MyelofibrosisPhase 1/2NCT04817007
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)
A Phase 1/2 study testing BMS-986158, Ruxolitinib and Fedratinib in people with Myelofibrosis, run by Bristol-Myers Squibb at 49 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- BMS-986158, Ruxolitinib and Fedratinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 49 sitesin 11 countries
- Study dates
- 22 Mar 2021to 31 Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women who are pregnant or breastfeeding at screening
- Any significant acute or uncontrolled chronic medical illness
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
49 sites in 11 countries.
49 sites in 11 countries
United States8 sites
Local Institution - 0033
Ann Arbor, Michigan, 48109
Local Institution - 0076
Chapel Hill, North Carolina, 27514
Local Institution - 0045
Hackensack, New Jersey, 07601
Local Institution - 0090
Lake Mary, Florida, 32746
Local Institution - 0043
New Orleans, Louisiana, 70112
Local Institution - 0069
Newport Beach, California, 92663
Local Institution - 0042
Pittsburgh, Pennsylvania, 15224
Local Institution - 0038
Worcester, Massachusetts, 01655
Australia6 sites
Local Institution - 0036
Blacktown, New South Wales, 2148
Local Institution - 0007
East Melbourne, Victoria, 3002
Local Institution - 0006
Heidelberg, Victoria, 3084
Local Institution - 0041
Nedlands, Western Australia, 6009
Local Institution - 0015
West Perth, Western Australia, 6005
Local Institution - 0032
Wollongong, New South Wales, 2500
Spain6 sites
Local Institution - 0020
Badalona, Barcelona [Barcelona], 08916
Local Institution - 0054
Madrid, Madrid, Comunidad de, 28034
Local Institution - 0026
Madrid, 28041
Local Institution - 0021
Salamanca, 37007
Local Institution - 0029
Santander, Cantabria, 39008
Local Institution - 0094
Valencia, 46026
France5 sites
Local Institution - 0030
Brest, 29200
Local Institution - 0008
Marseille, 13273
Local Institution - 0027
Nice, 06202
Local Institution - 0011
Paris, 75010
Local Institution - 0010
Villejuif, 94800
Germany5 sites
Local Institution - 0040
Chemnitz, Saxony, 09116
Local Institution - 0068
Erding, Bavaria, 85435
Local Institution - 0039
Essen, North Rhine-Westphalia, 45122
Local Institution - 0035
Halle, Saxony-Anhalt, 06120
Local Institution - 0050
Lübeck, Schleswig-Holstein, 23538
Israel5 sites
Local Institution - 0086
Beersheba, Southern District, 8410101
Local Institution - 0016
Jerusalem, 9112001
Local Institution - 0018
Petah Tikva, 4910021
Local Institution - 0017
Ramat Gan, 5262100
Local Institution - 0019
Tel Aviv, 6423906
Italy4 sites
Local Institution - 0003
Bologna, 40138
Local Institution - 0002
Brescia, 25123
Local Institution - 0001
Florence, 50134
Local Institution - 0012
Verona, 37134
Romania3 sites
Local Institution - 0083
Bucharest, 050098
Local Institution - 0052
Bucuresti, Cluj, 022328
Local Institution - 0051
Cluj-Napoca, 400015
South Korea3 sites
Local Institution - 0049
Seongnam, Kyǒnggi-do, 13620
Local Institution - 0048
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Local Institution - 0053
Seoul, Seoul-teukbyeolsi [Seoul], 06591
Greece2 sites
Local Institution - 0061
Chaïdári, Attikí, 12462
Local Institution - 0047
Thessaloniki, Thessaloníki, 570 10
Poland2 sites
Local Institution - 0062
Gdansk, 80-952
Local Institution - 0077
Słupsk, Pomeranian Voivodeship, 76-200
About this study
Official title: 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.
