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Title:
A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination with Nivolumab in Advanced Malignant Tumors (CA043-001)
Protocol Number:
J1956
Phase:
Phase I/II
Physician:
Dung Le
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.
Eligibility:
Inclusion Criteria:•Histologic or cytologic confirmation of select 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 select solid tumor histologiesExclusion Criteria:•Participants with active, known or suspected autoimmune disease•Participants with other active malignancy requiring concurrent intervention•Participants with primary CNS malignancies or tumors with CNS metastasis as the only site of disease, will be excluded
Treatment:
Experimental: Arm A BMS-986288, Specified dose on specified days; 20, 40, 80, 160,320,480mg once every 4 weeks IV infusion. Experimental: Arm B BMS-986288 in combination with Nivolumab. BMS-986288 MTD plus Nivo 480mg once every 4 weeks IV infusion.
Population:
Adult
Last Update
08/08/2020 05:02 AM