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD). |
| OG009 | Part 1 Group C BMS-986408 5 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD). |
| OG010 | Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| OG011 | Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| OG012 | Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
|
|
Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).
| OG004 | Part 1 (Group A) BMS-986408 7.25 mg QD | Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD). |
| OG005 | Part 1 (Group B) BMS-986408 1.5 mg BID | Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID). |
| OG006 | Part 1 (Group B) BMS-986408 2.25 mg BID | Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID). |
| OG007 | Part 1 (Group B) BMS-986408 3.75 mg BID | Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID). |
| OG008 | Part 1 Group C BMS-986408 3 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD). |
| OG009 | Part 1 Group C BMS-986408 5 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD). |
| OG010 | Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| OG011 | Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| OG012 | Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
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Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD).
| OG004 | Part 1 (Group A) BMS-986408 7.25 mg QD | Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD). |
| OG005 | Part 1 (Group B) BMS-986408 1.5 mg BID | Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID). |
| OG006 | Part 1 (Group B) BMS-986408 2.25 mg BID | Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID). |
| OG007 | Part 1 (Group B) BMS-986408 3.75 mg BID | Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID). |
| OG008 | Part 1 Group C BMS-986408 3 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD). |
| OG009 | Part 1 Group C BMS-986408 5 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD). |
| OG010 | Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| OG011 | Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| OG012 | Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
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Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD). |
| OG004 | Part 1 (Group A) BMS-986408 7.25 mg QD | Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD). |
| OG005 | Part 1 (Group B) BMS-986408 1.5 mg BID | Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID). |
| OG006 | Part 1 (Group B) BMS-986408 2.25 mg BID | Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID). |
| OG007 | Part 1 (Group B) BMS-986408 3.75 mg BID | Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID). |
| OG008 | Part 1 Group C BMS-986408 3 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD). |
| OG009 | Part 1 Group C BMS-986408 5 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD). |
| OG010 | Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| OG011 | Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| OG012 | Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
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Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD).
| OG002 | Part 1 (Group A) BMS-986408 3 mg QD | Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD). |
| OG003 | Part 1 (Group A) BMS-986408 5 mg QD | Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD). |
| OG004 | Part 1 (Group A) BMS-986408 7.25 mg QD | Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD). |
| OG005 | Part 1 (Group B) BMS-986408 1.5 mg BID | Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID). |
| OG006 | Part 1 (Group B) BMS-986408 2.25 mg BID | Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID). |
| OG007 | Part 1 (Group B) BMS-986408 3.75 mg BID | Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID). |
| OG008 | Part 1 Group C BMS-986408 3 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD). |
| OG009 | Part 1 Group C BMS-986408 5 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD). |
| OG010 | Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| OG011 | Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| OG012 | Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
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| Part 1 (Group A) BMS-986408 1.5 mg QD |
Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 once daily (QD). |
| OG002 | Part 1 (Group A) BMS-986408 3 mg QD | Participants with advanced solid tumors received 3 mg tablets of BMS-986408 once daily (QD). |
| OG003 | Part 1 (Group A) BMS-986408 5 mg QD | Participants with advanced solid tumors received 5 mg tablets of BMS-986408 once daily (QD). |
| OG004 | Part 1 (Group A) BMS-986408 7.25 mg QD | Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD). |
| OG005 | Part 1 (Group B) BMS-986408 1.5 mg BID | Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID). |
| OG006 | Part 1 (Group B) BMS-986408 2.25 mg BID | Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID). |
| OG007 | Part 1 (Group B) BMS-986408 3.75 mg BID | Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID). |
| OG008 | Part 1 Group C BMS-986408 3 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD). |
| OG009 | Part 1 Group C BMS-986408 5 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD). |
| OG010 | Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| OG011 | Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| OG012 | Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
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| Part 1 (Group A) BMS-986408 7.25 mg QD |
Participants with advanced solid tumors received 7.25 mg tablets of BMS-986408 once daily (QD). |
| OG005 | Part 1 (Group B) BMS-986408 1.5 mg BID | Participants with advanced solid tumors received 1.5 mg tablets of BMS-986408 twice in a day (BID). |
| OG006 | Part 1 (Group B) BMS-986408 2.25 mg BID | Participants with advanced solid tumors received 2.25 mg tablets of BMS-986408 twice in a day (BID). |
| OG007 | Part 1 (Group B) BMS-986408 3.75 mg BID | Participants with advanced solid tumors received 3.75 mg tablets of BMS-986408 twice in a day (BID). |
| OG008 | Part 1 Group C BMS-986408 3 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD). |
| OG009 | Part 1 Group C BMS-986408 5 mg QD | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD). |
| OG010 | Part 2 Group D BMS-986408 1.5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 1.5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| OG011 | Part 2 Group D BMS-986408 3 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 3 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
| OG012 | Part 2 Group D BMS-986408 5 mg QD + NIVO 480 mg Q4W | Participants with advanced, unresectable/metastatic solid malignancy of the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents, and had received, were refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit received 5 mg tablets of BMS-986408 once daily (QD) and 480 mg intravenous infusion (approx. 30 minutes) once in 4 weeks (Q4W). |
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