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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. 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)
  2. Eastern Cooperative Oncology Group Performance Status of 0 or 1
  3. 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
  4. Women must agree to follow specific methods of contraception, if applicable

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Active, known or suspected autoimmune disease
  2. Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
  3. Other active malignancy requiring concurrent intervention

Other protocol-defined inclusion/exclusion criteria apply


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study Details

Contition
Advanced Cancer
Age (in years)
18+
Phase
PHASE1/PHASE2
Participants Needed
92
Est. Completion Date
Aug 29, 2024
Treatment Type
INTERVENTIONAL
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov NCT Identifier
NCT03446040
Study Number
CA031002

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