A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Myelofibrosis

In brief

The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone.

Key facts

Study ID

NCT04817007

Run by

Bristol-Myers Squibb

People needed

216

Starts

2021-03-22

Expected to finish

2028-08-31

Last updated by the study team

2026-05-08

Who can join

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

You may qualify if…

• Diagnosis of primary myelofibrosis (PMF), post-essential thrombocythemia (ET) or post-polycythemia vera (PV) myelofibrosis
• Treatment-related toxicities from prior therapy resolved to Grade 1 or pre-treatment baseline or determined to be irreversible prior to study treatment
• Must agree to follow specific methods of contraception, if applicable

You may not qualify if…

• Women who are pregnant or breastfeeding at screening
• Any significant acute or uncontrolled chronic medical illness
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0069 — Newport Beach, California, United States
• Local Institution - 0090 — Lake Mary, Florida, United States
• Local Institution - 0043 — New Orleans, Louisiana, United States
• Local Institution - 0038 — Worcester, Massachusetts, United States
• Local Institution - 0033 — Ann Arbor, Michigan, United States
• Local Institution - 0045 — Hackensack, New Jersey, United States
• Local Institution - 0076 — Chapel Hill, North Carolina, United States
• Local Institution - 0042 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0036 — Blacktown, New South Wales, Australia
• Local Institution - 0032 — Wollongong, New South Wales, Australia
• Local Institution - 0007 — East Melbourne, Victoria, Australia
• Local Institution - 0006 — Heidelberg, Victoria, Australia
• Local Institution - 0041 — Nedlands, Western Australia, Australia
• Local Institution - 0015 — West Perth, Western Australia, Australia
• Local Institution - 0030 — Brest, France
• Local Institution - 0008 — Marseille, France
• Local Institution - 0027 — Nice, France
• Local Institution - 0011 — Paris, France
• Local Institution - 0010 — Villejuif, France
• Local Institution - 0068 — Erding, Bavaria, Germany
• Local Institution - 0039 — Essen, North Rhine-Westphalia, Germany
• Local Institution - 0040 — Chemnitz, Saxony, Germany
• Local Institution - 0035 — Halle, Saxony-Anhalt, Germany
• Local Institution - 0050 — Lübeck, Schleswig-Holstein, Germany
• Local Institution - 0061 — Chaïdári, Attikí, Greece

Full record on ClinicalTrials.gov

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