NCT06717347 · Merck Sharp & Dohme LLC
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)
What this study is about
The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.
View original scientific description
The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.
Interventions
BIOLOGICAL
Zilovertamab vedotin
IV infusion
BIOLOGICAL
Rituximab
IV infusion
DRUG
Cyclophosphamide
IV infusion
DRUG
Doxorubicin
IV infusion
BIOLOGICAL
Rituximab Biosimilar
IV infusion
DRUG
Prednisone
Per Approved Product Label
DRUG
Prednisolone
Oral administration
DRUG
Vincristine
IV infusion
DRUG
Rescue medication
Participants receive rescue medication per approved product label. The rescue medication is granulocyte colony-stimulating factor (G-CSF).
DRUG
Methylprednisolone
Per Approved Product Label
Primary outcome measures
Progression-free survival (PFS)
Time frame: Up to ~ 50 months
PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by blinded independent central review (BICR) or death due to any cause, whichever occurs first.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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
Where
- Mobile, Alabama
- Gilbert, Arizona
- Phoenix, Arizona
- Tucson, Arizona
- Fullerton, California
- Long Beach, California
- Los Alamitos, California
- Los Angeles, California
- San Francisco, California
- Golden, Colorado
- Clermont, Florida
- Hialeah, Florida
And 32 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations