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)

NCT ID: NCT04817007

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-22

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myelofibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1A: BMS-986158 + Ruxolitinib

Group Type EXPERIMENTAL

BMS-986158

Intervention Type DRUG

Specified dose on specified days

Ruxolitinib

Intervention Type DRUG

Specified dose on specified days

Part 1B: BMS-986158 + Fedratinib

Group Type EXPERIMENTAL

BMS-986158

Intervention Type DRUG

Specified dose on specified days

Fedratinib

Intervention Type DRUG

Specified dose on specified days

Part 2A1: BMS-986158 + Ruxolitinib

Group Type EXPERIMENTAL

BMS-986158

Intervention Type DRUG

Specified dose on specified days

Ruxolitinib

Intervention Type DRUG

Specified dose on specified days

Part 2B1: BMS-986158 + Fedratinib

Group Type EXPERIMENTAL

BMS-986158

Intervention Type DRUG

Specified dose on specified days

Fedratinib

Intervention Type DRUG

Specified dose on specified days

Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable

Group Type EXPERIMENTAL

BMS-986158

Intervention Type DRUG

Specified dose on specified days

Fedratinib

Intervention Type DRUG

Specified dose on specified days

Part 2A2 Add-On: BMS-986158 + Ruxolitinib

Group Type EXPERIMENTAL

BMS-986158

Intervention Type DRUG

Specified dose on specified days

Ruxolitinib

Intervention Type DRUG

Specified dose on specified days

Part 2A3: BMS-986158 + Ruxolitinib

Group Type EXPERIMENTAL

BMS-986158

Intervention Type DRUG

Specified dose on specified days

Ruxolitinib

Intervention Type DRUG

Specified dose on specified days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-986158

Specified dose on specified days

Intervention Type DRUG

Ruxolitinib

Specified dose on specified days

Intervention Type DRUG

Fedratinib

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Jakafi®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution - 0069

Newport Beach, California, United States

Site Status

Local Institution - 0090

Lake Mary, Florida, United States

Site Status

Local Institution - 0043

New Orleans, Louisiana, United States

Site Status

Local Institution - 0038

Worcester, Massachusetts, United States

Site Status

Local Institution - 0033

Ann Arbor, Michigan, United States

Site Status

Local Institution - 0045

Hackensack, New Jersey, United States

Site Status

Local Institution - 0076

Chapel Hill, North Carolina, United States

Site Status

Local Institution - 0042

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0036

Blacktown, New South Wales, Australia

Site Status

Local Institution - 0032

Wollongong, New South Wales, Australia

Site Status

Local Institution - 0007

East Melbourne, Victoria, Australia

Site Status

Local Institution - 0006

Heidelberg, Victoria, Australia

Site Status

Local Institution - 0041

Nedlands, Western Australia, Australia

Site Status

Local Institution - 0015

West Perth, Western Australia, Australia

Site Status

Local Institution - 0030

Brest, , France

Site Status

Local Institution - 0008

Marseille, , France

Site Status

Local Institution - 0027

Nice, , France

Site Status

Local Institution - 0011

Paris, , France

Site Status

Local Institution - 0010

Villejuif, , France

Site Status

Local Institution - 0068

Erding, Bavaria, Germany

Site Status

Local Institution - 0039

Essen, North Rhine-Westphalia, Germany

Site Status

Local Institution - 0040

Chemnitz, Saxony, Germany

Site Status

Local Institution - 0035

Halle, Saxony-Anhalt, Germany

Site Status

Local Institution - 0050

Lübeck, Schleswig-Holstein, Germany

Site Status

Local Institution - 0061

Chaïdári, Attikí, Greece

Site Status

Local Institution - 0047

Thessaloniki, Thessaloníki, Greece

Site Status

Local Institution - 0073

Szeged, Csongrád megye, Hungary

Site Status

Local Institution - 0072

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

Site Status

Local Institution - 0075

Budapest, , Hungary

Site Status

Local Institution - 0074

Debrecen, , Hungary

Site Status

Local Institution - 0086

Beersheba, Southern District, Israel

Site Status

Local Institution - 0016

Jerusalem, , Israel

Site Status

Local Institution - 0018

Petah Tikva, , Israel

Site Status

Local Institution - 0017

Ramat Gan, , Israel

Site Status

Local Institution - 0019

Tel Aviv, , Israel

Site Status

Local Institution - 0003

Bologna, , Italy

Site Status

Local Institution - 0002

Brescia, , Italy

Site Status

Local Institution - 0001

Florence, , Italy

Site Status

Local Institution - 0012

Verona, , Italy

Site Status

Local Institution - 0077

Słupsk, Pomeranian Voivodeship, Poland

Site Status

Local Institution - 0062

Gdansk, , Poland

Site Status

Local Institution - 0052

Bucuresti, Cluj, Romania

Site Status

Local Institution - 0083

Bucharest, , Romania

Site Status

Local Institution - 0051

Cluj-Napoca, , Romania

Site Status

Local Institution - 0049

Seongnam, Kyǒnggi-do, South Korea

Site Status

Local Institution - 0048

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Local Institution - 0053

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Local Institution - 0020

Badalona, Barcelona [Barcelona], Spain

Site Status

Local Institution - 0029

Santander, Cantabria, Spain

Site Status

Local Institution - 0054

Madrid, Madrid, Comunidad de, Spain

Site Status

Local Institution - 0026

Madrid, , Spain

Site Status

Local Institution - 0021

Salamanca, , Spain

Site Status

Local Institution - 0094

Valencia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia France Germany Greece Hungary Israel Italy Poland Romania South Korea Spain

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-002071-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA011-023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.