A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)
This study is investigating new medications, zilovertamab vedotin (also known as MK-2140) by itself or combined with nemtabrutinib, to treat specific types of blood cancers called B-cell lymphomas. These include Mantle Cell Lymphoma, Follicular Lymphoma, Richter Transformation Lymphoma, and Chronic Lymphocytic Leukemia. The main goal is to understand how safe these treatments are and how well they work in people whose cancer has either come back after previous treatments (relapsed) or hasn't responded to earlier therapies (refractory). Researchers are especially interested in whether these new drugs can shrink the cancer. This study is for people who have already tried other treatments for their cancer, including those who have had CAR-T cell therapy or are unable to have it. Some parts of the study are now closed for new participants, but those already involved will continue.
At a glance
What is this study about?
This study is about finding new ways to treat several types of B-cell lymphomas, which are cancers affecting certain white blood cells. These include Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), Chronic Lymphocytic Leukemia (CLL), and Richter Transformation Lymphoma (RTL). Currently, these conditions can be challenging to treat, especially when they come back after initial treatments or don't respond well to standard therapies.
The study focuses on a new drug called zilovertamab vedotin, which will be tested on its own and in combination with another drug, nemtabrutinib. The researchers want to see if these treatments are safe for patients and if they can help shrink or control the cancer. This is particularly important for patients whose cancer has not responded to previous treatments, including newer advanced therapies like CAR-T cell therapy, or for those who can't receive such treatments.
By carefully studying how patients react to these new medications, doctors hope to gather important information that could lead to better treatment options in the future. This kind of research is vital for advancing medical care and offering new hope to those living with these conditions. It's a 'Phase 2' study, meaning it's still relatively early-stage, focusing on safety and whether the drugs show promise.
Key takeaways
- Tests new drugs (zilovertamab vedotin, nemtabrutinib) for B-cell lymphomas.
- Aims to find safer and more effective treatments for relapsed/refractory cancers.
- For adults with Mantle Cell Lymphoma, Follicular Lymphoma, or Chronic Lymphocytic Leukemia.
- Participation involves regular clinic visits for treatment and monitoring.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
This study is looking for adults aged 18 and older, both men and women, who have been diagnosed with certain types of B-cell lymphoma or chronic lymphocytic leukemia (CLL). To be considered, your cancer must have either returned after previous treatments or not responded to them (this is called 'relapsed or refractory' disease).
Specifically, if you have Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), or CLL, you generally need to have tried at least two previous treatments. For some types of MCL, this includes trying a specific kind of drug called a Bruton's tyrosine kinase inhibitor (BTKi) or having had (or being unable to have) CAR-T cell therapy. If you have Richter Transformation Lymphoma (RTL), you'll need to have had at least one prior treatment.
There are also some health requirements, such as your general physical well-being being assessed as good enough to take part. Some conditions might prevent you from joining, such as having had an organ transplant in the past or having certain serious heart conditions. If you have hepatitis B, you might still be able to join if your viral levels are very low and controlled by medication.
- Are you 18 years old or older?
- Do you have Mantle Cell Lymphoma, Follicular Lymphoma, Chronic Lymphocytic Leukemia, or Richter Transformation Lymphoma?
- Has your cancer come back or not responded to previous treatments?
- Have you had at least 1-2 (depending on your diagnosis) prior treatments for your cancer?
- Are you able to travel to a study site for regular appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive the study medication, zilovertamab vedotin (and possibly nemtabrutinib), according to a set schedule. This will likely involve regular visits to the clinic for treatments and check-ups. During these visits, the study team will monitor your health closely, take blood samples, and perform scans to see how the treatment is affecting your cancer. They will check for any side effects and adjust your care as needed.
The frequency of visits and tests will vary throughout the study but will be clearly explained to you. You'll have regular contact with the study team, who will be there to answer your questions and support you. The study aims to follow participants for a certain period to gather enough information on the treatment's safety and effectiveness. Importantly, you can choose to leave the study at any time.
Potential risks and benefits
Locations (109)
- Alaska Oncology and Hematology ( Site 0037)Anchorage, United States
- Banner MD Anderson Cancer Center ( Site 0040)Gilbert, United States
- Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036)Phoenix, United States
- University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008)Aurora, United States
- Cancer Care Specialists of Illinois ( Site 0031)Decatur, United States
- University of Kansas Medical Center-Division of Hematologic Malignancies and Cellular Therapeutics ( Site 0038)Fairway, United States
- Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007)Saint Matthews, United States
- Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010)Baltimore, United States
- Tufts Medical Center ( Site 0024)Boston, United States
- Massachusetts General Hospital ( Site 0018)Boston, United States
- Dana-Farber Cancer Institute-Lymphoma ( Site 0026)Boston, United States
- University of Michigan ( Site 0009)Ann Arbor, United States
+97 more sites — see the official record for the full list.
Common questions
What kind of cancers is this study for?
This study is for specific types of B-cell lymphomas, including Mantle Cell Lymphoma, Follicular Lymphoma, and Chronic Lymphocytic Leukemia, especially when they've returned or haven't responded to previous treatments.
What are 'relapsed' or 'refractory' cancers?
Relapsed means your cancer came back after treatment, and refractory means it didn't respond well to previous treatments.
What are the new treatments being tested?
The study is testing new drugs called zilovertamab vedotin, either by itself or combined with nemtabrutinib.
Can I join if I've already had a lot of treatments?
Yes, this study is often for people who have tried several other treatments for their cancer already, including advanced therapies like CAR-T cells.
Do I have to live in a specific area to join?
The study is being conducted at specific hospitals and clinics. You would need to be able to travel to one of these locations for your appointments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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