Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study of BMS-986158 Alone and with Ruxolitinib or Fedratinib for Patients with Intermediate or High Risk Myelofibrosis

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called myelofibrosis, which is a type of blood cancer that affects the bone marrow. The study is specifically looking at patients with intermediate or high risk of this disease. The trial will test a new treatment approach using a medication known as BMS-986158, both on its own and in combination with other medications called Ruxolitinib and Fedratinib. These medications are taken orally, meaning they are swallowed in the form of tablets or capsules.

The purpose of the study is to assess the safety and tolerability of these treatments. The study will be conducted in two parts. In the first part, the focus will be on finding the right dose of BMS-986158 when used with Ruxolitinib or Fedratinib. In the second part, the study will further explore the safety of these combinations and also test BMS-986158 as a standalone treatment. Participants will be monitored for any side effects and how well they tolerate the medications.

Throughout the study, participants will undergo regular assessments, including imaging tests like MRI or computed tomography (CT) scans, to measure changes in their condition. The study aims to provide valuable information on how these treatments can be used to manage myelofibrosis, potentially offering new options for patients with this challenging disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A series of tests, such as blood tests and imaging scans, will be performed to assess the current health status and the size of the spleen.

  2. Step 2

    Treatment allocation

    Participants will be assigned to one of the treatment groups. The treatment may involve BMS-986158 alone or in combination with either ruxolitinib or fedratinib.

    The specific treatment plan will depend on previous exposure to certain medications and the current health condition.

  3. Step 3

    Medication administration

    The medications will be administered orally in the form of tablets or capsules.

    The dosage and frequency will be determined by the study protocol and may vary depending on the treatment group.

  4. Step 4

    Regular monitoring

    Regular visits to the study site will be required for monitoring. This includes physical examinations, blood tests, and imaging scans to assess the response to treatment.

    Participants will be monitored for any side effects or adverse reactions to the medication.

  5. Step 5

    Dose adjustment

    Based on the response to treatment and any side effects experienced, the dosage of the medication may be adjusted.

    The study team will provide guidance on any changes to the treatment plan.

  6. Step 6

    End of treatment evaluation

    At the end of the treatment period, a final evaluation will be conducted. This includes a comprehensive assessment of health status and the effectiveness of the treatment.

    Participants will be informed about the results and any further steps that may be necessary.

Who can join the trial?

9 criteria

  • Must be a male or female who is at least 18 years old.
  • Must have a diagnosis of Myelofibrosis (MF), which is a type of blood cancer, according to specific medical criteria.
  • Must have a DIPSS Risk Score of Intermediate-1 with symptoms, Intermediate-2, or High. DIPSS is a system used to determine the risk level of the disease.
  • Must have a measurable enlarged spleen during the screening period, as shown by a specific type of scan (MRI or CT scan).
  • Must have an ECOG Performance Status of 2 or less. This is a scale used to assess how the disease affects daily living abilities, with lower numbers indicating better function.
  • For certain parts of the study, must not have been treated with JAK2 inhibitors before starting the study treatment. JAK2 inhibitors are a type of medication used to treat MF.
  • For other parts of the study, must have been treated with ruxolitinib (a JAK2 inhibitor) for at least 3 to 6 months and have a sub-optimal response, meaning the treatment did not work as well as expected.
  • For some study groups, must have been previously treated with ruxolitinib and meet specific criteria related to treatment response or side effects.
  • Must not be a candidate for, or must have refused, allogenic stem cell transplant (SCT), which is a procedure that replaces damaged bone marrow with healthy cells.

Who cannot join the trial?

12 criteria

  • Patients with any other serious medical condition that might affect their ability to participate in the study.
  • Patients who have had another type of cancer within the last 3 years, except for certain skin cancers or cervical cancer that has been treated.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that requires treatment with antibiotics, antivirals, or antifungals.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who have a known allergy to any of the study drugs or their ingredients.
  • Patients who have received another investigational drug within the last 4 weeks.
  • Patients who have a history of certain heart problems, such as a heart attack or heart failure.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have a history of bleeding disorders or are taking blood thinners that cannot be stopped.
  • Patients who have a history of drug or alcohol abuse within the last 2 years.
  • Patients who have a mental health condition that might affect their ability to participate in the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • BMS-986158

    is an experimental medication being tested to see how safe and tolerable it is for people with a condition called myelofibrosis, which affects the bone marrow. This medication is being studied both on its own and in combination with other treatments to find the best dose that can be used safely.

  • Ruxolitinib

    is a medication that is already used to treat myelofibrosis. It works by blocking certain proteins in the body that can cause inflammation and other symptoms of the disease. In this trial, it is being combined with BMS-986158 to see if the combination is more effective for patients who have not been treated before.

  • Fedratinib

    is another medication used to treat myelofibrosis, especially in patients who have already been treated with ruxolitinib. It also works by targeting specific proteins involved in the disease. In this study, it is being tested in combination with BMS-986158 to see if it can help patients who have already tried other treatments.

What is already known about the treatment

BMS-986158 – BMS-986158 is an experimental medication currently being studied for its potential use in treating myelofibrosis, a type of bone marrow cancer. It is administered orally, meaning it is taken by mouth in the form of a pill. The medication is in the early stages of clinical trials, where researchers are assessing its safety and determining the appropriate dosage when used alone or in combination with other drugs like ruxolitinib or fedratinib. BMS-986158 works by targeting specific proteins in cancer cells, which may help to slow down or stop their growth. It is classified as a targeted therapy, focusing on the molecular changes that drive cancer growth.

Investigated diseases

Myelofibrosis – Myelofibrosis is a rare bone marrow disorder characterized by the replacement of bone marrow with fibrous tissue. This process disrupts the body's ability to produce blood cells, leading to anemia, weakness, and fatigue. As the disease progresses, the spleen and liver may enlarge due to the increased workload of producing blood cells. Patients may experience symptoms such as night sweats, fever, and bone pain. Over time, myelofibrosis can lead to severe complications due to the lack of healthy blood cells. The disease can evolve slowly, with symptoms worsening gradually over several years.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509635-89-00Protocol codeCA011-023Estimated enrolment224 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.