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An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed
A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
1 other identifier
interventional
82
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2018
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2018
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedStudy Start
First participant enrolled
April 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2022
CompletedMay 23, 2022
May 1, 2022
3.9 years
February 20, 2018
May 17, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
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
Secondary Outcomes (4)
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)]
Approximately 2 years
Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)]
Approximately 2 years
Study Arms (2)
Arm A
EXPERIMENTALBMS-986299
Arm B
EXPERIMENTALBMS-986299 in combination with nivolumab and ipilimumab
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed advanced/metastatic solid tumor and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
- IO therapy resistant or insensitive tumors
- Have at least 2 tumor lesions accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
You may not qualify if:
- Primary CNS malignancy
- Participants with other active malignancy requiring concurrent intervention
- Uncontrolled or significant cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Local Institution - 0003
La Jolla, California, 92093-0698, United States
Local Institution
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
Related Publications (1)
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.
PMID: 39824531DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2018
First Posted
February 23, 2018
Study Start
April 5, 2018
Primary Completion
February 14, 2022
Study Completion
February 14, 2022
Last Updated
May 23, 2022
Record last verified: 2022-05