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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002199-24 | EudraCT Number |
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Business objectives have changed
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The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy | Experimental | BMS-986277 administered alone |
|
| Combination Dose Escalation Therapy | Experimental | BMS-986277 administered in combination with Nivolumab |
|
| Combination Expansion Therapy | Experimental | BMS-986277 monotherapy with option for subsequent Nivolumab therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986277 | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Adverse Event (AE) | Number of participants who experienced an AE during the course of the study. | from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months) |
| Number of Participants With a Serious Adverse Event (SAE) | Number of participants who experienced a SAE during the course of the study. | from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months) |
| Number of Participants With an Adverse Event (AE) Meeting Protocol-defined Dose Limiting Toxicity (DLT) Criteria | Number of participants who experienced an AE meeting protocol-defined DLT criteria during the course of the study. | from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months) |
| Number of Participants With an Adverse Event (AE) Leading to Discontinuation | Number of participants who experienced an AE leading to discontinuation during the course of the study. | from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months) |
| Number of Participants With an Adverse Event (AE) Leading to Death | Number of participants who experienced an AE leading to death during the course of the study. | from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months) |
| Number of Participants With a Clinical Laboratory Test Abnormality | Number of participants who experienced a clinical laboratory test abnormality during the course of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the proportion of all treated participants whose BOR is either CR or PR. BOR was determined by investigators for the reported data. Estimate of ORR and corresponding 2-sided exact 95% CI using the Clopper-Pearson method | at Weeks 8, 16 and 24 |
| Disease Control Rate (DCR) |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanford Research | Sioux Falls | South Dakota | 57104 | United States | ||
| Local Institution |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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10 participants randomized and treated
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Part 1) | BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277. |
| FG001 | Arm B (Part 1) |
| 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 | Yes | No | No | Study Protocol | Aug 15, 2018 | Nov 20, 2020 |
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| Nivolumab | Biological | Specified dose on specified days |
|
|
| from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months) |
| Number of Participants With a Vital Sign Abnormality or Other Safety Biomarkers | Number of participants who experienced a vital sign abnormality or other safety biomarkers during the course of the study. | from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months) |
DCR includes complete response (CR), partial response (PR), and stable disease (SD). Estimate of DCR and corresponding 2-sided exact 95% CI using the Clopper-Pearson method |
| at Weeks 8, 16 and 24 |
| Median Duration of Response (mDOR) | DOR for a participant with a 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 per RECIST v1.1/PCWG3 or death, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) | at Weeks 8, 16 and 24 |
| Median Progression-Free Survival (mPFS) | PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) for the median and Greenwood formula for the rate. | at Weeks 8, 16 and 24, to progression |
| Progression-Free Survival Rate (PFSR) | PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) for the median and Greenwood formula for the rate. | at Weeks 8, 16 and 24 |
| Cmax | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Cmax is defined as the maximum observed blood concentration. | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
| Tmax | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Tmax is defined as the time of maximum observed blood concentration. | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
| AUC(0-T) | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to time of last quantifiable concentration. | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
| AUC(INF) | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(INF) is the area under the blood concentration-time curve from time zero extrapolated to infinite time. | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
| T-HALF | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. T-HALF is defined as the apparent terminal half-life. | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
| CLT | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. CLT is defined as the total body clearance. | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
| Vss | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Vss is defined as the volume of distribution at steady-state. | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
| Vz | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Vz is defined as the volume of distribution of the elimination phase. | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
| AUC(0-48) | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to 48 hours postdose | Cycle 1 (from time zero to 48 hours postdose) |
| AUC(0-8) | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to 8 hours postdose | Cycle 1 (from time zero to 8 hours postdose) |
| C48 | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. C48 is defined as the blood concentration at 48 hours postdose. | Cycle 1 at 48 hours postdose |
| Css-avg | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Css-avg is defined as the average blood concentration over a dosing interval at steady state (AUC[0-48]/48). | Cycle 1 (from time zero to 48 hours postdose) |
| AI_AUC | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC accumulation index; ratio of AUC(0-48) on Cycle 1 Day 19 to AUC(0-48) on Cycle 1 Day 15 for monotherapy. | Cycle 1 (Day 19, Day 15) |
| AI_Cmax | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Cmax accumulation index; ratio of Cmax on Cycle 1 Day 19 to Cmax on Cycle 1 Day 15 for monotherapy. | Cycle 1 (Day 19, Day 15) |
| T-HALFeff | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. T-HALFeff is defined as effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (exposure measure includes AUC, Cmax) | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
| Ctrough | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Ctrough is defined as the trough observed blood concentration. | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
| Number of Participants With a Positive Antibody-Drug-Antibody (ADA) Response | Baseline ADA-positive participant is defined as a participant who has an ADA-detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. Frequency distribution of baseline ADA-positive participants and ADA-positive participants after initiation of the treatment | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
| Ottawa |
| Ontario |
| K1H 8L6 |
| Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 1Z5 | Canada |
| FDA Safety Alerts and Recalls | View source |
BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277. |
| FG002 | Arm C (Part 1) | BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277. |
|
| COMPLETED | Completed = Completing the treatment period |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Part 1) | BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277. |
| BG001 | Arm B (Part 1) | BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277. |
| BG002 | Arm C (Part 1) | BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277. |
| BG003 | 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 |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| 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 an Adverse Event (AE) | Number of participants who experienced an AE during the course of the study. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Number | Number of Participants | from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months) |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Number of Participants With a Serious Adverse Event (SAE) | Number of participants who experienced a SAE during the course of the study. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Number | Number of Participants | from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With an Adverse Event (AE) Meeting Protocol-defined Dose Limiting Toxicity (DLT) Criteria | Number of participants who experienced an AE meeting protocol-defined DLT criteria during the course of the study. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Number | Number of Participants | from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With an Adverse Event (AE) Leading to Discontinuation | Number of participants who experienced an AE leading to discontinuation during the course of the study. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Number | Number of Participants | from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With an Adverse Event (AE) Leading to Death | Number of participants who experienced an AE leading to death during the course of the study. