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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)

NCT ID: NCT06890884

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

594 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-11

Study Completion Date

2032-12-16

Brief Summary

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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.

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.

Detailed Description

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Conditions

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Lymphoma, Large B-Cell, Diffuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)

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).

Group Type EXPERIMENTAL

Zilovertamab vedotin

Intervention Type BIOLOGICAL

IV infusion

Rituximab

Intervention Type BIOLOGICAL

IV infusion

Cyclophosphamide

Intervention Type DRUG

IV infusion

Doxorubicin

Intervention Type DRUG

IV infusion

Rituximab Biosimilar

Intervention Type BIOLOGICAL

IV infusion

Prednisone

Intervention Type DRUG

Oral administration or IV infusion

Prednisolone

Intervention Type DRUG

Oral administration or IV infusion

Rescue Medication

Intervention Type DRUG

Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Polatuzumab vedotin + R-CHP

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).

Group Type ACTIVE_COMPARATOR

Rituximab

Intervention Type BIOLOGICAL

IV infusion

Cyclophosphamide

Intervention Type DRUG

IV infusion

Doxorubicin

Intervention Type DRUG

IV infusion

Rituximab Biosimilar

Intervention Type BIOLOGICAL

IV infusion

Prednisone

Intervention Type DRUG

Oral administration or IV infusion

Prednisolone

Intervention Type DRUG

Oral administration or IV infusion

Polatuzumab vedotin

Intervention Type BIOLOGICAL

IV infusion

Rescue Medication

Intervention Type DRUG

Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Interventions

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Zilovertamab vedotin

IV infusion

Intervention Type BIOLOGICAL

Rituximab

IV infusion

Intervention Type BIOLOGICAL

Cyclophosphamide

IV infusion

Intervention Type DRUG

Doxorubicin

IV infusion

Intervention Type DRUG

Rituximab Biosimilar

IV infusion

Intervention Type BIOLOGICAL

Prednisone

Oral administration or IV infusion

Intervention Type DRUG

Prednisolone

Oral administration or IV infusion

Intervention Type DRUG

Polatuzumab vedotin

IV infusion

Intervention Type BIOLOGICAL

Rescue Medication

Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Intervention Type DRUG

Other Intervention Names

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MK-2140 VLS-101 RITUXAN® CYTOXAN® NEOSAR® ADRIAMYCIN® TRUXIMA® RUXIENCE® RIABNI®

Eligibility Criteria

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Inclusion Criteria

* 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.

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.
* 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 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Infirmary Cancer Care ( Site 0157)

Mobile, Alabama, United States

Site Status RECRUITING

Palo Verde Cancer Specialists ( Site 0105)

Glendale, Arizona, United States

Site Status RECRUITING

Genesis Cancer and Blood Institute ( Site 0193)

Hot Springs, Arkansas, United States

Site Status RECRUITING

Mount Sinai Cancer Center ( Site 0140)

Miami Beach, Florida, United States

Site Status RECRUITING

Mid Florida Hematology and Oncology Center ( Site 0152)

Orange City, Florida, United States

Site Status RECRUITING

University of Chicago Medical Center ( Site 0126)

Chicago, Illinois, United States

Site Status RECRUITING

University of Iowa-Holden Comprehensive Cancer Center ( Site 0139)

Iowa City, Iowa, United States

Site Status RECRUITING

Mission Blood & Cancer Care ( Site 0114)

Waukee, Iowa, United States

Site Status RECRUITING

Saint Elizabeth Medical Center Edgewood ( Site 0141)

Edgewood, Kentucky, United States

Site Status RECRUITING

Baptist Health Hardin ( Site 0154)

Elizabethtown, Kentucky, United States

Site Status RECRUITING

Baptist Health Lexington ( Site 0127)

Lexington, Kentucky, United States

Site Status RECRUITING

Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185)

Louisville, Kentucky, United States

Site Status RECRUITING

Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180)

Baton Rouge, Louisiana, United States

Site Status RECRUITING

NHO Revive Research Institute, LLC ( Site 0121)

Lincoln, Nebraska, United States

Site Status RECRUITING

University Of Nebraska Medical Center ( Site 0110)

Omaha, Nebraska, United States

Site Status RECRUITING

Atlantic Health Morristown Medical Center ( Site 0163)

Morristown, New Jersey, United States

Site Status RECRUITING

Erie County Medical Center ( Site 0175)

Buffalo, New York, United States

Site Status RECRUITING

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208)

Mineola, New York, United States

Site Status RECRUITING

Clinical Research Alliance ( Site 0122)

Westbury, New York, United States

Site Status RECRUITING

University of North Carolina Medical Center ( Site 0136)

Chapel Hill, North Carolina, United States

Site Status RECRUITING

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0145)

