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business objectives have changed
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The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | BMS-986299 |
|
| Arm B | Experimental | BMS-986299 in combination with nivolumab and ipilimumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986299 | Drug | Specified dose on specified day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicities (DLTs) | Up to 28 days | |
| Incidence of adverse events (AEs) | Approximately 2 years | |
| Incidence of clinical laboratory abnormalities | Approximately 2 years | |
| Incidence of serious adverse events (SAEs) | Approximately 2 years | |
| Incidence of AEs leading to discontinuation and deaths | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Approximately 2 years | |
| Time of maximum observed plasma concentration (Tmax) | Approximately 2 years | |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0003 | La Jolla | California | 92093-0698 | United States | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39824531 | Derived | Nelson BE, O'Brien S, Sheth RA, Hong DS, Naing A, Zhang X, Xu A, Hamuro L, Suryawanshi R, McKinley D, Novosiadly RD, Piha-Paul SA. Phase I study of BMS-986299, an NLRP3 agonist, as monotherapy and in combination with nivolumab and ipilimumab in patients with advanced solid tumors. J Immunother Cancer. 2025 Jan 16;13(1):e010013. doi: 10.1136/jitc-2024-010013. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| Nivolumab |
| Biological |
Specified dose on specified day |
|
|
| Ipilimumab | Biological | Specified dose on specified day |
|
|
| Approximately 2 years |
| Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)] | Approximately 2 years |
| Orange |
| California |
| 92868 |
| United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| Local Institution | New Haven | Connecticut | 06520 | United States |
| Local Institution | Detroit | Michigan | 48202 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Local Institution | Portland | Oregon | 97239 | United States |
| Local Institution | Pittsburgh | Pennsylvania | 15232-1305 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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