A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Cancer, Melanoma

In brief

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

Key facts

Study ID

NCT03400332

Run by

Bristol-Myers Squibb

People needed

281

Starts

2018-02-12

Expected to finish

2025-12-04

Last updated by the study team

2026-02-24

Who can join

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

You may qualify if…

• Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
• At least 1 lesion accessible for biopsy
• Eastern Cooperative Oncology Group Performance Status of 0 or 1

You may not qualify if…

• Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
• Participants with active, known or suspected autoimmune disease
• Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
• Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
• Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
• Other protocol defined inclusion/exclusion criteria could apply

Where it is running

• Local Institution - 0099 — Los Angeles, California, United States
• Local Institution - 0007 — Lakewood, Colorado, United States
• Local Institution - 0087 — Atlanta, Georgia, United States
• Local Institution - 0100 — Atlanta, Georgia, United States
• Local Institution - 0101 — Marietta, Georgia, United States
• Local Institution - 0012 — Columbia, Maryland, United States
• Local Institution - 0003 — Lutherville, Maryland, United States
• Local Institution - 0060 — Boston, Massachusetts, United States
• Local Institution - 0004 — Ann Arbor, Michigan, United States
• Local Institution - 0076 — Omaha, Nebraska, United States
• Comprehensive Cancer Centers Of Nevada — Las Vegas, Nevada, United States
• Local Institution - 0005 — Hackensack, New Jersey, United States
• Local Institution - 0032 — New Brunswick, New Jersey, United States
• Local Institution - 0025 — New York, New York, United States
• Local Institution - 0002 — New York, New York, United States
• Local Institution - 0028 — Oklahoma City, Oklahoma, United States
• Local Institution - 0017 — Eugene, Oregon, United States
• Local Institution - 0001 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0009 — Greenville, South Carolina, United States
• Local Institution - 0011 — Austin, Texas, United States
• Local Institution - 0010 — Dallas, Texas, United States
• Local Institution - 0014 — Fort Worth, Texas, United States
• Local Institution - 0018 — Houston, Texas, United States
• Local Institution - 0006 — San Antonio, Texas, United States
• Local Institution - 0059 — Springdale, Arkansas, United States

Full record on ClinicalTrials.gov

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