A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma(waveLINE-004)
This research study, called waveLINE-004, is looking into a new treatment called Zilovertamab vedotin for adults with a specific type of blood cancer: Diffuse Large B-Cell Lymphoma. This is a type of non-Hodgkin's lymphoma. It's particularly for individuals whose cancer has either returned after initial treatment or hasn't improved with previous therapies. This trial is in its second phase, meaning it's still being carefully evaluated. Researchers want to find out how effective and safe this new medicine is. The main thing they're measuring is how many people see their cancer shrink or disappear. They will also look at how long any positive effects last and track any side effects people might experience.
At a glance
What is this study about?
Imagine you have a type of blood cancer called Diffuse Large B-Cell Lymphoma (DLBCL). Sometimes, even after treatments, the cancer can come back (this is called 'relapsed') or it might not respond to treatments at all (called 'refractory'). When this happens, doctors are always looking for new options to help patients.
This study is testing a new experimental medicine called Zilovertamab vedotin. It's like a special key designed to target and potentially stop the cancer cells. The 'Phase 2' in the study title means that researchers have already done some early safety tests and now they want to see how well it works and continue to monitor for side effects in a larger group of people. It's a stepping stone before a much larger study.
The main goal of this particular study is to see how many participants respond to the treatment. This 'response' means whether their cancer shrinks or even disappears completely according to specific medical guidelines. They will also carefully watch for any side effects and how long the treatment's positive effects last. This information is crucial to understand if Zilovertamab vedotin could be a helpful new treatment option for people with relapsed or refractory DLBCL.
Key takeaways
- This study is for adults with a specific type of blood cancer (DLBCL) that has returned or not responded to previous treatments.
- It's testing a new medicine called Zilovertamab vedotin to see how well it works and if it's safe.
- The main goal is to measure how many patients see their cancer shrink or disappear.
- Participation involves regular clinic visits, blood tests, and scans.
- You can stop participating in the study at any time.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. Both men and women are welcome to take part. The most important health requirement is that you must have Diffuse Large B-Cell Lymphoma that has either returned after you've had previous treatments, or it hasn't improved with those treatments. This means your cancer is considered 'relapsed or refractory'.
There will be other specific health requirements that your study doctor will discuss with you. These are to make sure the study is safe for you and that the results of the study are clear. For example, they will check your overall health, other medical conditions you might have, and if you're taking any other medicines.
It's important to remember that joining a clinical study is a big decision. Your doctor and the study team will go through all the details with you, including what tests you'll need, to see if this study is the right fit for your situation. They will also explain criteria that might prevent you from joining, such as certain past medical conditions or recent treatments.
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?
- Have you been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL)?
- Has your DLBCL either relapsed (come back) or been refractory (not responded to previous treatments)?
- Are you able to attend regular clinic visits and tests?
What does participation involve?
If you decide to join this study, you would receive the investigational medicine, Zilovertamab vedotin, as part of your treatment. The study team would closely monitor your health throughout the trial. This would involve regular visits to the clinic for check-ups, blood tests, and scans to see how your body is responding to the treatment and to keep an eye on your cancer. These tests are important for both your safety and to understand how well the medicine is working.
The study would involve a specific schedule of treatments, which your doctor would explain to you clearly. You would also need to report any new symptoms or side effects you experience to the study team. After the treatment phase, there would be follow-up appointments to continue monitoring your health and the long-term effects of the medicine. The total duration of your participation would depend on how you respond to the treatment and the study's design, but the study team will provide you with a detailed timeline.
Potential risks and benefits
Locations (9)
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Common questions
What is Diffuse Large B-Cell Lymphoma?
It's a fast-growing type of blood cancer that affects certain white blood cells called B-cells. It's the most common type of non-Hodgkin's lymphoma.
What does 'relapsed or refractory' mean?
'Relapsed' means your cancer has come back after treatment. 'Refractory' means your cancer didn't respond to previous treatments.
What is a 'Phase 2' study?
A Phase 2 study is a stage in testing a new medicine where researchers are mainly looking at how well it works against the disease and continuing to check for side effects in a larger group of people.
What is Zilovertamab vedotin?
It's the name of the new experimental medicine being tested in this study for treating Diffuse Large B-Cell Lymphoma.
Will I get this new medicine for sure if I join?
Yes, in this specific type of study (open-label), all participants who meet the criteria would receive the Zilovertamab vedotin treatment.
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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