Status:
COMPLETED
A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors
Eligibility Criteria
Inclusion
- Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- 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 tumor type, if such a therapy exists
- Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
- Willing and able to comply with all study procedures
Exclusion
- Primary central nervous system (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
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2024
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT03369223
Start Date
December 6 2017
End Date
November 7 2024
Last Update
November 18 2025
Active Locations (45)
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1
Local Institution - 0005
Aurora, Colorado, United States, 80045
2
Local Institution - 0006
Denver, Colorado, United States, 80218
3
Local Institution - 0017
Miami, Florida, United States, 33176
4
Local Institution - 0024
Baltimore, Maryland, United States, 21287