Home › Trials › NCT06717347

Evaluating a new treatment combination for untreated diffuse large B-cell lymphoma

A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06717347

This study is testing a new treatment that combines zilovertamab vedotin with standard chemotherapy to see if it helps people with untreated diffuse large B-cell lymphoma live longer without their cancer getting worse.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1046 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionszilovertamab
Locations253 sites (Gilbert, Arizona and 252 other locations)
Trial IDNCT06717347 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of zilovertamab vedotin combined with standard chemotherapy (R-CHP) compared to the traditional R-CHOP regimen in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Participants will be monitored for progression-free survival, which measures how long they can live without the cancer worsening. The study includes patients with confirmed DLBCL who have not received prior treatment and have specific health criteria. The goal is to determine if the new combination can improve outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are individuals with newly diagnosed diffuse large B-cell lymphoma who have not undergone any prior treatment.

Not a fit: Patients with previously treated diffuse large B-cell lymphoma or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to longer survival rates and better management of diffuse large B-cell lymphoma.

How similar studies have performed: Other studies have shown promising results with similar treatment combinations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion Criteria:

* 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 heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication
* 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

Where this trial is running

Gilbert, Arizona and 252 other locations

+203 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diffuse Large B-Cell LymphomaLymphoma, Large B-Cell, Diffuse
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.