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Business Objectives Have Changed
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The purpose of this study is to determine whether BMS-936559 is safe and has the desired pharmacologic activity in patients who have severe sepsis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-936559 | Experimental | BMS-936559 Intravenous infusion on specified days |
|
| Placebo | Other | Placebo on specified days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-936559 | Biological |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Safety of BMS-936559 in subjects with severe sepsis - measured by the incidence rates of death, AEs, SAEs, AEs leading to discontinuation, AEs of special interest and laboratory abnormalities | Safety will be measured by the incidence rates of death, Adverse event (AEs), Serious adverse event (SAEs), AEs leading to discontinuation, AEs of special interest (identified from PD-L1 oncology trial), and laboratory abnormalities | Approximately 3 months |
| Part 1: Tolerability of BMS-936559 in subjects with severe sepsis | Tolerability will be measured by the incidence rates of death, AEs, SAEs, AEs leading to discontinuation, AEs of special interest (identified from PD-L1 oncology trial), and laboratory abnormalities | Approximately 3 months |
| Part 2: All-cause mortality within 90 days of study drug administration | Approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) of BMS-936559 | Approximately 3 months | |
| Time of maximum observed serum concentration (Tmax) of BMS-936559 | Approximately 3 months | |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
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 |
|---|---|---|---|---|---|---|
| Uc Davis Medical Center | Sacramento | California | 95817 | United States | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30747773 | Derived | Hotchkiss RS, Colston E, Yende S, Angus DC, Moldawer LL, Crouser ED, Martin GS, Coopersmith CM, Brakenridge S, Mayr FB, Park PK, Ye J, Catlett IM, Girgis IG, Grasela DM. Immune Checkpoint Inhibition in Sepsis: A Phase 1b Randomized, Placebo-Controlled, Single Ascending Dose Study of Antiprogrammed Cell Death-Ligand 1 Antibody (BMS-936559). Crit Care Med. 2019 May;47(5):632-642. doi: 10.1097/CCM.0000000000003685. |
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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|
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-936559 |
| Approximately 3 months |
| Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-936559 | Approximately 3 months |
| Total Body Clearance (CLT) of BMS-936559 | Approximately 3 months |
| Volume of distribution at steady state (Vss) of BMS-936559 | Approximately 3 months |
| Terminal serum half-life (T-HALF) of BMS-936559 | Approximately 3 months |
| Receptor occupancy based on PD-L1 receptor occupancy levels | Approximately 3 months |
| Immune system function based on baseline and post-dosing assessments of mHLA-DR expression on monocytes at planned sampling timepoints | Approximately 3 months |
| Immune system function based on absolute lymphocyte counts at planned sampling timepoints | Approximately 3 months |
| Immune system function based on lipopolysaccharide (LPS)-induced whole blood TNFalpha production levels at planned sampling timepoints | Approximately 3 months |
| Organ dysfunction measured by organ support-free days (OSFDs) | OSFD is defined as the last period of organ support-free duration during the index hospitalization stay prior to discharge. | Approximately 3 months |
| Organ dysfunction measured by proportion of OSFDs during index hospitalization | OSFD is defined as the last period of organ support-free duration during the index hospitalization stay prior to discharge. | Approximately 3 months |
| Duration of mechanical ventilation, vasopressor use, and/or dialysis use separately during the index hospitalization | Approximately 3 months |
| Incidence of secondary infections (as adjudicated by a clinical committee) up to 90 days post administration of BMS-936559 | Approximately 3 months |
| All-cause mortality at 28 days, 90 days, and 1 year after study drug administration | All-cause mortality at 28 days, 90 days, and 1 year post administration of BMS-936559. Time to death will also be used to assess the treatment effect. | Approximately 3 months |
| Immunogenicity measured by number of subjects having detectable anti-drug antibodies (ADA) at baseline and following administration of BMS-936559. | Approximately 3 months |
| Immunogenicity measured by percentage of subjects having detectable anti-drug antibodies (ADA) at baseline and following administration of BMS-936559. | Approximately 3 months |
| Denver |
| Colorado |
| 80204 |
| United States |
| University Of Florida | Gainesville | Florida | 32610 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Osf Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| University of Michigan, Division of Acute Care Surgery | Ann Arbor | Michigan | 48109-5033 | United States |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| St. Vincent'S Medical Center | Toledo | Ohio | 43603 | United States |
| UPMC | Pittsburgh | Pennsylvania | 15261-2500 | United States |
| Local Institution | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| C000627113 | BMS-936559 |
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