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The purpose of this study is to determine safety and effectiveness of experimental medication BMS-986205 in combination with Nivolumab in patients with cancers that are advanced or have spread.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm A | Experimental | 2 week BMS-986205 monotherapy lead in followed by BMS-986205 + Nivo combination therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986205 | Drug | Specified Dose on Specified Day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Experiencing Adverse Events (AE) | The number of participants experiencing adverse events (AEs) to assess the safety and tolerability of BMS-986205. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | From first dose to 100 days after last dose of study therapy (up to approximately 2 years) |
| The Number of Participants Experiencing Serious Adverse Events (SAE) | The number of participants experiencing serious adverse events (SAEs) to assess the safety and tolerability of BMS-986205 Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. | From first dose to 100 days after last dose of study therapy (up to approximately 2 years) |
| The Number of Participants Experience Adverse Events (AE) Leading to Discontinuation | The number of participants experiencing adverse events (AEs) leading to discontinuation to assess the safety and tolerability of BMS-986205 An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | From first dose to 100 days after last dose of study therapy (up to approximately 2 years) |
| Number of Participant Deaths | The number of participants who died in each arm during the study to assess the safety and tolerability of BMS-986205. | From first dose to 100 days after last dose of study therapy (up to approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the total number of participants whose best overall response (BOR) is either a completer response (CR) or partial response (PR) divided by the total number of participants in the population of interest. Assessed per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigator BOR is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Hangzhou | Zhejiang | 310016 | China |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html
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| ID | Title | Description |
|---|---|---|
| FG000 | BMS-986205 in Combination With Nivolumab | Study treatment starts with a monotherapy therapy 2-week lead-in treatment (Cycle 0) consisting of a single oral daily dose of 100 mg BMS-986205. Followed by combination therapy cycles comprised of an oral daily dose of 100mg BMS-986205 and one dose of 480mg nivolumab administered intravenously Q4W on Day 1 of each treatment cycle up to 12 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BMS-986205 in Combination With Nivolumab | Study treatment starts with a monotherapy therapy 2-week lead-in treatment (Cycle 0) consisting of a single oral daily dose of 100 mg BMS-986205. Followed by combination therapy cycles comprised of an oral daily dose of 100mg BMS-986205 and one dose of 480mg nivolumab administered intravenously Q4W on Day 1 of each treatment cycle up to 12 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Number of Participants Experiencing Adverse Events (AE) | The number of participants experiencing adverse events (AEs) to assess the safety and tolerability of BMS-986205. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | All Treated Participants | Posted | Count of Participants | Participants | From first dose to 100 days after last dose of study therapy (up to approximately 2 years) |
|
First dose and 100 days after last dose of study therapy (Up to approximately 2 years)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BMS-986205 in Combination With Nivolumab | Study treatment starts with a monotherapy therapy 2-week lead-in treatment (Cycle 0) consisting of a single oral daily dose of 100 mg BMS-986205. Followed by combination therapy cycles comprised of an oral daily dose of 100mg BMS-986205 and one dose of 480mg nivolumab administered intravenously Q4W on Day 1 of each treatment cycle up to 12 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tuberculosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 10, 2018 | Dec 17, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2021 | Dec 17, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000630574 | linrodostat |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Nivolumab |
| Biological |
Specified Dose on Specified Day |
|
|
| The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests | The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units to assess the safety and tolerability of BMS-986205. The number of participants with the following laboratory abnormalities will be summarized: ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN Total bilirubin > 1.5 x ULN and 2 x ULN Concurrent (within 1 day) ALT or AST > 3 x ULN with total bilirubin > 2 x ULN Concurrent (within 30 days) ALT or AST > 3 x ULN with total bilirubin > 2 x ULN | From first dose to 100 days after last dose of study therapy (up to approximately 2 years) |
| The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests | The number of participants with clinical laboratory test abnormalities based on US conventional units to assess the safety and tolerability of BMS-986205. The number of subjects with the following laboratory abnormalities will be summarized: TSH > ULN WITH TSH <= ULN AT BASELINE WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN (Within a 2-week window after the abnormal TSH test date) WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN (Within a 2-week window after the abnormal TSH test date) WITH FT3/FT4 TEST MISSING (Within a 2-week window after the abnormal TSH test date) TSH < LLN WITH TSH >= LLN AT BASELINE WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN (Within a 2-week window after the abnormal TSH test date) WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN (Within a 2-week window after the abnormal TSH test date) WITH FT3/FT4 TEST MISSING (Within a 2-week window after the abnormal TSH test date) | From first dose to 100 days after last dose of study therapy (up to approximately 2 years) |
| (Cmax) Maximum Observed Plasma Concentration | The maximum observes plasma concentration was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 days 1, 14, Cycle 1 day 1 |
| (Tmax) Time of Maximum Observed Plasma Concentration | The time of maximum observed plasma concentration was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 days 1, 14, Cycle 1 day 1 |
| (AUC(TAU)) Area Under the Concentration-time Curve in One Dosing Interval | The area under the concentration-time curve in one dosing interval was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 days 1, 14, Cycle 1 day 1 |
| (CLT/F) Apparent Total Body Clearance | The apparent total body clearance was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14, Cycle 1 day 1 |
| (T-HALF (Eff, AUC)) Effective Elimination Half-life | The effective elimination half-life was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. T-HALF (eff, AUC) explains the degree of AUC accumulation observed. | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14 |
| (AI_CMAX) Accumulation Index | The accumulation index was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. AI is calculated based on ratio of Cmax at steady state to after the first dose. | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14 |
| (AI_AUC ) Accumulation Index | The accumulation index was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. AI is calculated based on ratio of AUC(TAU) at steady state to after the first dose. | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14 |
| (Ctrough) Trough Observed Plasma Concentration | The trough observed plasma concentration was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 2, 8, 14, Cycle 1 day 1, 2, Cycle 3, 5, 9, 13, and 17 day 1 |
| (percentUR24) Percent Urinary Recovery Over 24 Hours | The percent urinary recovery over 24 hours was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. BMS-986205 had minimal evaluable concentration in urine to derive the parameter. | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 Day 1 and 2 |
| From first dose up to approximately 2 years |
| Best Overall Response (BOR) | BOR defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. Assessed per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigator | From first dose up to approximately 2 years |
| Duration of Response (DOR) | Duration of Response (DOR) is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Assessed per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigator. | From first dose up to approximately 2 years |
| Measurement of Serum Kynurenine Levels | Measurement of kynurenine levels were assessed to characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab. | Baseline, pre-dose (C1D1), 6 hours post dose (C1D1), pre-dose (C1D2), and at disease progression (actually collected on C3D1, C6D1, C8D1, and end of treatment-an average of 12 cycles) |
| Measurement of Tryptophan Levels | Measurement of tryptophan levels were assessed to characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab. | Baseline, pre-dose (C1D1), 6 hours post dose (C1D1), pre-dose (C1D2), and at disease progression (actually collected on C3D1, C6D1, C8D1, and end of treatment-an average of 12 cycles) |
| Number of Participants With Anti-drug Antibodies (ADA) to Nivolumab | The number of participants with positive or negative anti-drug antibodies (ADA) to nivolumab was collected to characterize the immunogenicity of nivolumab when administered in combination with BMS-986205. Baseline ADA Positive: A subject with baseline ADA-positive sample. ADA Positive: A subject with at least one ADA-positive sample relative to baseline. Neutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected post-baseline ADA Negative: A subject with no ADA-positive sample after initiation of treatment. | Baseline, pre-dose (C1D1, C3D1, every 4 Cycles from C5D1), end of treatment - an average of 12 cycles, and follow up. (up to approximately 2 years) |
