A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
Description
Brief Summary
The purpose of this study is to determine whether BMS-986258 both monotherapy and in
combination with Nivolumab is safe and tolerable in the treatment of advanced malignant
tumors.
Phase
N/AInclusion and Exclusion Criteria
- Histologic confirmation of one of the 5 tumors [renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1)
- 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 histologies
- Women must agree to follow specific methods of contraception, if applicable
- Active, known or suspected autoimmune disease
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
- Other active malignancy requiring concurrent intervention Other protocol-defined inclusion/exclusion criteria apply
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.