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Number | Number of Participants | from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With a Clinical Laboratory Test Abnormality | Number of participants who experienced a clinical laboratory test abnormality during the course of the study. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Number | Number of Participants | from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With a Vital Sign Abnormality or Other Safety Biomarkers | Number of participants who experienced a vital sign abnormality or other safety biomarkers during the course of the study. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Number | Number of Participants | from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR is defined as the proportion of all treated participants whose BOR is either CR or PR. BOR was determined by investigators for the reported data. Estimate of ORR and corresponding 2-sided exact 95% CI using the Clopper-Pearson method | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Number | Percentage of Participants | at Weeks 8, 16 and 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR includes complete response (CR), partial response (PR), and stable disease (SD). Estimate of DCR and corresponding 2-sided exact 95% CI using the Clopper-Pearson method | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Number | Percentage of Participants | at Weeks 8, 16 and 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Median Duration of Response (mDOR) | DOR for a participant with a 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 per RECIST v1.1/PCWG3 or death, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Number | Number of Participants | at Weeks 8, 16 and 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Median Progression-Free Survival (mPFS) | PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) for the median and Greenwood formula for the rate. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Number | Number of Participants | at Weeks 8, 16 and 24, to progression |
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| Secondary | Progression-Free Survival Rate (PFSR) | PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) for the median and Greenwood formula for the rate. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Number | Percentage of Participants | at Weeks 8, 16 and 24 |
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| Secondary | Cmax | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Cmax is defined as the maximum observed blood concentration. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
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| Secondary | Tmax | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Tmax is defined as the time of maximum observed blood concentration. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Median | Full Range | hour | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
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| Secondary | AUC(0-T) | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to time of last quantifiable concentration. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Geometric Mean | Geometric Coefficient of Variation | µg.h/mL | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
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| Secondary | AUC(INF) | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(INF) is the area under the blood concentration-time curve from time zero extrapolated to infinite time. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Geometric Mean | Geometric Coefficient of Variation | µg.h/mL | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
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| Secondary | T-HALF | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. T-HALF is defined as the apparent terminal half-life. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Mean | Standard Deviation | hour | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
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| Secondary | CLT | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. CLT is defined as the total body clearance. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Geometric Mean | Geometric Coefficient of Variation | liter | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
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| Secondary | Vss | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Vss is defined as the volume of distribution at steady-state. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Geometric Mean | Geometric Coefficient of Variation | liter | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
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| Secondary | Vz | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Vz is defined as the volume of distribution of the elimination phase. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Geometric Mean | Geometric Coefficient of Variation | liter | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
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| Secondary | AUC(0-48) | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to 48 hours postdose | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Geometric Mean | Geometric Coefficient of Variation | µg.h/mL | Cycle 1 (from time zero to 48 hours postdose) |
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| Secondary | AUC(0-8) | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to 8 hours postdose | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Geometric Mean | Geometric Coefficient of Variation | µg.h/mL | Cycle 1 (from time zero to 8 hours postdose) |
| |||||||||||||||||||||||||||||||||
| Secondary | C48 | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. C48 is defined as the blood concentration at 48 hours postdose. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Cycle 1 at 48 hours postdose |
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| Secondary | Css-avg | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Css-avg is defined as the average blood concentration over a dosing interval at steady state (AUC[0-48]/48). | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Cycle 1 (from time zero to 48 hours postdose) |
| |||||||||||||||||||||||||||||||||
| Secondary | AI_AUC | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC accumulation index; ratio of AUC(0-48) on Cycle 1 Day 19 to AUC(0-48) on Cycle 1 Day 15 for monotherapy. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio AUC(0-48),C1D19 to AUC(0-48),C1D15 | Cycle 1 (Day 19, Day 15) |
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| Secondary | AI_Cmax | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Cmax accumulation index; ratio of Cmax on Cycle 1 Day 19 to Cmax on Cycle 1 Day 15 for monotherapy. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio of Cmax,C1D19 to Cmax,C1D15 | Cycle 1 (Day 19, Day 15) |
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| Secondary | T-HALFeff | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. T-HALFeff is defined as effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (exposure measure includes AUC, Cmax) | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Median | Full Range | hour | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
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| Secondary | Ctrough | Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Ctrough is defined as the trough observed blood concentration. | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Positive Antibody-Drug-Antibody (ADA) Response | Baseline ADA-positive participant is defined as a participant who has an ADA-detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. Frequency distribution of baseline ADA-positive participants and ADA-positive participants after initiation of the treatment | All treated participants Study terminated, data not reported due to privacy reasons | Posted | Number | Number of participants | Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits |
|
AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
Not provided
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 | Arm A (Part 1) | BMS-986277 IV 3 X 10^10 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277. | 2 | 4 | 1 | 4 | 4 | 4 |
| EG001 | Arm B (Part 1) | BMS-986277 IV 3 X 10^11 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277. | 2 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Arm C (Part 1) | BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277. | 2 | 3 | 2 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Lip ulceration | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Cytokine release syndrome | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
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| Hypertonic bladder | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
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| Haematospermia | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | please email: | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2018 | Nov 20, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| 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 |
Not provided
Not provided
| <= 65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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BMS-986277 IV 1 X 10^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
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BMS-986277 IV 1 X 10^12 Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277. |
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