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An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

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: NCT02754141
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : May 27, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

Condition or disease Intervention/treatment Phase
Malignant Solid Tumor Biological: BMS-986179 Biological: Nivolumab Biological: rHuPH20 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors
Actual Study Start Date : June 21, 2016
Actual Primary Completion Date : October 12, 2021
Actual Study Completion Date : October 12, 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: Arm A-Monotherapy
BMS-986179, dose as specified
 Biological: BMS-986179
Specified dose on specified days
Experimental: Arm B- Combination Therapy
BMS-986179 + nivolumab, dose as specified
 Biological: BMS-986179
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Arm C-Combination Therapy
BMS-986179 + rHuPH20, dose as specified
 Biological: BMS-986179
Specified dose on specified days

Biological: rHuPH20
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Number of adverse events (AE), serious adverse events (SAE), AEs leading to discontinuation, and deaths [ Time Frame: Up to 100 days after the last dose of study drug ]

Secondary Outcome Measures :
  1. The effect of BMS-986179 on CD73 enzymatic activity in pre- and on-treatment biopsies [ Time Frame: Approximately 63 days ]
  2. The effect of BMS-986179 on CD73 protein expression in pre- and on-treatment biopsies [ Time Frame: Approximately 63 days ]
  3. Objective response rate (ORR) [ Time Frame: Approximately 2 years ]
  4. Duration of response (DOR) [ Time Frame: Approximately 2 years ]
  5. Progression free survival rate (PFSR) [ Time Frame: Approximately 2 years ]
  6. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 100 days after the last dose of study drug ]
  7. Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to 100 days after the last dose of study drug ]
  8. Area under the serum concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] [ Time Frame: Up to 100 days after the last dose of study drug ]
  9. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Up to 100 days after the last dose of study drug ]
  10. Apparent terminal half-life (T-HALF) [ Time Frame: Up to 100 days after the last dose of study drug ]
  11. Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [ Time Frame: Up to 100 days after the last dose of study drug ]
  12. Effective elimination half-life (T-HALFeff) [ Time Frame: Up to 100 days after the last dose of study drug ]
  13. Concentration at the end of the dosing interval (Ctau) [ Time Frame: Up to 100 days after the last dose of study drug ]
  14. Trough observed serum concentration at the end of the dosing interval (Ctrough) [ Time Frame: Up to 100 days after the last dose of study drug ]
  15. Total body clearance (CLT) [ Time Frame: Up to 100 days after the last dose of study drug ]
  16. Volume of distribution at steady state (Vss) [ Time Frame: Up to 100 days after the last dose of study drug ]
  17. Accumulation index (AI) [ Time Frame: Up to 100 days after the last dose of study drug ]
  18. Apparent volume of distribution of terminal phase (Vz) [ Time Frame: Up to 100 days after the last dose of study drug ]
  19. Degree of fluctuation or fluctuation index (DF) [ Time Frame: Up to 100 days after the last dose of study drug ]
  20. Frequency of positive anti-drug antibody (ADA) to BMS-986179 [ Time Frame: Up to 100 days after the last dose of study drug ]
  21. Frequency of positive anti-drug antibody (ADA) to nivolumab [ Time Frame: Up to 100 days after the last dose of study drug ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective)
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Acceptable lab testing results
  • Allow biopsies

Exclusion Criteria:

  • Central nervous system (CNS) tumors
  • Uncontrolled or significant cardiovascular diseases
  • Active or known autoimmune disease
  • Organ transplant

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): NCT02754141


Locations
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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: NCT02754141    
Other Study ID Numbers: CA013-004
2016-000603-91 ( EudraCT Number )
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022

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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
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action