NCT05458297Active, not recruitingPhase 2
A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)
A Multicenter, Open-label, Phase 2 Basket Study to Evaluate the Safety and Efficacy of MK-2140 as a Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (waveLINE-006)
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
The purpose of this study is to assess the safety and tolerability of zilovertamab vedotin as monotherapy and in combination in participants with select B-cell lymphomas including mantle cell lymphoma (MCL), Richter's transformation lymphoma (RTL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). This study will also evaluate zilovertamab vedotin as monotherapy and in combination with respect to objective response rate. * Cohort A: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton's tyrosine kinase inhibition/inhibitor (BTKi), and post therapy chimeric antigen receptor T (CAR-T) cell therapy or ineligible for CAR-T cell therapy * Cohort B: Participants with relapsed or refractory RT disease after at least 1 prior systemic therapy * Cohort C: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 1 prior systemic therapy and no prior exposure to a non-covalent BTKi * Cohort D: Participants with relapsed or refractory FL and CLL relapsed or refractory disease after at least 2 prior systemic therapies and have no other available therapy * Cohort E: Participants with relapsed or refractory FL after at least 2 prior systemic therapies and have no other available therapy The primary study hypothesis is that zilovertamab vedotin monotherapy has an increased Objective Response Rate (ORR) per Lugano Response Criteria as assessed by blinded independent central review (BICR). As of Amendment 07, Cohort D is closed to enrollment of participants with CLL and enrollment of participants into Arm 2 (zilovertamab vedotin at Dose 2 on Days 1 \& 8 of each 3 Week Cycle (Q2/3W)). As of Amendment 09, no additional participants with RT will be enrolled in Cohort B; however, those currently enrolled will continue with study intervention treatment (if applicable) until a protocol specified discontinuation criterion is met. Cohort E will be closed, as no participants with FL have been treated in this cohort.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 189 (estimated)
- First submitted
- 11 Jul 2022
- Start date
- 21 Jul 2022
- Primary completion date
- 17 May 2029
- Lead sponsor
- Merck Sharp & Dohme LLC
- NCT number
- NCT05458297
- EU CT number
- 2022-501374-19-00
- EudraCT number
- 2021-004450-36
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 189
- From 21 Jul 2022 to the primary completion date, 17 May 2029
- 105 sites in 21 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 solid organ transplant at any time.
- Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina (\<6 months prior to enrollment), congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication.
- Has received prior systemic anticancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibodies) or 2 weeks (if prior therapy was small molecules like kinase inhibitors) 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.
Other illness
- Has a demyelinating form of Charcot-Marie-Tooth disease.
- 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 not well controlled on antiretroviral therapy (ART)
- Active HBV or hepatitis C virus (HCV) infection.
Other
- Has pericardial effusion or clinically significant pleural effusion.
- Has ongoing Grade \>1 peripheral neuropathy.
- Participants with FL who have transformed to a more aggressive type of lymphoma.
- Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma.
- For Cohort C only: has any clinically significant gastrointestinal abnormalities that might alter absorption.
Who the study is looking for
- For aggressive B-cell malignancies mantle cell lymphoma (MCL): Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton's tyrosine kinase inhibition/inhibitor(s) (BTKi), and is post chimeric antigen receptor T (CAR-T) cell therapy or is ineligible for CAR-T cell therapy.
- For aggressive B-cell malignancies MCL Cohort C: Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease after at least 1 prior systemic therapy and has no prior exposure to a non-covalent BTKi.
- For aggressive B-cell malignancies Richter transformation lymphoma (RTL): Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease.
- For indolent B-cell malignancies follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL): Has histologically confirmed biopsy and has relapsed or refractory disease after at least 2 prior systemic therapies and no other available therapy.
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization/allocation.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before cycle 1 day 1.
