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Study of BMS-986158 in Subjects With Select Advanced Cancers (BET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02419417
Recruitment Status : Active, not recruiting
First Posted : April 17, 2015
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986158 in subjects with select advanced cancers

Condition or disease Intervention/treatment Phase
Advanced Tumors Drug: BMS-986158 Biological: Nivolumab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 417 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, as Monotherapy or in Combination With Nivolumab in Subjects With Selected Advanced Solid Tumors or Hematologic Malignancies
Actual Study Start Date : June 19, 2015
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 2, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Monotherapy Treatment
Patients treated at various doses and schedules
 Drug: BMS-986158
Specified dose on specified days
Experimental: Combination Therapy
Patients treated at selected doses and schdules
 Drug: BMS-986158
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo


Outcome Measures
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Primary Outcome Measures :
  1. Number of Adverse Events (AEs) [ Time Frame: Up to 4 years ]
  2. Number of Serious Adverse Events (SAEs) [ Time Frame: Up to 4 years ]
  3. Number of AEs leading to discontinuation [ Time Frame: Up to 4 years ]
  4. Number of laboratory test toxicity grade shifting from baseline [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  1. Best Overall Response [ Time Frame: Up to 4 years ]
  2. Objective Response Rate (ORR) [ Time Frame: Up to 4 years ]
  3. Duration of Response [ Time Frame: Up to 4 years ]
  4. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 4 years ]
  5. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to 4 years ]
  6. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) [ Time Frame: Up to 4 years ]
  7. Area under the concentration-time curve in one dosing interval (AUC(TAU)) [ Time Frame: Up to 4 years ]
  8. Apparent terminal phase half-life (T-HALF) [ Time Frame: Up to 4 years ]
  9. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [ Time Frame: Up to 4 years ]
  10. Apparent total body clearance, reported only for parent, not for metabolite (CLT/F) [ Time Frame: Up to 4 years ]
  11. Apparent volume of distribution of terminal phase, reported only for parent, not for metabolite (Vz/F) [ Time Frame: Up to 4 years ]
  12. Minimum observed concentration within a dosing interval (Cmin) [ Time Frame: Up to 4 years ]
  13. Concentration at the end of a dosing interval (Ctau) [ Time Frame: Up to 4 years ]
  14. Trough observed plasma concentration (this includes predose concentrations (C0) and concentrations at the end of dosing interval (Ctau)) (Ctrough) [ Time Frame: Up to 4 years ]
  15. Degree of Fluctuation or Fluctuation Index ([Cmax-Cmin)/Css-avg]) [ Time Frame: Up to 4 years ]
  16. [Cmax - Cmin] / Cmin; to be calculated at steady-state (Swing) [ Time Frame: Up to 4 years ]
  17. Accumulation Index (AI) [ Time Frame: Up to 4 years ]
    Ratio of an exposure measure at steady-state to that after the first dose (exposure measure includes AUC(TAU), Cmax and Ctau)

  18. Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALFeff) [ Time Frame: Up to 4 years ]
  19. Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) [ Time Frame: Up to 4 years ]
  20. Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight (MR_AUC(0-T)) [ Time Frame: Up to 4 years ]
  21. Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight (following single dose only) (MR_AUC(INF)) [ Time Frame: Up to 4 years ]
  22. Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight (MR_AUC(TAU)) [ Time Frame: Up to 4 years ]
  23. Electrocardiogram (ECG) QT (time of ventricular activity including both depolarization and repolarization) Interval [ Time Frame: Up to 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Must have select advanced cancers with specific genetic profiles
  • Must have received appropriate standard of care
  • At least one measurable lesion at baseline
  • Expected to have life expectancy of at least 3 months
  • Eastern Cooperative Oncology Group (ECOG) of 0 to 1

Exclusion Criteria:

  • Concomitant second malignancies
  • Uncontrolled or significant cardiovascular disease
  • Inadequate bone marrow function
  • Chronic gastrointestinal illness
  • Prior treatment with Bromodomain and Extra-Terminal (BET) inhibitor

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations
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Information from the National Library of Medicine

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): NCT02419417


Locations
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United States, California
City Of Hope National Medical Center
Duarte, California, United States, 91010
United States, Colorado
University Of Colorado
Aurora, Colorado, United States, 80045
United States, Massachusetts
Dana Farber Cancer Institute.
Boston, Massachusetts, United States, 02215
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Univ. Of Pa
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Institute for Translational Oncology Research-ITOR
Greenville, South Carolina, United States, 29605
Australia, Victoria
Nucleus Network
Melbourne, Victoria, Australia, 3004
Canada, Ontario
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
France
Local Institution
Lyon Cedex 08, France, 69373
Local Institution
Villejuif, France, 94800
Spain
H. Univ. Vall dHebron
Barcelona, Spain, 08035
Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02419417    
Other Study ID Numbers: CA011-001
2015-000324-29 ( EudraCT Number )
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents