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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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