Tyler, Texas, United States

Site Status RECRUITING

SSM Health Dean Medical Group ( Site 0106)

Madison, Wisconsin, United States

Site Status RECRUITING

AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0306)

Mechelen, Antwerpen, Belgium

Site Status RECRUITING

Cliniques Universitaires Saint-Luc ( Site 0302)

Brussels, Bruxelles-Capitale, Region de, Belgium

Site Status RECRUITING

Hopital de Jolimont ( Site 0304)

Haine-Saint-Paul, Hainaut, Belgium

Site Status RECRUITING

UZ Leuven ( Site 0301)

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

AZ Delta ( Site 0303)

Roeselare, West-Vlaanderen, Belgium

Site Status RECRUITING

Universitaetsklinikum Wuerzburg ( Site 0401)

Würzburg, Bavaria, Germany

Site Status RECRUITING

Mater Misercordiae University Hospital ( Site 0501)

Dublin, , Ireland

Site Status RECRUITING

University Hospital Limerick ( Site 0503)

Limerick, , Ireland

Site Status RECRUITING

Rambam Health Care Campus ( Site 0604)

Haifa, , Israel

Site Status RECRUITING

Edith Wolfson Medical Center ( Site 0602)

Holon, , Israel

Site Status RECRUITING

Haddasah Medical Center ( Site 0601)

Jerusalem, , Israel

Site Status RECRUITING

Rabin Medical Center ( Site 0607)

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center ( Site 0603)

Ramat Gan, , Israel

Site Status RECRUITING

ZIV Medical Center ( Site 0605)

Safed, , Israel

Site Status RECRUITING

Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0703)

Alessandria, Ancona, Italy

Site Status RECRUITING

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0707)

Meldola, Forli-Cesena, Italy

Site Status RECRUITING

Istituto Clinico Humanitas ( Site 0704)

Rozzano, Milano, Italy

Site Status RECRUITING

Istituto Europeo di Oncologia ( Site 0701)

Milan, , Italy

Site Status RECRUITING

Universita degli Studi di Napoli Federico II ( Site 0705)

Napoli, , Italy

Site Status RECRUITING

Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 0702)

Palermo, , Italy

Site Status RECRUITING

Arcispedale Santa Maria Nuova ( Site 0706)

Reggio Emilia, , Italy

Site Status RECRUITING

Aichi Cancer Center ( Site 1007)

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Fujita Health University Hospital ( Site 1003)

Toyoake, Aichi-ken, Japan

Site Status RECRUITING

Hokkaido University Hospital ( Site 1004)

Sapporo, Hokkaido, Japan

Site Status RECRUITING

National Hospital Organization Sendai Medical Center ( Site 1005)

Sendai, Miyagi, Japan

Site Status RECRUITING

Kansai Medical University Hospital ( Site 1006)

Hirakata, Osaka, Japan

Site Status RECRUITING

Shimane University Hospital ( Site 1002)

Izumo, Shimane, Japan

Site Status RECRUITING

Nippon Medical School Hospital ( Site 1001)

Bunkyo, Tokyo, Japan

Site Status RECRUITING

National Cancer Center Hospital ( Site 1009)

Chūō, Tokyo, Japan

Site Status RECRUITING

Nagasaki University Hospital ( Site 1008)

Nagasaki, , Japan

Site Status RECRUITING

Pratia MCM Krakow ( Site 0804)

Karkow, Lesser Poland Voivodeship, Poland

Site Status RECRUITING

Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu ( Site 0806)

Nowy Sącz, Lesser Poland Voivodeship, Poland

Site Status RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0803)

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Uniwersyteckie Centrum Kliniczne ( Site 0802)

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Pratia Onkologia Katowice ( Site 0801)

Katowice, Silesian Voivodeship, Poland

Site Status RECRUITING

Bristol Haematology and Oncology Centre ( Site 0908)

Bristol, Bristol, City of, United Kingdom

Site Status RECRUITING

Stoke Mandeville Hospital ( Site 0917)

Aylesbury, Buckinghamshire, United Kingdom

Site Status RECRUITING

University Hospitals Plymouth NHS Trust ( Site 0905)

Plymouth, Devon, United Kingdom

Site Status RECRUITING

Clatterbridge Cancer Centre - Liverpool ( Site 0911)

Liverpool, , United Kingdom

Site Status RECRUITING

Christie Hospital NHS Trust ( Site 0901)

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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United States Belgium Germany Ireland Israel Italy Japan Poland United Kingdom

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Study Coordinator

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Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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2024-515526-89-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1309-2852

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-2140-011

Identifier Type: OTHER

Identifier Source: secondary_id

waveLINE-011

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2021250001

Identifier Type: REGISTRY

Identifier Source: secondary_id

2140-011

Identifier Type: -

Identifier Source: org_study_id