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RecruitingLast updated: 3 July 2025

waveLINE-010: A study recruiting people with previously untreated diffuse large B-cell lymphoma to evaluate whether a targeted drug when given with standard chemotherapy treatment can help people live longer without the cancer growing or spreadingA 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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

waveLINE-010

Clinical summary

Summary

Eligible participants will be assigned to one of two treatment groups.

In the Experimental Group, participants will receive zilovertamab vedotin, which is a type of targeted drug called an antibody-drug conjugate, plus R-CHP chemotherapy regimen. Treatment will be given by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) for up to 6 cycles (approximately 4 months), plus 2 cycles of rituximab for people with high risk DLBCL. 

In the Active Comparator Group, participants will receive R-CHOP chemotherapy regimen. Treatment will be given by IV infusion on Day 1 of each 21-day cycle for up to 6 cycles, plus 2 cycles of rituximab for people with high risk DLBCL.

In both groups, participants also receive prednisone or prednisolone as an oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles.

Conditions

This trial is treating people with previously untreated diffuse large B-cell lymphoma (DLBCL)

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

  • NCT06717347 *
  • 2140-010; MK-2140-010; 2024-515566-13-00; U1111-1309-3971; JRCT2061240099

Trial sponsor

Merck Sharp & Dohme LLC

Scientific Title

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)

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