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)
A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-003)
- DLBCL
- Diffuse Large B-Cell Lymphoma
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 290
- Started
- 14 January 2022
- Main results due
- 24 September 2027
- Study sites
- 135
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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 have failed ASCT and have failed at least 2 lines of prior therapy. * Has post-CAR-T therapy failure or is ineligible for CAR-T cell therapy. Exclusion Criteria: * Not applicable with protocol amendment 4: Has history of transformation of indolent disease to DLBCL * Has received solid organ transplant at any time. * Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL). * Has clinically significant (ie, active) cardiovascular disease or serious cardiac arrhythmia requiring medication. * Has ongoing graft-versus-host disease (GVHD) of any grade, or is receiving treatment for their GVHD. * Has clinically significant pericardial or pleural effusion. * Has ongoing Grade \>1 peripheral neuropathy. * Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. * Has a demyelinating form of Charcot-Marie-Tooth disease. * Has contraindication to any of the study intervention components including but not limited to prior anaphylactic reaction. * Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention. * Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. * Has ongoing corticosteroid therapy. * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention. * Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma. Participants with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for cerebrospinal fluid disease), and clinical remission. * Has an active infection requiring systemic therapy. * Has a known history of human immunodeficiency virus (HIV) infection. * Has a known active Hepatitis C virus infection. * Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
What this study is about
In the sponsor’s own words, from the registry.
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. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR.
With protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab \[BR\] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B.
Study sites(135)
Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175)
Glendale, Arizona, United States
Recruiting
Beverly Hills Cancer Center ( Site 0184)
Beverly Hills, California, United States
Active, not recruiting
Bass Medical Group ( Site 0166)
Walnut Creek, California, United States
Recruiting
Innovative Clinical Research Institute ( Site 0122)
Whittier, California, United States
Completed
Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163)
Boca Raton, Florida, United States
Recruiting
Clermont Oncology Center ( Site 0174)
Clermont, Florida, United States
Recruiting
BRP-Hialeah Hospital ( Site 0182)
Hialeah, Florida, United States
Recruiting
Illinois Cancer Specialists ( Site 8000)
Niles, Illinois, United States
Recruiting
Saint Elizabeth Medical Center Edgewood ( Site 0165)
Edgewood, Kentucky, United States
Recruiting
University of Kentucky Chandler Medical Center ( Site 0158)
Lexington, Kentucky, United States
Active, not recruiting
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133)
Louisville, Kentucky, United States
Active, not recruiting
University of Maryland ( Site 0123)
Baltimore, Maryland, United States
Active, not recruiting
Dana-Farber Cancer Institute-Lymphoma ( Site 0111)
Boston, Massachusetts, United States
Active, not recruiting
University of Massachusetts Medical School ( Site 0119)
Worcester, Massachusetts, United States
Active, not recruiting
Corewell Health ( Site 0162)
Grand Rapids, Michigan, United States
Recruiting
St. Vincent Frontier Cancer Center-Research ( Site 0108)
Billings, Montana, United States
Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0188)
Grand Island, Nebraska, United States
Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0177)
Omaha, Nebraska, United States
Recruiting
Comprehensive Cancer Centers of Nevada ( Site 0168)
