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Title:
A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors (CA030-001)
Protocol Number:
J18114
Phase:
Phase I/II
Physician:
Dung Le
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
To characterize the safety, tolerability, and DLTs and to determine theMTD/RP2D of BMS-986249 administered as monotherapy and in combination with nivolumab in participants with advanced solid tumors
Eligibility:
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•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 histologiesExclusion Criteria:•Participants with primary CNS malignancies or tumors with CNS metastases as the only site of disease, will be excluded•Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted•Participants with other active malignancy requiring concurrent intervention
Treatment:
Experimental: Arm A BMS-986249Experimental: Arm B BMS-986249 in combination with nivolumab
Population:
Adult
Last Update
08/11/2020 05:02 AM