Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase II Study of Fedratinib and Nivolumab Combination in Patients with Myelofibrosis and Resistance or Suboptimal Response to JAK-inhibitor Treatment - The FRACTION Trial

This study, called FRACTION, is testing a new way to treat myelofibrosis, a rare blood cancer. We're looking at a combination of two drugs, fedratinib (marketed as Inrebic) and nivolumab (marketed as OPDIVO). This trial is for people with myelofibrosis who are already taking a different type of medicine, called a JAK-inhibitor, but it's not working as well as hoped, or they've become resistant to it. The main goal is to find out how effective this new combination is at improving symptoms and reducing the need for blood transfusions over 12 treatment cycles. We'll also be carefully checking for any side effects and looking at other important aspects like quality of life.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Enrolment target

Start

24 Oct 2024

Primary and secondary Myelofibrosis

What is this study about?

This study is a Phase II clinical trial, which means it's one of the earlier steps in testing new treatments. The goal is to see if combining two specific medicines, fedratinib (also known as Inrebic) and nivolumab (also known as OPDIVO), could be a better treatment option for people with myelofibrosis.

Myelofibrosis is a condition where the bone marrow, which usually makes healthy blood cells, becomes scarred. This can lead to serious problems like anaemia (not enough red blood cells), a swollen spleen, and feeling very tired. Many people with myelofibrosis take drugs called JAK-inhibitors, but sometimes these stop working as well, or the person becomes resistant to them. This study is specifically for those individuals.

The main things we want to find out are how well this new drug combination helps to improve the symptoms of myelofibrosis and whether it can reduce how often people need blood transfusions. We'll also be closely monitoring any side effects to make sure the combination is safe, and we'll be looking at how it affects people's overall well-being and quality of life. Understanding these things will help doctors know if this treatment could be a good choice for future patients.

Key takeaways

This study is for adults with myelofibrosis whose current medicine isn't working well.
It tests a new combination of two drugs: fedratinib and nivolumab.
The main goals are to improve symptoms and reduce blood transfusion needs.
Your health will be closely monitored for side effects and how the treatment is working.
It's a Phase II trial, so it's an earlier stage of testing new treatments.
You can stop participating at any time.

Who may be eligible?

This study is open to adults aged 18 and over, no matter their gender. It's specifically for people who have been diagnosed with either primary myelofibrosis (meaning it developed on its own) or secondary myelofibrosis (meaning it developed after another similar blood condition).

A key requirement is that you must have been taking a JAK-inhibitor medicine for your myelofibrosis, but it's either not working as well as it once did, or your condition has progressed despite the treatment. The research team will carefully check your medical history to make sure you fit all the specific criteria for this study.

There will be other detailed medical checks to ensure the treatment is safe for you to take. It's important to discuss your full medical history with the study team to see if this trial is a suitable option.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have primary or secondary myelofibrosis?
Are you currently on a JAK-inhibitor treatment for myelofibrosis?
Is your current JAK-inhibitor treatment not working as well as it used to, or has your condition progressed?
Are you able to attend regular clinic appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive two medicines: OPDIVO (nivolumab) as a liquid given through a drip, and Inrebic (fedratinib) as hard capsules you swallow. The study will involve regular visits to the clinic for treatments, blood tests, and check-ups. The main focus will be over 12 treatment cycles to see how well the treatment works. Beyond that, there will be ongoing safety monitoring. You'll answer questionnaires about your symptoms and quality of life, and the doctors will perform physical examinations. They will also take samples to look at your bone marrow and how your immune system is responding. The total duration of your participation will vary, but regular follow-ups will be needed during and after the treatment period.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment combination that might help your myelofibrosis symptoms and reduce your need for blood transfusions, especially if your current treatment isn't working as well. However, all medicines carry potential risks, and this specific combination could have side effects, which the study doctors will explain in detail. You will be closely monitored for any adverse reactions. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is myelofibrosis?

Myelofibrosis is a rare blood condition where scar tissue forms in the bone marrow, affecting its ability to produce healthy blood cells.

Why is this study being done?

This study aims to find out if combining two medicines, fedratinib and nivolumab, works better for people with myelofibrosis whose current treatment isn't as effective as it should be.

What are the medicines involved?

The study uses two drugs: OPDIVO (nivolumab), which is given as an infusion, and Inrebic (fedratinib), which is taken as capsules.

How long will the treatment part of the study last?

The main part of the study assessing how well the treatment works is over 12 treatment cycles, but overall participation might be longer due to follow-up.

Are there any costs for me to participate?

Generally, medicines and study-related tests in clinical trials are provided at no cost, but you should discuss any potential expenses with the study team.