| FDA Safety Alerts and Recalls | View source |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Primary | The Number of Participants Experiencing Serious Adverse Events (SAE) | The number of participants experiencing serious adverse events (SAEs) to assess the safety and tolerability of BMS-986205 Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. | All Treated Participants | Posted | Count of Participants | Participants | From first dose to 100 days after last dose of study therapy (up to approximately 2 years) |
|
|
|
| Primary | The Number of Participants Experience Adverse Events (AE) Leading to Discontinuation | The number of participants experiencing adverse events (AEs) leading to discontinuation to assess the safety and tolerability of BMS-986205 An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | All Treated Participants | Posted | Count of Participants | Participants | From first dose to 100 days after last dose of study therapy (up to approximately 2 years) |
|
|
|
| Primary | Number of Participant Deaths | The number of participants who died in each arm during the study to assess the safety and tolerability of BMS-986205. | All treated Participants | Posted | Count of Participants | Participants | From first dose to 100 days after last dose of study therapy (up to approximately 2 years) |
|
|
|
| Primary | The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests | The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units to assess the safety and tolerability of BMS-986205. The number of participants with the following laboratory abnormalities will be summarized: ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN Total bilirubin > 1.5 x ULN and 2 x ULN Concurrent (within 1 day) ALT or AST > 3 x ULN with total bilirubin > 2 x ULN Concurrent (within 30 days) ALT or AST > 3 x ULN with total bilirubin > 2 x ULN | All Treated Participants | Posted | Count of Participants | Participants | From first dose to 100 days after last dose of study therapy (up to approximately 2 years) |
|
|
|
| Primary | The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests | The number of participants with clinical laboratory test abnormalities based on US conventional units to assess the safety and tolerability of BMS-986205. The number of subjects with the following laboratory abnormalities will be summarized: TSH > ULN WITH TSH <= ULN AT BASELINE WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN (Within a 2-week window after the abnormal TSH test date) WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN (Within a 2-week window after the abnormal TSH test date) WITH FT3/FT4 TEST MISSING (Within a 2-week window after the abnormal TSH test date) TSH < LLN WITH TSH >= LLN AT BASELINE WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN (Within a 2-week window after the abnormal TSH test date) WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN (Within a 2-week window after the abnormal TSH test date) WITH FT3/FT4 TEST MISSING (Within a 2-week window after the abnormal TSH test date) | All Treated Participants | Posted | Count of Participants | Participants | From first dose to 100 days after last dose of study therapy (up to approximately 2 years) |
|
|
|
| Primary | (Cmax) Maximum Observed Plasma Concentration | The maximum observes plasma concentration was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. | Evaluable PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 days 1, 14, Cycle 1 day 1 |
|
|
|
| Primary | (Tmax) Time of Maximum Observed Plasma Concentration | The time of maximum observed plasma concentration was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. | Evaluable PK Population | Posted | Median | Full Range | hours | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 days 1, 14, Cycle 1 day 1 |
|
|
|
| Primary | (AUC(TAU)) Area Under the Concentration-time Curve in One Dosing Interval | The area under the concentration-time curve in one dosing interval was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. | Evaluable PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 days 1, 14, Cycle 1 day 1 |
|
|
|
| Primary | (CLT/F) Apparent Total Body Clearance | The apparent total body clearance was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. | Evaluable PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14, Cycle 1 day 1 |
|
|
|
| Primary | (T-HALF (Eff, AUC)) Effective Elimination Half-life | The effective elimination half-life was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. T-HALF (eff, AUC) explains the degree of AUC accumulation observed. | Evaluable PK Population | Posted | Mean | Standard Deviation | Hours | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14 |
|
|
|
| Primary | (AI_CMAX) Accumulation Index | The accumulation index was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. AI is calculated based on ratio of Cmax at steady state to after the first dose. | Evaluable PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14 |
|
|
|
| Primary | (AI_AUC ) Accumulation Index | The accumulation index was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. AI is calculated based on ratio of AUC(TAU) at steady state to after the first dose. | Evaluable PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 14 |
|
|
|
