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

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.

Who can take part

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

INCLUSION CRITERIA

Inclusion Criteria:

Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor
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)
Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit
Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
Disease amenable to serial biopsy

EXCLUSION CRITERIA

Exclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria apply

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’s details

Contition

Advanced Solid Tumors

Age (in years)

18+

Phase

Phase 1

Participants needed

134

Est. Completion Date

Jun 4, 2028

Treatment type

Interventional

Sponsor

Bristol-Myers Squibb

ClinicalTrials.gov identifier

NCT04943900

Study number

CA102003

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