- Conditions
- Myelofibrosis
- Being tested
- BMS-986158, Ruxolitinib, Fedratinib
- Keywords
- BMS-986158, Fedratinib, Myelofibrosis, Ruxolitinib
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986158Drug
Specified dose on specified days
RuxolitinibDrug
Also called Jakafi®
Specified dose on specified days
FedratinibDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: BMS-986158 + Ruxolitinib | Experimental | Not described Receives: Drug: BMS-986158; Drug: Ruxolitinib |
| Part 1B: BMS-986158 + Fedratinib | Experimental | Not described Receives: Drug: BMS-986158; Drug: Fedratinib |
| Part 2A1: BMS-986158 + Ruxolitinib | Experimental | Not described Receives: Drug: BMS-986158; Drug: Ruxolitinib |
| Part 2B1: BMS-986158 + Fedratinib | Experimental | Not described Receives: Drug: BMS-986158; Drug: Fedratinib |
| Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable | Experimental | Not described Receives: Drug: BMS-986158; Drug: Fedratinib |
| Part 2A2 Add-On: BMS-986158 + Ruxolitinib | Experimental | Not described Receives: Drug: BMS-986158; Drug: Ruxolitinib |
| Part 2A3: BMS-986158 + Ruxolitinib | Experimental | Not described Receives: Drug: BMS-986158; Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Up to 52 months
Incidence of serious adverse events (SAEs)
Measured: Up to 52 months
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Measured: Up to 26 months
Incidence of AEs leading to discontinuation
Measured: Up to 52 months
Incidence of death
Measured: Up to 52 months
Secondary outcomes (4)
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
Measured: 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
Measured: Up to 175 days
Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF)
Measured: Up to 175 days
Additional measures based on TSS measured by MFSAF
Measured: Up to 175 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start22 Mar 2021
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817007
- Sponsor's protocol ID
- CA011-023
- Other IDs
- 2023-509635-89, 2023
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04817007
- Acronym / sponsor ID
- CA011-023
- Conditions
- Myelofibrosis
- Keywords
- BMS-986158, Fedratinib, Myelofibrosis, Ruxolitinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1A: BMS-986158 + Ruxolitinib | Experimental | Drug: BMS-986158, Drug: Ruxolitinib |
| Part 1B: BMS-986158 + Fedratinib | Experimental | Drug: BMS-986158, Drug: Fedratinib |
| Part 2A1: BMS-986158 + Ruxolitinib | Experimental | Drug: BMS-986158, Drug: Ruxolitinib |
| Part 2B1: BMS-986158 + Fedratinib | Experimental | Drug: BMS-986158, Drug: Fedratinib |
| Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable | Experimental | Drug: BMS-986158, Drug: Fedratinib |
| Part 2A2 Add-On: BMS-986158 + Ruxolitinib | Experimental | Drug: BMS-986158, Drug: Ruxolitinib |
| Part 2A3: BMS-986158 + Ruxolitinib | Experimental | Drug: BMS-986158, Drug: Ruxolitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Women who are pregnant or breastfeeding at screening
- Any significant acute or uncontrolled chronic medical illness
- Other protocol-defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986158Specified dose on specified days | Drug | Part 1A: BMS-986158 + Ruxolitinib, Part 1B: BMS-986158 + Fedratinib, Part 2A1: BMS-986158 + Ruxolitinib, Part 2A2 Add-On: BMS-986158 + Ruxolitinib, Part 2A3: BMS-986158 + Ruxolitinib, Part 2B1: BMS-986158 + Fedratinib, Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable |
| RuxolitinibAlso: Jakafi®Specified dose on specified days | Drug | Part 1A: BMS-986158 + Ruxolitinib, Part 2A1: BMS-986158 + Ruxolitinib, Part 2A2 Add-On: BMS-986158 + Ruxolitinib, Part 2A3: BMS-986158 + Ruxolitinib |
| FedratinibSpecified dose on specified days | Drug | Part 1B: BMS-986158 + Fedratinib, Part 2B1: BMS-986158 + Fedratinib, Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to 52 months
Incidence of serious adverse events (SAEs)
Time frame: Up to 52 months
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time frame: Up to 26 months
Incidence of AEs leading to discontinuation
Time frame: Up to 52 months
Incidence of death
Time frame: Up to 52 months
4 secondary outcomes
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
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
Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF)
Time frame: Up to 175 days
Additional measures based on TSS measured by MFSAF
Time frame: Up to 175 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
49 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-986158, Ruxolitinib and Fedratinib in people with Myelofibrosis, run by Bristol-Myers Squibb at 49 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Australia, Spain, France, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Up to 52 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.