All studies
RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)

This study is investigating a new treatment approach for people diagnosed with diffuse large B-cell lymphoma (DLBCL), a type of blood cancer. Researchers are testing a drug called zilovertamab vedotin alongside the usual treatment, which involves a combination of other medicines such as rituximab, cyclophosphamide, doxorubicin, and prednisone. The main goal is to find out if adding zilovertamab vedotin helps patients live longer without their cancer growing or spreading. This is being compared to patients who receive only the standard treatment. By doing this research, doctors hope to improve the outcomes for people with newly diagnosed DLBCL.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
1,046
Start
27 Jan 2025
Estimated completion
29 Mar 2032

What is this study about?

This study is all about trying to find a better way to treat a type of cancer called diffuse large B-cell lymphoma, or DLBCL. This is a cancer that starts in certain white blood cells. If you've recently been diagnosed with DLBCL and haven't started treatment yet, this study might be relevant to you.

Currently, the standard way to treat DLBCL involves a combination of several powerful medicines, often called R-CHOP. This study is testing if adding a new drug, called zilovertamab vedotin, to a slightly different combination of these standard medicines (called R-CHP) can make the treatment even more effective. The researchers want to see if the new combination can help people live longer without their cancer getting worse or coming back, compared to those who just receive the standard R-CHOP treatment.

Taking part in this study means you would be randomly assigned to receive either the new combination treatment or the standard treatment. This is a common way to test new medicines fairly, making sure that any differences seen are truly due to the new drug. The overall aim is to see if this new approach could become a better option for people with DLBCL in the future.

Key takeaways

  • This study is for newly diagnosed diffuse large B-cell lymphoma (DLBCL).
  • It compares a new drug (zilovertamab vedotin) plus standard treatment to standard treatment alone.
  • The main goal is to see if the new combination helps people live longer without their cancer growing.
  • Participation involves regular clinic visits, tests, and active treatment.
  • You would be randomly assigned to one of the two treatment groups.
  • There are potential benefits and risks; you can leave the study at any time.

Who may be eligible?

To join this study, you must have been recently diagnosed with diffuse large B-cell lymphoma (DLBCL) and not yet had any treatment for it. Your diagnosis needs to be confirmed by a specialist. Doctors will also check that your cancer shows up on a special scan called a PET scan.

There are also some general health requirements. For example, your heart should be healthy enough, and if you have conditions like HIV or hepatitis B/C, they need to be well-managed. You should generally be able to manage your daily activities without much difficulty. The study is open to both men and women, aged 18 and over.

However, some things would prevent you from joining. For instance, if your DLBCL started from another, less aggressive type of lymphoma, or if you have a specific type called primary mediastinal B-cell lymphoma. If you have severe heart problems, nerve damage, or certain other serious health issues, you might not be able to participate. Also, you shouldn't have received a live vaccine recently.

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.

  1. Have I been recently diagnosed with diffuse large B-cell lymphoma (DLBCL)?
  2. Have I NOT had any treatment for DLBCL yet?
  3. Am I generally able to carry out my daily activities without too much difficulty?
  4. Do I have any significant heart problems or severe nerve damage?
  5. Am I aged 18 or older?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new treatment combination (zilovertamab vedotin plus R-CHP) or the standard treatment (R-CHOP). The treatments involve a series of cycles, which means you'll have specific medications given over a period, followed by a break, and then another round of treatment. The medicines are given in different ways, some through a drip (intravenous) and some as tablets.

You would have regular visits to the clinic for your treatments, blood tests, physical exams, and scans (like PET scans) to check how you're responding to the treatment and to monitor your general health. There would also be follow-up appointments after your main treatment period ends to keep an eye on your long-term health.

The total duration of the study participation, including treatment and follow-up, can vary for each person but generally involves several months of active treatment and ongoing monitoring for a longer period.

Potential risks and benefits

Potential benefits could include receiving a new treatment that might be more effective than standard care, potentially leading to better outcomes for your cancer. You would also receive very close medical attention and monitoring throughout the study. However, there are potential risks, as with any medical treatment. These medicines can have side effects, which your medical team will explain in detail. These could range from mild to serious, and some side effects might be new or different from those experienced with standard treatment. It's important to remember that there's no guarantee the new treatment will be better for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (262)

  • Banner MD Anderson Cancer Center ( Site 0165)
    Verified postcode
    Gilbert, United States· Recruiting
  • Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0167)
    Verified postcode
    Phoenix, United States· Recruiting
  • The University of Arizona Cancer Center - North Campus ( Site 0124)
    Verified postcode
    Tucson, United States· Recruiting
  • Providence Medical Foundation-Oncology ( Site 0168)
    Verified postcode
    Fullerton, United States· Recruiting
  • MemorialCare Health System - Long Beach Medical Center ( Site 9559)
    Verified postcode
    Long Beach, United States· Recruiting
  • Cancer Blood and Specialty Clinic ( Site 0109)
    Verified postcode
    Los Alamitos, United States· Recruiting
  • Cedars-Sinai Medical Center ( Site 0115)
    Verified postcode
    Los Angeles, United States· Recruiting
  • Pacific Hematology Oncology Associates ( Site 0131)
    Verified postcode
    San Francisco, United States· Recruiting
  • Lutheran Hospital - Cancer Centers of Colorado ( Site 0180)
    Verified postcode
    Golden, United States· Recruiting
  • Clermont Oncology Center ( Site 0182)
    Verified postcode
    Clermont, United States· Recruiting
  • Bioresearch Partner ( Site 0157)
    Verified postcode
    Hialeah, United States· Recruiting
  • Orlando Health Cancer Institute ( Site 0169)
    Verified postcode
    Ocoee, United States· Recruiting

Common questions

What is diffuse large B-cell lymphoma (DLBCL)?

DLBCL is a fast-growing type of blood cancer that affects white blood cells called B-cells. It can appear in lymph nodes or other parts of the body.

What does 'standard treatment' mean in this study?

Standard treatment usually refers to a combination of chemotherapy drugs and other medicines, often called R-CHOP, which is a common and effective treatment for DLBCL.

What is zilovertamab vedotin?

Zilovertamab vedotin is an investigational drug, meaning it's still being studied. It's designed to target cancer cells more specifically.

Will I know if I'm getting the new drug or standard treatment?

No, in this type of study (called a 'randomised' study), you won't know which treatment group you are in. This helps ensure the results are fair and accurate.

Can I stop being part of the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your 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?

Register your interest

Share your details and the research team for "A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combinati…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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