A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)
This research is looking at a new drug, zilovertamab vedotin (ZV), alongside existing treatments for diffuse large B-cell lymphoma (DLBCL). This type of lymphoma is aggressive, and the study focuses on patients whose condition has returned or not improved with past treatments. The main goal is to see if adding ZV helps patients live longer without their cancer getting worse, compared to standard treatments alone. The study is divided into two main parts: first, to establish the best dose of the new drug in combination, and then to properly test how well it works. Participants will be at least 18 years old. We want to find out if these new combinations are better and safer than current options.
At a glance
What is this study about?
This study is investigating a new treatment for an aggressive type of cancer called diffuse large B-cell lymphoma (DLBCL). Specifically, it's for people whose DLBCL has either come back after treatment (relapsed) or hasn't responded to previous treatments (refractory). This is often referred to as 'rrDLBCL'. The new medicine being tested is called zilovertamab vedotin (ZV). Researchers want to see if adding ZV to some of the standard treatments already used for DLBCL can improve how well patients respond and how long they live without their cancer getting worse.
The study is designed in two main stages. The first stage will help determine the safest and most effective dose of ZV when given with standard treatments. Once that's established, the second stage will compare the new combination treatments more widely against the standard treatments alone. The main standard treatment combination being looked at in this study is called R-GemOx (which includes rituximab, gemcitabine, and oxaliplatin). The hope is that adding ZV will significantly improve the outcomes for patients with rrDLBCL. This kind of research is crucial because it helps us find new and better ways to treat serious illnesses like lymphoma.
It's important to know that while the study initially planned to look at another combination called BR (bendamustine and rituximab) with ZV, that part of the study has now stopped enrolling participants. So, the current focus is solely on the ZV plus R-GemOx combination versus R-GemOx alone. This update ensures the trial is focused on the most promising avenues based on the latest information, aiming to bring better options to patients as safely and quickly as possible.
Key takeaways
- Tests a new drug (ZV) for relapsed or refractory DLBCL.
- Compares ZV + standard treatment (R-GemOx) to standard treatment alone.
- Aims to see if ZV improves how long patients live without their cancer getting worse.
- Enrollment focuses on specific patient groups, including those who have tried other therapies.
- Participation involves receiving study treatment, regular check-ups, and scans.
Who may be eligible?
To join this study, you must have an official diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) that can be measured on scans. Your general health and ability to perform daily activities should be reasonable (doctors use a scale for this, and you'd need to be within a certain range).
Specifically for the ZV plus R-GemOx part of the study, your DLBCL must have either come back or not responded to at least one previous treatment. This applies if you haven't had a stem-cell transplant, or if one didn't work. Also, if you've tried or can't have a newer treatment called CAR-T cell therapy, you might be eligible.
There are also some reasons why you might not be able to join. For example, if you've had certain other cancers recently, a solid organ transplant, specific heart problems, ongoing issues like graft-versus-host disease, or significant nerve damage, you likely wouldn't be able to take part. The research team will carefully check all your medical information to see if this study is suitable and safe for you.
- Do you have a confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL)?
- Can your DLBCL be seen and measured on scans?
- Has your DLBCL come back or not responded to at least one previous treatment?
- Are you generally able to manage daily activities without too much difficulty?
- Do you have adequate organ function (kidneys, liver, etc. working well enough)?
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'll receive either the new drug combination (zilovertamab vedotin plus R-GemOx) or the standard R-GemOx treatment, given alongside other routine care like G-CSF (a medicine that helps your body make white blood cells). The specific schedule for your medication and how many hospital visits you'll need will be explained by the study team. You'll have regular appointments for check-ups, blood tests, and scans to monitor your health and how your cancer is responding. These assessments are crucial for the researchers to understand the safety and effectiveness of the treatments. You'll also be asked to provide a recent or stored tissue sample from your lymphoma. The overall duration of your participation, including treatment and follow-up, will be clearly outlined by the study team, but typically clinical trials involve ongoing monitoring for some time.
Potential risks and benefits
Locations (132)
- Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175)Glendale, United States· Recruiting
- Beverly Hills Cancer Center ( Site 0184)Beverly Hills, United States· Recruiting
- Bass Medical Group ( Site 0166)Walnut Creek, United States· Recruiting
- Innovative Clinical Research Institute ( Site 0122)Whittier, United States· Completed
- Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163)Boca Raton, United States· Recruiting
- Clermont Oncology Center ( Site 0174)Clermont, United States· Recruiting
- BRP-Hialeah Hospital ( Site 0182)Hialeah, United States· Recruiting
- Illinois Cancer Specialists ( Site 8000)Niles, United States· Recruiting
- Saint Elizabeth Medical Center Edgewood ( Site 0165)Edgewood, United States· Recruiting
- University of Kentucky Chandler Medical Center ( Site 0158)Lexington, United States· Recruiting
- Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133)Louisville, United States· Recruiting
- University of Maryland ( Site 0123)Baltimore, United States· Recruiting
+120 more sites — see the official record for the full list.
Common questions
What is DLBCL?
DLBCL stands for Diffuse Large B-Cell Lymphoma. It's a fast-growing type of cancer that affects certain white blood cells called B-cells.
What does 'relapsed or refractory' mean?
Relapsed means your cancer came back after treatment, and refractory means it didn't respond to previous treatments.
What is zilovertamab vedotin (ZV)?
Zilovertamab vedotin is an investigational new medicine being tested in this study to see if it can help treat DLBCL.
Will I definitely get the new drug?
This is a randomised study, meaning you will be randomly assigned to receive either the new combination treatment or standard treatment. You won't get to choose.
What is R-GemOx?
R-GemOx is a standard combination of medicines (rituximab, gemcitabine, and oxaliplatin) currently used to treat certain cancers, including lymphoma.
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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