Criteria the registry did not label
- The main inclusion criteria include, but are not limited to the following:
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (105)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1807) Coordinator of this site? Confirm its status | Natal | Brazil | Unknown status |
| Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Site 1809) Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1808) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital Paulistano-Americas Oncologia ( Site 1805) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| QEII Health Sciences Centre - Victoria General Site ( Site 0213) Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| London Health Sciences Centre ( Site 0203) Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| The Moncton Hospital-Oncology ( Site 0211) Coordinator of this site? Confirm its status | Moncton | Canada | Unknown status |
| Jewish General Hospital ( Site 0202) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Allan Blair Cancer Centre-Care Services ( Site 0208) Coordinator of this site? Confirm its status | Regina | Canada | Unknown status |
| Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200) Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| BC Cancer Vancouver-Clinical Trials Unit ( Site 0201) Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| IC La Serena Research ( Site 1909) Coordinator of this site? Confirm its status | La Serena | Chile | Unknown status |
| Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1907) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Clínica Alemana de Santiago ( Site 1903) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Clínica Inmunocel ( Site 1910) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Beijing Cancer hospital ( Site 1200) Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital of Sichuan University-Head and Neck Oncology ( Site 1206) Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Jilin Province Tumor Hospital-oncology department ( Site 1220) Coordinator of this site? Confirm its status | Chuangchun | China | Unknown status |
| Sun Yat-sen University Cancer Center ( Site 1201) Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhujiang Hospital ( Site 1207) Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Southern Medical University Nanfang Hospital ( Site 1202) Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhejiang Cancer Hospital ( Site 1214) Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital, Zhejiang University ( Site 1211) Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital of Nanchang University ( Site 1204) Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Jiangxi Provincial Cancer Hospital ( Site 1213) Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Fudan University Shanghai Cancer Center ( Site 1208) Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Affiliated Hospital of Soochow University-hematology department ( Site 1218) Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Tongji Hospital Tongji Medical,Science & Technology ( Site 1221) Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1210) Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The Affiliated Hospital of Xuzhou Medical College ( Site 1223) Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Henan Cancer Hospital-hematology department ( Site 1212) Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Active, not recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Active, not recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | 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 | Active, not recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Active, not recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| University College London Hospital ( Site 7001) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Christie NHS Foundation Trust ( Site 7007) Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| The Churchill Hospital ( Site 7002) Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| The Royal Cornwall Hospital-Haematology ( Site 7006) Coordinator of this site? Confirm its status | Truro | United Kingdom | Unknown status |
| St James's Hospital Coordinator of this site? Confirm its status | Dublin 8 | Ireland | Completed |
| Emek Medical Center-Hematology Unit ( Site 0705) Coordinator of this site? Confirm its status | Afula | Israel | Unknown status |
| Soroka Medical Center-Hematology Department ( Site 0707) Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Carmel Hospital ( Site 0709) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 0706) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Medical Center ( Site 0701) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Galilee Medical Center ( Site 0710) Coordinator of this site? Confirm its status | Nahariya | Israel | Unknown status |
| Sheba Medical Center-Hemato Oncology ( Site 0700) Coordinator of this site? Confirm its status | Ramat Gan | 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 | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Active, not recruiting |
| National Cancer Center Hospital ( Site 1103) Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Kyushu University Hospital ( Site 1105) Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Tokai University Hospital ( Site 1100) Coordinator of this site? Confirm its status | Isehara | Japan | Unknown status |
| Cancer Institute Hospital of JFCR ( Site 1101) Coordinator of this site? Confirm its status | Koto | Japan | Unknown status |
| National Hospital Organization Nagoya Medical Center ( Site 1108) Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Okayama University Hospital ( Site 1107) Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Kindai University Hospital ( Site 1102) Coordinator of this site? Confirm its status | Sakai | Japan | Unknown status |
| Hokkaido University Hospital ( Site 1104) Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Tohoku University Hospital ( Site 1106) Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Samsung Medical Center ( Site 1301) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital ( Site 1300) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Centro Medico Monte Carmelo ( Site 1702) Coordinator of this site? Confirm its status | Arequipa | Peru | Unknown status |
| INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 1700) Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach Coordinator of this site? Confirm its status | Kielce | Poland | Active, not recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Champalimaud Clinical Centre Coordinator of this site? Confirm its status | Lisbon | Portugal | Active, not recruiting |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Active, not recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Active, not recruiting |
| National Cancer Centre Singapore ( Site 1500) Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Alaska Oncology and Hematology ( Site 0037) Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| University of Michigan ( Site 0009) Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008) Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010) Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Tufts Medical Center ( Site 0024) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Dana-Farber Cancer Institute-Lymphoma ( Site 0026) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital ( Site 0018) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0004) Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Cancer Care Specialists of Illinois ( Site 0031) Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Henry Ford Hospital ( Site 0035) Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| University of Kansas Medical Center-Division of Hematologic Malignancies and Cellular Therapeutics ( Site 0038) Coordinator of this site? Confirm its status | Fairway | United States | Unknown status |
| Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0014) Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Banner MD Anderson Cancer Center ( Site 0040) Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030) Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Medical College of Wisconsin ( Site 0021) Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai ( Site 0023) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036) Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007) Coordinator of this site? Confirm its status | Saint Matthews | United States | Unknown status |
| Avera Cancer Institute- Research ( Site 0011) Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Medical Oncology Associates, PS ( Site 0005) Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 6001) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ege Universitesi Hastanesi ( Site 6002) Coordinator of this site? Confirm its status | Bornova | Turkey (Türkiye) | Unknown status |
| Trakya University ( Site 6005) Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Unknown status |
| Ondokuz Mayıs Universitesi-Oncology department ( Site 6004) Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Unknown status |
| Mega Medipol-Hematology ( Site 6009) Coordinator of this site? Confirm its status | Stanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.