| Primary | (Ctrough) Trough Observed Plasma Concentration | The trough observed plasma concentration was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. | Evaluable PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 day 2, 8, 14, Cycle 1 day 1, 2, Cycle 3, 5, 9, 13, and 17 day 1 |
|
|
|
| Primary | (percentUR24) Percent Urinary Recovery Over 24 Hours | The percent urinary recovery over 24 hours was collected to characterize the pharmacokinetics of BMS-986205 administered alone and in combination with nivolumab. BMS-986205 had minimal evaluable concentration in urine to derive the parameter. | Evaluable PK Population | Posted | pre-dose, 1, 2, 3, 4, 6, 8 hours post dose on Cycle 0 Day 1 and 2 |
|
|
| Secondary | Objective Response Rate (ORR) | ORR is defined as the total number of participants whose best overall response (BOR) is either a completer response (CR) or partial response (PR) divided by the total number of participants in the population of interest. Assessed per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigator BOR is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. | All Treated Participants | Posted | Count of Participants | Participants | From first dose up to approximately 2 years |
|
|
|
| Secondary | Best Overall Response (BOR) | BOR defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. Assessed per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigator | All treated Participants | Posted | Count of Participants | Participants | From first dose up to approximately 2 years |
|
|
|
| Secondary | Duration of Response (DOR) | Duration of Response (DOR) is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Assessed per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigator. | All treated participants with a BOR of CR or PR | Posted | Number | Weeks | From first dose up to approximately 2 years |
|
|
|
| Secondary | Measurement of Serum Kynurenine Levels | Measurement of kynurenine levels were assessed to characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab. | All Treated Participants | Posted | Mean | Standard Deviation | ng/mL | Baseline, pre-dose (C1D1), 6 hours post dose (C1D1), pre-dose (C1D2), and at disease progression (actually collected on C3D1, C6D1, C8D1, and end of treatment-an average of 12 cycles) |
|
|
|
| Secondary | Measurement of Tryptophan Levels | Measurement of tryptophan levels were assessed to characterize the pharmacodynamic activity of BMS-986205 administered alone and in combination with nivolumab. | All Treated Participants | Posted | Mean | Standard Deviation | ng/mL | Baseline, pre-dose (C1D1), 6 hours post dose (C1D1), pre-dose (C1D2), and at disease progression (actually collected on C3D1, C6D1, C8D1, and end of treatment-an average of 12 cycles) |
|
|
|
| Secondary | Number of Participants With Anti-drug Antibodies (ADA) to Nivolumab | The number of participants with positive or negative anti-drug antibodies (ADA) to nivolumab was collected to characterize the immunogenicity of nivolumab when administered in combination with BMS-986205. Baseline ADA Positive: A subject with baseline ADA-positive sample. ADA Positive: A subject with at least one ADA-positive sample relative to baseline. Neutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected post-baseline ADA Negative: A subject with no ADA-positive sample after initiation of treatment. | All Nivolumab Treated Subjects with Baseline and at Least One Post-Baseline Immunogenicity Assessment | Posted | Count of Participants | Participants | Baseline, pre-dose (C1D1, C3D1, every 4 Cycles from C5D1), end of treatment - an average of 12 cycles, and follow up. (up to approximately 2 years) |
|
|
|
| 3 |
| 12 |
| 3 |
| 12 |
| 11 |
| 12 |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Myoglobin blood increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Thyroxine increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Leukoderma | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.0 | 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.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| ALT OR AST > 20XULN |
|
| TOTAL BILIRUBIN > 1.5XULN |
|
| TOTAL BILIRUBIN > 2XULN |
|
| ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY |
|
| ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS |
|
| Title | Measurements |
|---|---|
|
| TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN |
|
| TSH > ULN WITH FT3/FT4 TEST MISSING |
|
| TSH < LLN |
|
| TSH <LLN WITH TSH >= LLN AT BASELINE |
|
| TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN |
|
| TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN |
|
| TSH < LLN WITH FT3/FT4 TEST MISSING |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Cycle0 Day14 |
|
|
| Cycle1 Day1 |
|
|
| Cycle1 Day2 |
|
|
| CYCLE3 DAY1 |
|
|
| CYCLE5 DAY1 |
|
|
| CYCLE9 DAY1 |
|
|
| CYCLE13 DAY1 |
|
|
| CYCLE17 DAY1 |
|
|
| Title | Measurements |
|---|---|
|
| PROGRESSIVE DISEASE (PD) |
|
| UNABLE TO DETERMINE (UTD) |
|
|
| CYCLE 1 D2 |
|
|
| CYCLE 3 D1 |
|
|
| CYCLE 6 D1 |
|
|
| CYCLE 8 D1 |
|
|
| END OF TREATMENT |
|
|
|
| CYCLE 1 D2 |
|
|
| CYCLE 3 D1 |
|
|
| CYCLE 6 D1 |
|
|
| CYCLE 8 D1 |
|
|
| END OF TREATMENT |
|
|
| Title | Measurements |
|---|---|
|
| ADA NEGATIVE |
|