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

• Status: Not yet recruiting
• Trial end date: 2023-11-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Nivolumab

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit:

www.BMSStudyConnect.com

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