Trial comparing treatments for Diffuse Large B-Cell Lymphoma
Official title 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)
ClinicalTrials.gov ID: NCT06717347
What this study is testing
What is Zilovertamab vedotin?
an investigational IV infusion being studied as a potential treatment for diffuse large B‑cell lymphoma is designed to bind to the ROR1 protein on cancer cells and deliver a cell‑killing agent directly to those cells
Also referred to as MK-2140, VLS-101.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if combining a new drug called zilovertamab vedotin with standard treatment helps people live longer without their cancer growing or spreading compared to standard treatment alone.
- Who it's for
- The study is looking for people who have been newly diagnosed with diffuse large B-cell lymphoma (a type of blood cancer) and have not received treatment for it yet.
- What's involved
- Participants will receive either the new drug plus standard chemotherapy or standard chemotherapy alone, along with regular medical visits and tests to monitor their health.
- Time commitment
- The study involves ongoing treatment and regular check-ups for as long as the cancer is controlled or until the study ends.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO...
- Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale
- Has received no prior treatment for their DLBCL
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
- Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)
You likely can't join if
- Has a history of transformation of indolent disease to DLBCL
- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma
- Has Ann Arbor Stage I DLBCL
- Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial...
- Has clinically significant pericardial or pleural effusion
- Has ongoing Grade \>1 peripheral neuropathy
See the full eligibility criteria
- Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues
- Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale
- Has received no prior treatment for their DLBCL
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
- Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)
- Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Has a history of transformation of indolent disease to DLBCL
- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma
- Has Ann Arbor Stage I DLBCL
- Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive...
- Has clinically significant pericardial or pleural effusion
- Has ongoing Grade \>1 peripheral neuropathy
- Has a demyelinating form of Charcot-Marie-Tooth disease
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has ongoing corticosteroid therapy
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
- Known additional malignancy that is progressing or has required active treatment within the past 2 years
- Known active central nervous system (CNS) lymphoma
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has active infection requiring systemic therapy
- Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection
- Has history of allogeneic tissue/solid organ transplant
The study team makes the final eligibility decision.
Where it is enrolling
- Mobile, Alabama, United States
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Fullerton, California, United States
- Long Beach, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Golden, Colorado, United States
- Clermont, Florida, United States
- Hialeah, Florida, United States
- Ocoee, Florida, United States
- Orange City, Florida, United States
- Tampa, Florida, United States
- Athens, Georgia, United States
- Hinsdale, Illinois, United States
- Naperville, Illinois, United States
- O'Fallon, Illinois, United States
- Fort Wayne, Indiana, United States
+ 218 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Mobile, Alabama, United States; Gilbert, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Fullerton, California, United States; Long Beach, California, United States and 232 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.