A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors

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About the study

The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid 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. Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor
  2. Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal adenocarcinoma (PDAC)
  3. Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit
  4. Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
  5. Disease amenable to serial biopsy

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Uncontrolled or significant cardiovascular disease
  2. Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome
  3. Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted)

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.
Phone iconCall 855-907-3286Email iconEmail Study Center

Study Details

Contition
Advanced Solid Tumors
Age (in years)
18+
Phase
PHASE1
Participants Needed
134
Est. Completion Date
Jun 4, 2028
Treatment Type
INTERVENTIONAL
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov NCT Identifier
NCT04943900
Study Number
CA102003

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