Safety, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Severe Sepsis
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ClinicalTrials.gov Identifier: NCT02576457 |
Recruitment Status :
Terminated
(Business Objectives Have Changed)
First Posted : October 15, 2015
Last Update Posted : September 15, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Severe Sepsis Septic Shock | Biological: BMS-936559 Other: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b/2a, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Subjects With Severe Sepsis |
Actual Study Start Date : | December 2, 2015 |
Actual Primary Completion Date : | March 15, 2017 |
Actual Study Completion Date : | March 15, 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: BMS-936559
BMS-936559 Intravenous infusion on specified days
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Biological: BMS-936559 |
Placebo
Placebo on specified days
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Other: Placebo |
- 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 [ Time Frame: Approximately 3 months ]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
- Part 1: Tolerability of BMS-936559 in subjects with severe sepsis [ Time Frame: Approximately 3 months ]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
- Part 2: All-cause mortality within 90 days of study drug administration [ Time Frame: Approximately 3 months ]
- Maximum observed serum concentration (Cmax) of BMS-936559 [ Time Frame: Approximately 3 months ]
- Time of maximum observed serum concentration (Tmax) of BMS-936559 [ Time Frame: Approximately 3 months ]
- Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-936559 [ Time Frame: Approximately 3 months ]
- Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-936559 [ Time Frame: Approximately 3 months ]
- Total Body Clearance (CLT) of BMS-936559 [ Time Frame: Approximately 3 months ]
- Volume of distribution at steady state (Vss) of BMS-936559 [ Time Frame: Approximately 3 months ]
- Terminal serum half-life (T-HALF) of BMS-936559 [ Time Frame: Approximately 3 months ]
- Receptor occupancy based on PD-L1 receptor occupancy levels [ Time Frame: Approximately 3 months ]
- Immune system function based on baseline and post-dosing assessments of mHLA-DR expression on monocytes at planned sampling timepoints [ Time Frame: Approximately 3 months ]
- Immune system function based on absolute lymphocyte counts at planned sampling timepoints [ Time Frame: Approximately 3 months ]
- Immune system function based on lipopolysaccharide (LPS)-induced whole blood TNFalpha production levels at planned sampling timepoints [ Time Frame: Approximately 3 months ]
- Organ dysfunction measured by organ support-free days (OSFDs) [ Time Frame: Approximately 3 months ]OSFD is defined as the last period of organ support-free duration during the index hospitalization stay prior to discharge.
- Organ dysfunction measured by proportion of OSFDs during index hospitalization [ Time Frame: Approximately 3 months ]OSFD is defined as the last period of organ support-free duration during the index hospitalization stay prior to discharge.
- Duration of mechanical ventilation, vasopressor use, and/or dialysis use separately during the index hospitalization [ Time Frame: Approximately 3 months ]
- Incidence of secondary infections (as adjudicated by a clinical committee) up to 90 days post administration of BMS-936559 [ Time Frame: Approximately 3 months ]
- All-cause mortality at 28 days, 90 days, and 1 year after study drug administration [ Time Frame: Approximately 3 months ]
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.
- Immunogenicity measured by number of subjects having detectable anti-drug antibodies (ADA) at baseline and following administration of BMS-936559. [ Time Frame: Approximately 3 months ]
- Immunogenicity measured by percentage of subjects having detectable anti-drug antibodies (ADA) at baseline and following administration of BMS-936559. [ Time Frame: Approximately 3 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Severe sepsis or septic shock for at least 24 hours
- Documented or suspected infection
- Sepsis-induced immunosuppression
- Men and women ≥ 18 years old
Exclusion Criteria:
- Autoimmune disease
- Organ transplant or bone marrow transplant
- Cancer treated in the past 6 months
- Hepatitis B virus (HBV) Infection
- Human Immunodeficiency Virus (HIV) infection and not on therapy prior to this episode of sepsis
- Hepatitis C virus (HCV) infection and still has virus (not cured)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576457
United States, California | |
Uc Davis Medical Center | |
Sacramento, California, United States, 95817 | |
United States, Colorado | |
Local Institution | |
Denver, Colorado, United States, 80204 | |
United States, Florida | |
University Of Florida | |
Gainesville, Florida, United States, 32610 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Osf Saint Francis Medical Center | |
Peoria, Illinois, United States, 61637 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Baystate Medical Center | |
Springfield, Massachusetts, United States, 01199 | |
United States, Michigan | |
University of Michigan, Division of Acute Care Surgery | |
Ann Arbor, Michigan, United States, 48109-5033 | |
United States, Missouri | |
Washington University School Of Medicine | |
Saint Louis, Missouri, United States, 63110 | |
United States, Ohio | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 | |
St. Vincent'S Medical Center | |
Toledo, Ohio, United States, 43603 | |
United States, Pennsylvania | |
UPMC | |
Pittsburgh, Pennsylvania, United States, 15261-2500 | |
United States, Washington | |
Local Institution | |
Seattle, Washington, United States, 98104 |
Study Director: | Bristol Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02576457 |
Other Study ID Numbers: |
AI471-049 |
First Posted: | October 15, 2015 Key Record Dates |
Last Update Posted: | September 15, 2017 |
Last Verified: | September 2017 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Sepsis Toxemia Infections Systemic Inflammatory Response Syndrome Inflammation |
Pathologic Processes BMS-936559 Antineoplastic Agents, Immunological Antineoplastic Agents |