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

A Phase 1 Study of BMS-986416 Alone and in Combination With Nivolumab in Select Solid Tumors

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.

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:

• 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