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

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT04943900

Run by

Bristol-Myers Squibb

People needed

67

Starts

2021-08-09

Expected to finish

2025-02-27

Last updated by the study team

2025-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0006 — Atlanta, Georgia, United States
• Local Institution - 0005 — Baltimore, Maryland, United States
• Local Institution - 0002 — Hackensack, New Jersey, United States
• Local Institution - 0013 — Cleveland, Ohio, United States
• Local Institution - 0003 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0004 — Houston, Texas, United States
• Local Institution - 0021 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Local Institution - 0027 — ABB, Buenos Aires F.D., Argentina
• Local Institution - 0022 — CABA, Buenos Aires F.D., Argentina
• Local Institution - 0043 — Edegem, Antwerpen, Belgium
• Local Institution - 0016 — Ghent, Oost-Vlaanderen, Belgium
• Local Institution - 0009 — Edmonton, Alberta, Canada
• Local Institution - 0008 — Toronto, Ontario, Canada
• Local Institution - 0001 — Montreal, Quebec, Canada
• Local Institution - 0025 — Santiago, Santiago Metropolitan, Chile
• Local Institution - 0026 — Santiago, Santiago Metropolitan, Chile
• Local Institution - 0024 — Santiago, Santiago Metropolitan, Chile
• Local Institution - 0010 — Chuo-ku, Tokyo, Japan
• Local Institution - 0020 — Maastricht, Limburg, Netherlands

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.