An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
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ClinicalTrials.gov Identifier: NCT02598960 |
Recruitment Status :
Completed
First Posted : November 6, 2015
Last Update Posted : December 21, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumors | Drug: BMS-986156 Drug: Nivolumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 331 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors |
Actual Study Start Date : | October 9, 2015 |
Actual Primary Completion Date : | December 16, 2020 |
Actual Study Completion Date : | December 16, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: BMS-986156: Dose Escalation |
Drug: BMS-986156 |
Experimental: BMS-986156 + nivolumab (nivo): Dose Escalation |
Drug: BMS-986156 Drug: Nivolumab |
Experimental: BMS-986156: Dose Expansion |
Drug: BMS-986156 |
Experimental: BMS-986156 + nivolumab (nivo): Dose Expansion |
Drug: BMS-986156 Drug: Nivolumab |
Experimental: BMS986156 + Nivo: Cohort Expansion |
Drug: BMS-986156 Drug: Nivolumab |
- Incidence of Adverse Events [ Time Frame: Up to 30 days after the last dose of study drug ]
- Incidence of Serious Adverse Events [ Time Frame: Up to 30 days after the last dose of study drug ]
- Incidence of Adverse Events leading to discontinuation [ Time Frame: Up to 30 days after the last dose of study drug ]
- Incidence of Death [ Time Frame: Up to 30 days after the last dose of study drug ]
- Incidence of Clinical Laboratory Abnormalities [ Time Frame: Up to 30 days after the last dose of study drug ]
- Objective response rate (ORR) [ Time Frame: Approximately 3 years ]
- Progression free survival rate (PFSR) [ Time Frame: At week 24 ]
- Duration of response [ Time Frame: Approximately 3 years ]
- Maximum observed concentration (Cmax) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
- Time of maximum observed concentration (Tmax) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
- Area under the concentration-time curve in one dosing interval (AUC [TAU]) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
- Anti-drug antibody (ADA) response to BMS-986156 [ Time Frame: Day 1 to 56 days ]
- Anti-drug antibody response to BMS-986156 and Nivolumab [ Time Frame: Day 1 to 56 days ]
- Best Overall Response(ORR) [ Time Frame: Approximately 3 years ]

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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:
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For Dose Escalation:
- Subjects with any previously treated advanced (metastatic or refractory) solid tumor
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For Cohort Expansion:
- Subjects must have a previously treated advanced solid tumor to be eligible
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
- Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
Exclusion Criteria:
- Known central nervous system metastases or central nervous system as the only source of disease
- Other concomitant malignancies (with some exceptions per protocol)
- Active, known or suspected autoimmune disease
- Uncontrolled or significant cardiovascular disease
- History of active or chronic hepatitis (e.g. Hep B or C)
- Impaired liver or bone marrow function
- Major surgery less than 1 month before start of the study

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): NCT02598960

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: | NCT02598960 |
Other Study ID Numbers: |
CA009-002 2015-002505-11 ( EudraCT Number ) |
First Posted: | November 6, 2015 Key Record Dates |
Last Update Posted: | December 21, 2020 |
Last Verified: | December 2020 |
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 |