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)

NCT04817007 · tracked via the Priya Life Science Italy tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 1/2

Started

2021-03-22

Last updated

2026-05-08

Condition(s) studied

Myelofibrosis

Investigational drug(s) / intervention(s)

BMS-986158 →Ruxolitinib →Fedratinib →

BMS-986158: Specified dose on specified days

Ruxolitinib: Specified dose on specified days

Fedratinib: Specified dose on specified days

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence of adverse events (AEs) — Up to 52 months
Incidence of serious adverse events (SAEs) — Up to 52 months
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria — Up to 26 months
Incidence of AEs leading to discontinuation — Up to 52 months
Incidence of death — Up to 52 months

Trial sites (49)

Facility	City	Region
Local Institution - 0069	Newport Beach	California
Local Institution - 0090	Lake Mary	Florida
Local Institution - 0043	New Orleans	Louisiana
Local Institution - 0038	Worcester	Massachusetts
Local Institution - 0033	Ann Arbor	Michigan
Local Institution - 0045	Hackensack	New Jersey
Local Institution - 0076	Chapel Hill	North Carolina
Local Institution - 0042	Pittsburgh	Pennsylvania
Local Institution - 0036	Blacktown	New South Wales
Local Institution - 0032	Wollongong	New South Wales
Local Institution - 0007	East Melbourne	Victoria
Local Institution - 0006	Heidelberg	Victoria
Local Institution - 0041	Nedlands	Western Australia
Local Institution - 0015	West Perth	Western 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
Local Institution - 0039	Essen	North Rhine-Westphalia
Local Institution - 0040	Chemnitz	Saxony
Local Institution - 0035	Halle	Saxony-Anhalt
Local Institution - 0050	Lübeck	Schleswig-Holstein
Local Institution - 0061	Chaïdári	Attikí
Local Institution - 0047	Thessaloniki	Thessaloníki
Local Institution - 0086	Beersheba	Southern District
Local Institution - 0016	Jerusalem	Israel
Local Institution - 0018	Petah Tikva	Israel
Local Institution - 0017	Ramat Gan	Israel
Local Institution - 0019	Tel Aviv	Israel
Local Institution - 0003	Bologna	Italy
Local Institution - 0002	Brescia	Italy
Local Institution - 0001	Florence	Italy
Local Institution - 0012	Verona	Italy
Local Institution - 0077	Słupsk	Pomeranian Voivodeship
Local Institution - 0062	Gdansk	Poland
Local Institution - 0052	Bucuresti	Cluj
Local Institution - 0083	Bucharest	Romania
Local Institution - 0051	Cluj-Napoca	Romania

+ 9 more sites — see the full list on the official registry below.

On this site

📄 Jakafi (ruxolitinib) drug profile →

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Other trials for the same condition

Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2) Active, not recruiting

Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib Recruiting

An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions Active, not recruiting

A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment Active, not recruiting

A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04817007 on ClinicalTrials.gov ↗ ← All trials in Italy