Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)
This research study is looking at a new medicine called nemtabrutinib (also known as MK-1026) for people with specific types of blood cancers, including different forms of non-Hodgkin's lymphoma (like marginal zone, mantle cell, follicular, and Waldenström's macroglobulinemia), and chronic lymphocytic leukaemia. The main goals are to understand how well the drug works and if it's safe for patients. The study has two main parts: first, finding the best dose, and then giving the drug to larger groups of people with different blood cancers. Scientists want to know if nemtabrutinib could be a helpful new treatment option for these conditions.
At a glance
What is this study about?
This study is about a new medicine called nemtabrutinib, which researchers hope might help people with certain blood cancers. Blood cancers are conditions where the body makes too many abnormal blood cells, which can cause problems. The specific types of blood cancers this study is looking at include various kinds of lymphoma, which is a cancer of the lymphatic system, and chronic lymphocytic leukaemia (CLL), a type of cancer that starts in white blood cells in the bone marrow. The medicine has also been called ARQ 531 in the past.
The main purpose of this study is to carefully check if nemtabrutinib is safe to use and how well it works in treating these conditions. When scientists develop a new medicine, they need to test it thoroughly. This study is in 'Phase 2', which means they've already done some initial safety tests and are now focusing on whether it's effective for a wider group of people and to find the best dose.
The study will happen in two stages. First, a small group of patients will help find the right dose of nemtabrutinib – this is called "Dose Escalation." Once that’s decided, more people will join the study, divided into different groups based on their specific type of blood cancer. This will help researchers see how the medicine works for each condition. By participating, you could help doctors learn more about this potential new treatment.
Key takeaways
- This study is testing a new drug, nemtabrutinib, for certain blood cancers.
- It aims to find out if nemtabrutinib is safe and effective.
- The study includes people with different types of lymphoma and leukaemia.
- It involves taking a pill and having regular check-ups at a clinic.
- You can withdraw from the study at any time if you choose.
- Your participation could help develop future cancer treatments.
Who may be eligible?
To join this study, people generally need to be at least 18 years old. You would need to be able to swallow medicines and be in reasonably good health, as judged by the study doctor, with a life expectancy of at least three months. Your organs, like your liver and kidneys, need to be working well.
There are also specific requirements for people with certain health conditions. For example, if you have Hepatitis B or C, you might still be able to join if your viral levels are very low and you’re receiving treatment for Hepatitis B. Those with HIV might also be eligible if their condition is well-managed and their immune system is stable with treatment.
If you're a woman who could become pregnant, you would need to use effective birth control during the study and for some time after. Men would also need to use contraception or avoid fathering children during the study period. These rules help protect against potential risks to unborn babies.
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 one of the blood cancers mentioned (e.g., specific lymphomas or CLL)?
- Are you generally able to swallow pills?
- Do you believe you would be able to attend regular clinic visits?
- Are your major organs (like liver, kidneys) generally working well?
- If you have Hepatitis B, C, or HIV, is it well-managed and stable?
What does participation involve?
If you decide to take part in this study, the exact details of what you'll need to do can vary depending on which part of the study you join. In general, you would take the study medicine, nemtabrutinib, as directed by the study team. This is an oral medication, meaning you would swallow the pills.
You would have regular visits to the clinic for check-ups. These visits will involve various assessments, such as blood tests, physical examinations, and possibly other tests to see how the medicine is affecting your body and your cancer. These tests help the doctors monitor your health and how the treatment is working. The study team will explain the schedule of these visits and tests before you agree to participate.
After you stop taking the study medicine, there will likely be follow-up appointments to ensure your health is stable and to continue monitoring any effects of the treatment. The total time you would be involved in the study – from starting treatment to the final follow-up – will be clearly explained by the research team. This could last for many months, depending on your individual response and the study's design.
Potential risks and benefits
Locations (121)
- Highlands Oncology Group ( Site 2728)Verified postcodeSpringdale, United States· Recruiting
- University of California San Diego Moores Cancer Center ( Site 2717)Verified postcodeLa Jolla, United States· Recruiting
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site 2724)Verified postcodeTorrance, United States· Completed
- Colorado Blood Cancer Institute ( Site 2726)Verified postcodeDenver, United States· Recruiting
- The University of Louisville, James Graham Brown Cancer Center ( Site 2729)Verified postcodeLouisville, United States· Completed
- Mayo Clinic - Rochester ( Site 2706)Verified postcodeRochester, United States· Active not recruiting
- Astera Cancer Care ( Site 2732)Verified postcodeEast Brunswick, United States· Recruiting
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704)Verified postcodeHackensack, United States· Recruiting
- Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2708)Verified postcodeFargo, United States· Completed
- UT Southwestern-Harold C. Simmons Cancer Center ( Site 2730)Verified postcodeDallas, United States· Recruiting
- Medical Oncology Associates (Summit Cancer Centers) ( Site 2710)Verified postcodeSpokane, United States· Recruiting
- Hospital Aleman ( Site 0102)UnverifiedCiudad Autonoma de Buenos Aires, Argentina· Recruiting
Common questions
What kind of conditions is this study looking at?
This study is for specific blood cancers, including various types of Non-Hodgkin's Lymphoma (like Waldenström's Macroglobulinemia, marginal zone, mantle cell, follicular) and Chronic Lymphocytic Leukaemia.
What is Nemtabrutinib?
Nemtabrutinib is a new experimental medicine being tested in this study. It's also been called ARQ 531 previously.
What does 'Phase 2' mean for this study?
Phase 2 means the drug has already passed initial safety tests, and now researchers are focusing on how well it works and finding the right dose for different types of cancer.
Will I have to stay in hospital?
The study involves taking oral medication and attending regular clinic visits for check-ups and tests; it does not typically require an inpatient hospital stay unless medically necessary.
Can I leave the study if I change my mind?
Yes, you can choose to stop participating in the study at any time, for any reason, without affecting your regular medical care.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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