NCT05139017 · Merck Sharp & Dohme LLC
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)
What this study is about
The purpose of this Phase 2/3, randomly assigned, multisite, where both patients and doctors know the treatment given, dose confirmation, and expansion study is to evaluate the safety, and effectiveness of zilovertamab vedotin (ZV) in combination with the usual treatment options for the treatment of rrDLBCL.
View original scientific description
The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL.
Interventions
BIOLOGICAL
Zilovertamab vedotin
Intravenous (IV) Infusion 1.5 mg/kg, 1.75 mg/kg, 2.0 mg/kg, 2.25 mg/kg, 2.5 mg/kg
BIOLOGICAL
Rituximab
IV Infusion 375 mg/m\^2
DRUG
Gemcitabine
IV Infusion 1000 mg/m\^2
DRUG
Oxaliplatin
IV Infusion 100 mg/m\^2
DRUG
Bendamustine
IV Infusion 90 mg/m\^2
DRUG
Granulocyte Colony-Stimulating Factor (G-CSF)
Prophylactic G-CSF will be administered at each cycle of zilovertamab vedotin as per the institutional guidelines.
Primary outcome measures
Number of participants who experienced dose-limiting toxicities (DLTs) in Part 1
Time frame: Up to ~6 weeks
The CTCAE, Version 5.0 will be used to grade the severity of AEs in this study. DLTs will be reported for Part 1 of this study.
Number of participants who experienced an adverse event (AE)
Time frame: Up to ~68 months
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experienced an AE will be reported.
Number of participants who discontinued study treatment due to an AE
Time frame: Up to ~68 months
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinued study treatment due to an AE will be reported.
Overall survival (OS)
Time frame: Up to ~35 months
OS, defined as the time from randomization to death due to any cause will be reported.
Progression-free survival (PFS)
Time frame: Up to ~35 months
PFS, defined as the time from randomization to the first documented disease progression per Lugano response criteria as assessed by BICR or death due to any cause, whichever occurs first will be presented.
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 a histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).
- Has radiographically measurable DLBCL per the Lugano Response Criteria, as assessed locally by the investigator.
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 within 7 days prior to study treatment initiation.
- Has adequate organ function.
- Is able to provide new or archival tumor tissue sample not previously irradiated. Zilovertamab vedotin plus R-GemOx, or R-GemOx study arms:
- Has relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least 1 line of prior therapy.
- Has post-chimeric antigen receptor T (post-CAR-T) cell therapy failure or is ineligible for CAR-T cell therapy. Not applicable with protocol amendment 4: Zilovertamab vedotin plus Bendamustine Rituximab (BR), and Bendamustine Rituximab study arms:
- Has relapsed or refractory DLBCL and is ineligible for or
Where
- Glendale, Arizona
- Beverly Hills, California
- Walnut Creek, California
- Whittier, California
- Boca Raton, Florida
- Clermont, Florida
- Hialeah, Florida
- Niles, Illinois
- Edgewood, Kentucky
- Lexington, Kentucky
- Louisville, Kentucky
- Baltimore, Maryland
And 14 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 6, 2026 · Source of record for eligibility and locations