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)

May 6, 2026 updated by: Bristol-Myers Squibb

A Phase 1b/2 Study of BMS-986158 Monotherapy and in Combination With Either Ruxolitinib or Fedratinib in Participants With DIPSS-Intermediate or High Risk Myelofibrosis

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Phase 2
  • Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Local Institution - 0036
      • Wollongong, New South Wales, Australia, 2500
        • Local Institution - 0032
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Local Institution - 0007
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0006
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution - 0041
      • West Perth, Western Australia, Australia, 6005
        • Local Institution - 0015
  • France
      • Brest, France, 29200
        • Local Institution - 0030
      • Marseille, France, 13273
        • Local Institution - 0008
      • Nice, France, 06202
        • Local Institution - 0027
      • Paris, France, 75010
        • Local Institution - 0011
      • Villejuif, France, 94800
        • Local Institution - 0010
  • Germany
    • Bavaria
      • Erding, Bavaria, Germany, 85435
        • Local Institution - 0068
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45122
        • Local Institution - 0039
    • Saxony
      • Chemnitz, Saxony, Germany, 09116
        • Local Institution - 0040
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • Local Institution - 0035
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Local Institution - 0050
  • Greece
    • Attikí
      • Chaïdári, Attikí, Greece, 12462
        • Local Institution - 0061
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Greece, 570 10
        • Local Institution - 0047
  • Israel
      • Jerusalem, Israel, 9112001
        • Local Institution - 0016
      • Petah Tikva, Israel, 4910021
        • Local Institution - 0018
      • Ramat Gan, Israel, 5262100
        • Local Institution - 0017
      • Tel Aviv, Israel, 6423906
        • Local Institution - 0019
    • Southern District
      • Beersheba, Southern District, Israel, 8410101
        • Local Institution - 0086
  • Italy
      • Bologna, Italy, 40138
        • Local Institution - 0003
      • Brescia, Italy, 25123
        • Local Institution - 0002
      • Florence, Italy, 50134
        • Local Institution - 0001
      • Verona, Italy, 37134
        • Local Institution - 0012
  • Poland
      • Gdansk, Poland, 80-952
        • Local Institution - 0062
    • Pomeranian Voivodeship
      • Słupsk, Pomeranian Voivodeship, Poland, 76-200
        • Local Institution - 0077
  • Romania
      • Bucharest, Romania, 050098
        • Local Institution - 0083
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0051
    • Cluj
      • Bucuresti, Cluj, Romania, 022328
        • Local Institution - 0052
  • South Korea
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, South Korea, 13620
        • Local Institution - 0049
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
        • Local Institution - 0048
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06591
        • Local Institution - 0053
  • Spain
      • Madrid, Spain, 28041
        • Local Institution - 0026
      • Salamanca, Spain, 37007
        • Local Institution - 0021
      • Valencia, Spain, 46026
        • Local Institution - 0094
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Local Institution - 0020
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Local Institution - 0029
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Local Institution - 0054
  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Local Institution - 0069
    • Florida
      • Lake Mary, Florida, United States, 32746
        • Local Institution - 0090
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Local Institution - 0043
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Local Institution - 0038
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution - 0033
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0045
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Local Institution - 0076
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Local Institution - 0042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1A: BMS-986158 + Ruxolitinib
Drug: BMS-986158
Specified dose on specified days
Drug: Ruxolitinib
Specified dose on specified days
Other Names:
  • Jakafi®
Experimental: Part 1B: BMS-986158 + Fedratinib
Drug: BMS-986158
Specified dose on specified days
Drug: Fedratinib
Specified dose on specified days
Experimental: Part 2A1: BMS-986158 + Ruxolitinib
Drug: BMS-986158
Specified dose on specified days
Drug: Ruxolitinib
Specified dose on specified days
Other Names:
  • Jakafi®
Experimental: Part 2B1: BMS-986158 + Fedratinib
Drug: BMS-986158
Specified dose on specified days
Drug: Fedratinib
Specified dose on specified days
Experimental: Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable
Drug: BMS-986158
Specified dose on specified days
Drug: Fedratinib
Specified dose on specified days
Experimental: Part 2A2 Add-On: BMS-986158 + Ruxolitinib
Drug: BMS-986158
Specified dose on specified days
Drug: Ruxolitinib
Specified dose on specified days
Other Names:
  • Jakafi®
Experimental: Part 2A3: BMS-986158 + Ruxolitinib
Drug: BMS-986158
Specified dose on specified days
Drug: Ruxolitinib
Specified dose on specified days
Other Names:
  • Jakafi®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate defined as proportion of participants with SVR ≥ 35% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR
Time Frame: Up to 175 days
Up to 175 days
Response rate defined as proportion of participants with SVR ≥ 25% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR
Time Frame: Up to 175 days
Up to 175 days
Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF)
Time Frame: Up to 175 days
Up to 175 days
Additional measures based on TSS measured by MFSAF
Time Frame: Up to 175 days
Up to 175 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2021

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA011-023
  • 2023-509635-89 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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