Las Vegas, Nevada, United States
Recruiting
Atlantic Health System ( Site 0116)
Morristown, New Jersey, United States
Completed
Presbyterian Rust Jorgensen Cancer ( Site 9506)
Rio Rancho, New Mexico, United States
Active, not recruiting
New York Medical College ( Site 0113)
Valhalla, New York, United States
Recruiting
Alliance Cancer Specialists (ACS) ( Site 8001)
Horsham, Pennsylvania, United States
Recruiting
Tennessee Cancer Specialists ( Site 7000)
Knoxville, Tennessee, United States
Recruiting
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0156)
Nashville, Tennessee, United States
Completed
Blue Ridge Cancer Care ( Site 0169)
Roanoke, Virginia, United States
Active, not recruiting
Hospital Italiano de Buenos Aires ( Site 2203)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Active, not recruiting
Instituto de Investigaciones Clínicas Mar del Plata ( Site 2205)
Mar del Plata, Buenos Aires, Argentina
Completed
Hospital Aleman ( Site 2200)
Buenos Aites, Buenos Aires F.D., Argentina
Active, not recruiting
Hospital Privado Universitario de Córdoba ( Site 2202)
Córdoba, Córdoba Province, Argentina
Active, not recruiting
Instituto Alexander Fleming ( Site 2201)
CABA, Argentina
Active, not recruiting
Townsville University Hospital ( Site 1800)
Townsville, Queensland, Australia
Active, not recruiting
Grampians Health ( Site 1802)
Ballarat, Victoria, Australia
Recruiting
Royal Perth Hospital-Haematology ( Site 1801)
Perth, Western Australia, Australia
Recruiting
Hospital Erasto Gaertner ( Site 2302)
Curitiba, Paraná, Brazil
Recruiting
Liga Norte Riograndense Contra o Câncer ( Site 2305)
Natal, Rio Grande do Norte, Brazil
Active, not recruiting
Hospital Paulistano ( Site 2300)
São Paulo, Brazil
Active, not recruiting
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)
Toronto, Ontario, Canada
Completed
Biocenter ( Site 2401)
Concepción, Biobio, Chile
Recruiting
IC La Serena Research ( Site 2405)
La Serena, Coquimbo Region, Chile
Active, not recruiting
Oncocentro Valdivia ( Site 2407)
Valdivia, Los Ríos Region, Chile
Recruiting
FALP-UIDO ( Site 2400)
Santiago, Region M. de Santiago, Chile
Completed
Clínica Inmunocel ( Site 2404)
Santiago, Region M. de Santiago, Chile
Recruiting
Clínica RedSalud Vitacura ( Site 2409)
Santiago, Region M. de Santiago, Chile
Recruiting
Bradfordhill ( Site 2403)
Santiago, Region M. de Santiago, Chile
Recruiting
Beijing Cancer hospital ( Site 3000)
Beijing, Beijing Municipality, China
Active, not recruiting
Chongqing University Cancer Hospital-Medical Oncology ( Site 3025)
Chongqing, Chongqing Municipality, China
Active, not recruiting
Chongqing University Three Gorges Hospital ( Site 3026)
Chongqing, Chongqing Municipality, China
Active, not recruiting
Sun Yat-sen University Cancer Center-Internal Medicine ( Site 3001)
Guangzhou, Guangdong, China
Active, not recruiting
Zhujiang Hospital ( Site 3002)
Guangzhou, Guangdong, China
Active, not recruiting
The First Affiliated Hospital of Henan University of Science &Technology ( Site 3029)
Luoyang, Henan, China
Active, not recruiting
Henan Cancer Hospital-hematology department ( Site 3013)
Zhengzhou, Henan, China
Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 3017)
Wuhan, Hubei, China
Recruiting
The First Affiliated Hospital of Nanchang University ( Site 3004)
Nanchang, Jiangxi, China
Completed
Jiangxi Provincial Cancer Hospital ( Site 3005)
Nanchang, Jiangxi, China
Recruiting
The First Hospital of Jilin University-Hematology ( Site 3012)
Changchun, Jilin, China
Active, not recruiting
Fudan University Shanghai Cancer Center ( Site 3009)
Shanghai, Shanghai Municipality, China
Recruiting
Sichuan Cancer hospital-Oncology ( Site 3021)
Chengdu, Sichuan, China
Active, not recruiting
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 3016)
Chengdu, Sichuan, China
Active, not recruiting
Zhejiang Cancer Hospital ( Site 3014)
Hangzhou, Zhejiang, China
Recruiting
Showing 60 of 135 sites — filter to narrow it down. 50 of the 135 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05139017. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me