Compares two treatment combinations for a fast-growing blood cancer called DLBCL
Tests zilovertamab vedotin with standard chemotherapy in adults with newly diagnosed lymphoma.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Aylesbury, Birmingham, Bristol, Exeter, Lincoln, Liverpool, London, Manchester, Middlesbrough, Oxford, and Plymouth, United KingdomSee the 12 sitesAlso in 8 other countries, 142 sites
- Trial code
- NCT06890884
- EU 2024-515526-89-00
- JRCT2021250001
- U1111-1309-2852
- Registry title
- A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 594 people, planned
- Started
- 11 Apr 2025
- Expected to end
- 16 Dec 2032
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Zilovertamab vedotin
- Rituximab
- Cyclophosphamide
- Doxorubicin
- Rituximab Biosimilar
- Prednisone
- Prednisolone
- Polatuzumab vedotin
- Rescue Medication
- Record updated
- 13 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with GCB-type diffuse large B-cell lymphoma who have not had any treatment for it yet.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- GCB subtype of diffuse large B-cell lymphoma (DLBCL), confirmed by a biopsy, with a positive PET scan at screening (4 to 5 on the Lugano 5-point scale).
- Earlier treatment
- No earlier treatment for DLBCL.
- Biomarker or test result
- GCB (germinal center B-cell) subtype on biopsy. People with HIV, hepatitis B or hepatitis C can join only if the infection is controlled or the virus cannot be detected.
Main reasons for not taking part
- Lymphoma that changed from a slow-growing type into DLBCL
- Primary mediastinal B-cell lymphoma or Grey zone lymphoma
- Ann Arbor Stage I DLBCL
- Active lymphoma in the central nervous system
- History of stem cell or solid organ transplant
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- The main inclusion criteria include but are not limited to the following:
- Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (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
- Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants 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
Who cannot take part
- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma
- 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 ongoing corticosteroid therapy
- Has a history of transformation of indolent disease to DLBCL
- 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
- Known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has active infection requiring systemic therapy
- Has active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection
- Has history of stem cell/solid organ transplant
- The main exclusion criteria include but are not limited to the following:
- Has Ann Arbor Stage I DLBCL
- Has clinically significant pericardial or pleural effusion
- Has ongoing Grade >1 peripheral neuropathy
- Known active central nervous system (CNS) lymphoma
Where in United Kingdom
Also in 8 other countries, 142 sites
- Stoke Mandeville Hospital (Site 0917)Aylesbury, United KingdomContact: Study CoordinatorTaking people
- Queen Elizabeth Hospital Birmingham (Site 0912)Birmingham, United KingdomContact: Study CoordinatorTaking people
- Bristol Haematology and Oncology Centre (Site 0908)Bristol, United KingdomContact: Study CoordinatorTaking people
- Royal Devon & Exeter Hospital (Site 0910)Exeter, United KingdomContact: Study CoordinatorTaking people
- Lincoln County Hospital (Site 0906)Lincoln, United KingdomContact: Study CoordinatorTaking people
- Clatterbridge Cancer Centre - Liverpool (Site 0911)Liverpool, United KingdomContact: Study CoordinatorTaking people
- Guy s & St Thomas NHS Foundation Trust (Site 0904)London, United KingdomContact: Study CoordinatorTaking people
- Hammersmith Hospital (Site 0915)London, United KingdomContact: Study CoordinatorTaking people
- Christie Hospital NHS Trust (Site 0901)Manchester, United KingdomContact: Study CoordinatorTaking people
- The James Cook University Hospital (Site 0909)Middlesbrough, United KingdomContact: Study CoordinatorTaking people
- Churchill Hospital (Site 0903)Oxford, United KingdomContact: Study CoordinatorTaking people
- University Hospitals Plymouth NHS Trust (Site 0905)Plymouth, United KingdomContact: Study CoordinatorTaking people
About the trial
What the trial wants to find out
Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing.
Read full original descriptionShow less
The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.
The 2 groups in the trial
- Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)Treatment being tested
Participants will receive a dose of zilovertamab vedotin (1.75 mg/kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 2 additional cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months).
Treatment: Zilovertamab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Rituximab Biosimilar, Prednisone, Prednisolone, and Rescue Medication
- Polatuzumab vedotin + R-CHPExisting treatment, for comparison
Participants will receive a dose of polatuzumab vedotin (1.8 mg/kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar administered by IV infusion on Day 1 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 2 additional cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months).
Treatment: Rituximab, Cyclophosphamide, Doxorubicin, Rituximab Biosimilar, Prednisone, Prednisolone, Polatuzumab vedotin, and Rescue Medication
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)
- Plain-language title
- Compares two treatment combinations for a fast-growing blood cancer called DLBCLGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 13 November 2026