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An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

Trial Status: Active

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.

Inclusion 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

Exclusion Criteria

  • 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


Los Angeles
Los Angeles County-USC Medical Center
Contact: Xiomara Menendez
Phone: 323-865-0212
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Lorraine Martinez
Phone: 323-865-0967
Newport Beach
Hoag Memorial Hospital
Status: ACTIVE
Contact: Cristina de Leon
Phone: 949-764-5543


University of Colorado Hospital
Status: ACTIVE


Iowa City
University of Iowa / Holden Comprehensive Cancer Center

New Hampshire

Dartmouth Hitchcock Medical Center


University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

  • Primary ID CA031-002
  • Secondary IDs NCI-2018-00467, 2019-000442-35
  • ID NCT03446040