An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab
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ClinicalTrials.gov Identifier: NCT02754141 |
Recruitment Status :
Completed
First Posted : April 28, 2016
Last Update Posted : May 27, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malignant Solid Tumor | Biological: BMS-986179 Biological: Nivolumab Biological: rHuPH20 | Phase 1 Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A-Monotherapy
BMS-986179, dose as specified
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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:
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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 |
- 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 ]
- The effect of BMS-986179 on CD73 enzymatic activity in pre- and on-treatment biopsies [ Time Frame: Approximately 63 days ]
- The effect of BMS-986179 on CD73 protein expression in pre- and on-treatment biopsies [ Time Frame: Approximately 63 days ]
- Objective response rate (ORR) [ Time Frame: Approximately 2 years ]
- Duration of response (DOR) [ Time Frame: Approximately 2 years ]
- Progression free survival rate (PFSR) [ Time Frame: Approximately 2 years ]
- Maximum observed serum concentration (Cmax) [ Time Frame: Up to 100 days after the last dose of study drug ]
- Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to 100 days after the last dose of study drug ]
- 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 ]
- 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 ]
- Apparent terminal half-life (T-HALF) [ Time Frame: Up to 100 days after the last dose of study drug ]
- 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 ]
- Effective elimination half-life (T-HALFeff) [ Time Frame: Up to 100 days after the last dose of study drug ]
- Concentration at the end of the dosing interval (Ctau) [ Time Frame: Up to 100 days after the last dose of study drug ]
- 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 ]
- Total body clearance (CLT) [ Time Frame: Up to 100 days after the last dose of study drug ]
- Volume of distribution at steady state (Vss) [ Time Frame: Up to 100 days after the last dose of study drug ]
- Accumulation index (AI) [ Time Frame: Up to 100 days after the last dose of study drug ]
- Apparent volume of distribution of terminal phase (Vz) [ Time Frame: Up to 100 days after the last dose of study drug ]
- Degree of fluctuation or fluctuation index (DF) [ Time Frame: Up to 100 days after the last dose of study drug ]
- Frequency of positive anti-drug antibody (ADA) to BMS-986179 [ Time Frame: Up to 100 days after the last dose of study drug ]
- Frequency of positive anti-drug antibody (ADA) to nivolumab [ Time Frame: Up to 100 days after the last dose of study drug ]

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 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

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

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |