NCT05144841CompletedPhase 2
A Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004)
A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-004)
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate zilovertamab vedotin with respect to objective response rate and duration of response per Lugano Response Criteria as assessed by blinded independent central review (BICR). Safety and tolerability will also be evaluated in this Phase 2, single arm, interventional study.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 22 Nov 2021
- Start date
- 8 Jan 2022
- Primary completion date
- 21 Apr 2026
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT05144841
- EU CT number
- 2022-501243-33-00
- EudraCT number
- 2021-003397-32
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 140
- From 8 Jan 2022 to the primary completion date, 21 Apr 2026
- 71 sites in 17 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received a diagnosis of Primary mediastinal B-cell lymphoma (PMBCL).
- Has undergone solid organ transplant at any time.
- In participants with prior allo-SCT, acute graft versus host disease (GVHD) or ongoing evidence of chronic GVHD.
- 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 28 days of start of study intervention. Participants.
- must have recovered from all radiation-related toxicities.
- Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent).
- 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.
Other illness
- Has a history of any clinically significant cardiovascular conditions within 6 months of screening or serious cardiac arrhythmia requiring medication.
- Has known history of liver cirrhosis.
- Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- Has an active infection requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a known history of hepatitis B or known active hepatitis C virus (HCV).
Other
- Has pericardial effusion or clinically significant pleural effusion.
- Has ongoing Grade \>1 peripheral neuropathy.
- Transformed DLBCL from indolent lymphoma.
- Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma.
Who the study is looking for
- Has relapsed or refractory (rr) DLBCL; has progressed after at least 2 lines of prior therapy; and has progressed after auto- stem cell transplant (SCT) or are auto-SCT ineligible. Must have received prior multiagent regimen that includes an alkylating agent. anthracycline, and anti-CD20 (cluster of differentiation 20) monoclonal antibody.
- Has histologically confirmed diagnosis of DLBCL.
- Has radiographically measurable DLBCL per the Lugano Response Criteria.
- Should either be post- chimeric antigen receptor T cell therapy (CAR-T) failure or ineligible for CAR-T (for any reason).
- Life expectancy of at least 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before time of enrollment.
- Has adequate organ function.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (71)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0100) Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Clínica Alemana de Santiago ( Site 2704) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| James Lind Centro de Investigación del Cáncer ( Site 2705) Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| Beijing Cancer hospital ( Site 2900) Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University-Hematology ( Site 2910) Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Hunan Cancer Hospital ( Site 2905) Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital of Sichuan University-Head and Neck Oncology ( Site 2911) Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal Medicine ( Site 2907) Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital, Zhejiang University-Bone marrow transplant centre ( Site 2912) Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Fudan University Shanghai Cancer Center ( Site 2908) Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai East Hospital ( Site 2902) Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital-lymphoma ( Site 2901) Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Wuhan Union Hospital ( Site 2906) Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Henan Cancer Hospital-hematology department ( Site 2903) Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Completed |
| Vseobecna Fakultni Nemocnice V Praze Coordinator of this site? Confirm its status | Prague 2 | Czechia | Completed |
| North Estonia Medical Centre Foundation Coordinator of this site? Confirm its status | Tallinn | Estonia | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Catalan Institute of Oncology Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Completed |
| Centre Hospitalier de la Cote Basque Coordinator of this site? Confirm its status | Bayonne | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Completed |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Evangelismos S A Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Soroka Medical Center-Hematology Department ( Site 1403) Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Hadassah Medical Center ( Site 1402) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Shaare Zedek Medical Center ( Site 1404) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sourasky Medical Center ( Site 1400) Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Completed |
| Severance Hospital, Yonsei University Health System-Medical oncology ( Site 0601) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center ( Site 0600) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Helse Bergen HF Coordinator of this site? Confirm its status | Bergen | Norway | Completed |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Completed |
| Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Szpitale Pomorskie Sp z o o Coordinator of this site? Confirm its status | Gdynia | Poland | Completed |
| Pratia Hematologia Sp. Z o. o Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Completed |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Completed |
| Faculty of Medicine Siriraj Hospital ( Site 0701) Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Maharaj Nakorn Chiang Mai Hospital ( Site 0702) Coordinator of this site? Confirm its status | Muang | Thailand | Unknown status |
| University of Michigan ( Site 0200) Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Northside Hospital ( Site 0206) Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0211) Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Massachusetts General Hospital-Cancer Center Protocol Office ( Site 0203) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Chicago Medical Center ( Site 0207) Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0217) Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| University Hospitals Cleveland Medical Center ( Site 0222) Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Karmanos Cancer Institute ( Site 0216) Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Franciscan St. Francis Health ( Site 0225) Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| MEDICAL COLLEGE OF WISCONSIN ( Site 0234) Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Atlantic Health System Morristown Medical Center ( Site 0213) Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0229) Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| AHN West Penn Hospital ( Site 0212) Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Avera Cancer Institute- Research ( Site 0233) Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Saint Louis University Cancer Center ( Site 0209) Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| New York Medical College ( Site 0215) Coordinator of this site? Confirm its status | Valhalla | United States | Unknown status |
| Georgetown University Medical Center ( Site 0204) Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Innovative Clinical Research Institute ( Site 0202) Coordinator of this site? Confirm its status | Whittier | United States | Unknown status |
| Ankara University Hospital Cebeci-hematology ( Site 2300) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Hacettepe Universitesi-Department of Hematology ( Site 2302) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Mega Medipol-Hematology ( Site 2308) Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Dokuz Eylül Üniversitesi-Hematology ( Site 2304) Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Ondokuz Mayıs Universitesi ( Site 2306) Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Unknown status |
| Karadeniz Teknik Universitesi Tip Fakultesi-Hematology ( Site 2307) Coordinator of this site? Confirm its status | Trabzon | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.