An Investigational Immunotherapy Study of BMS-986249 Alone and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread
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ClinicalTrials.gov Identifier: NCT03369223 |
Recruitment Status :
Recruiting
First Posted : December 11, 2017
Last Update Posted : April 9, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Cancer | Biological: BMS-986249 Biological: Nivolumab Biological: Ipilimumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 425 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors |
Actual Study Start Date : | December 6, 2017 |
Estimated Primary Completion Date : | September 17, 2024 |
Estimated Study Completion Date : | September 18, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Part 1A: BMS-986249 |
Biological: BMS-986249
specified dose on specified day |
Experimental: Part 1B: BMS-986249 + nivolumab (nivo) |
Biological: BMS-986249
specified dose on specified day Biological: Nivolumab Specified dose on specified days
Other Names:
|
Experimental: Part 2A Arm C: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
|
Biological: BMS-986249
specified dose on specified day Biological: Nivolumab Specified dose on specified days
Other Names:
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Experimental: Part 2A Arm D: ipilimumab + nivo then nivo
Previously untreated unresectable stage III-IV melanoma
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Ipilimumab Specified dose on specified days
Other Names:
|
Experimental: Part 2A Arm F: BMS-986249 + nivo
Previously untreated unresectable stage III-IV melanoma
|
Biological: BMS-986249
specified dose on specified day Biological: Nivolumab Specified dose on specified days
Other Names:
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Experimental: Part 2B Cohort 1: BMS-986249 + nivo
Advanced hepatocellular carcinoma (HCC)
|
Biological: BMS-986249
specified dose on specified day Biological: Nivolumab Specified dose on specified days
Other Names:
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Experimental: Part 2B Cohort 2: BMS-986249 + nivo
Metastatic castration-resistant prostate cancer (CRPC)
|
Biological: BMS-986249
specified dose on specified day Biological: Nivolumab Specified dose on specified days
Other Names:
|
Experimental: Part 2B Cohort 3: BMS-986249 + nivo
Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
|
Biological: BMS-986249
specified dose on specified day Biological: Nivolumab Specified dose on specified days
Other Names:
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Experimental: Part 2A Arm A: BMS-986249 + nivo then nivo
|
Biological: BMS-986249
specified dose on specified day Biological: Nivolumab Specified dose on specified days
Other Names:
|
Experimental: Part 2A Arm B: BMS-986249 + nivo
|
Biological: BMS-986249
specified dose on specified day Biological: Nivolumab Specified dose on specified days
Other Names:
|
Experimental: Part 2A Arm E: Nivo
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
|
- Incidence of Adverse Events (AEs) [ Time Frame: Up to 2.5 years ]
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 2.5 years ]
- Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 2.5 years ]
- Incidence of AEs leading to discontinuation [ Time Frame: Up to 2.5 years ]
- Incidence of death [ Time Frame: Up to 4 years ]
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 2.5 years ]
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 2.5 years ]
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 2.5 years ]
- Incidence of treatment-related Grade 3-5 AEs [ Time Frame: Within 24 weeks ]
- Objective Response Rate as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 2.5 years ]
- Cmax (Maximum observed serum concentration) [ Time Frame: Up to 2 years ]
- Tmax (Time of maximum observed concentration) [ Time Frame: Up to 2 years ]
- AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration) [ Time Frame: Up to 2 years ]
- AUC(TAU) (Area under the concentration-time curve in 1 dosing interval) [ Time Frame: Up to 2 years ]
- Ctau (Observed concentration at the end of a dosing interval) [ Time Frame: Up to 2 years ]
- Ctrough (Trough observed concentrations) [ Time Frame: Up to 2 years ]
- Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) [ Time Frame: Up to 2 years ]
- Terminal serum half-life if data permit (T-HALF) [ Time Frame: Up to 2 years ]
- Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)] [ Time Frame: Up to 2 years ]
- Total body clearance (CLT) [ Time Frame: Up to 2 years ]
- Objective Response Rate (ORR) [ Time Frame: Up to 4 years ]
- Duration of response (DOR) [ Time Frame: Up to 4 years ]
- Progression-Free survival (PFS) [ Time Frame: Up to 4 years ]
- Time to response (TTR) [ Time Frame: Up to 4 years ]
- Incidence of Adverse Events (AEs) in Part 2 of Study [ Time Frame: Up to 2.5 years ]
- Incidence of Serious Adverse Events (SAEs) in Part 2 of Study [ Time Frame: Up to 2.5 years ]
- Incidence of AEs leading to discontinuation in Part 2 of study [ Time Frame: Up to 2.5 years ]
- Incidence of death in Part 2 of study [ Time Frame: Up to 4 years ]
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests in Part 2 of study [ Time Frame: Up to 2.5 years ]
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests in Part 2 of study [ Time Frame: Up to 2.5 years ]
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests in Part 2 of study [ Time Frame: Up to 2.5 years ]
- Time to Deterioration (TTD) in Part 2 of study [ Time Frame: Up to 4 Years ]

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:
- Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Some participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies
- Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
- Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation
- Willing and able to comply with all study procedures
Exclusion Criteria:
- Primary CNS malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded
- Other active malignancy requiring concurrent intervention
- Prior organ allograft
- Active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria 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): NCT03369223
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information | please email: | Clinical.Trials@bms.com | |
Contact: First line of the email MUST contain NCT # and Site #. |

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT03369223 |
Other Study ID Numbers: |
CA030-001 2018-000416-21 ( EudraCT Number ) |
First Posted: | December 11, 2017 Key Record Dates |
Last Update Posted: | April 9, 2021 |
Last Verified: | April 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Antibodies Antineoplastic Agents Immunologic Factors |
Nivolumab Antibodies, Monoclonal Physiological Effects of Drugs |
Nivolumab Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents |