Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT05458297

PHASE2

A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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)).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

223

Start Date

2022-07-21

Completion Date

2029-05-17

Last Updated

2026-03-12

Healthy Volunteers

Conditions

Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Follicular Lymphoma Richter Transformation Lymphoma

Interventions

BIOLOGICAL

Zilovertamab vedotin

IV infusion

DRUG

Nemtabrutinib

Oral tablet

The main inclusion criteria include, but are not limited to the following: Inclusion Criteria: * 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. Exclusion Criteria: * 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 pericardial effusion or clinically significant pleural effusion. * Has ongoing Grade \>1 peripheral neuropathy. * 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. * Participants with FL who have transformed to a more aggressive type of lymphoma. * 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. * Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma. * 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. * For Cohort C only: has any clinically significant gastrointestinal abnormalities that might alter absorption.

Locations (109)

Alaska Oncology and Hematology ( Site 0037)

Anchorage, Alaska, United States

Banner MD Anderson Cancer Center ( Site 0040)

Gilbert, Arizona, United States

Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036)

Phoenix, Arizona, United States

University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008)

Aurora, Colorado, United States

Cancer Care Specialists of Illinois ( Site 0031)

Decatur, Illinois, United States

University of Kansas Medical Center-Division of Hematologic Malignancies and Cellular Therapeutics ( Site 0038)

Fairway, Kansas, United States

Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007)

Saint Matthews, Kentucky, United States

Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010)

Baltimore, Maryland, United States

Tufts Medical Center ( Site 0024)

Boston, Massachusetts, United States

Massachusetts General Hospital ( Site 0018)

Boston, Massachusetts, United States

Dana-Farber Cancer Institute-Lymphoma ( Site 0026)

Boston, Massachusetts, United States

University of Michigan ( Site 0009)

Ann Arbor, Michigan, United States

Henry Ford Hospital ( Site 0035)

Detroit, Michigan, United States

Icahn School of Medicine at Mount Sinai ( Site 0023)

New York, New York, United States

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0014)

Fargo, North Dakota, United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0004)

Columbus, Ohio, United States

Avera Cancer Institute- Research ( Site 0011)

Sioux Falls, South Dakota, United States

Medical Oncology Associates, PS ( Site 0005)

Spokane, Washington, United States

University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030)

Madison, Wisconsin, United States

Medical College of Wisconsin ( Site 0021)

Milwaukee, Wisconsin, United States

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1807)

Natal, Rio Grande do Norte, Brazil

Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Site 1809)

Rio de Janeiro, Brazil

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1808)

São Paulo, Brazil

Hospital Paulistano-Americas Oncologia ( Site 1805)

São Paulo, Brazil

BC Cancer Vancouver-Clinical Trials Unit ( Site 0201)

Vancouver, British Columbia, Canada

The Moncton Hospital-Oncology ( Site 0211)

Moncton, New Brunswick, Canada

QEII Health Sciences Centre - Victoria General Site ( Site 0213)

Halifax, Nova Scotia, Canada

London Health Sciences Centre ( Site 0203)

London, Ontario, Canada

Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)

Toronto, Ontario, Canada

Jewish General Hospital ( Site 0202)

Montreal, Quebec, Canada

Allan Blair Cancer Centre-Care Services ( Site 0208)

Regina, Saskatchewan, Canada

IC La Serena Research ( Site 1909)

La Serena, Coquimbo Region, Chile

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1907)

Santiago, Region M. de Santiago, Chile

Clínica Inmunocel ( Site 1910)

Santiago, Region M. de Santiago, Chile

Clínica Alemana de Santiago ( Site 1903)

Santiago, Region M. de Santiago, Chile

Beijing Cancer hospital ( Site 1200)

Beijing, Beijing Municipality, China

Zhujiang Hospital ( Site 1207)

Guangzhou, Guangdong, China

Southern Medical University Nanfang Hospital ( Site 1202)

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center ( Site 1201)

Guangzhou, Guangdong, China

Henan Cancer Hospital-hematology department ( Site 1212)

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1210)

Wuhan, Hubei, China

Tongji Hospital Tongji Medical,Science & Technology ( Site 1221)

Wuhan, Hubei, China

The First Affiliated Hospital of Soochow University-hematology department ( Site 1218)

Suzhou, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical College ( Site 1223)

Xuzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University ( Site 1204)

Nanchang, Jiangxi, China

Jiangxi Provincial Cancer Hospital ( Site 1213)

Nanchang, Jiangxi, China

Jilin Province Tumor Hospital-oncology department ( Site 1220)

Chuangchun, Jilin, China

Fudan University Shanghai Cancer Center ( Site 1208)

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University-Head and Neck Oncology ( Site 1206)

Chengdu, Sichuan, China

The First Affiliated Hospital, Zhejiang University ( Site 1211)

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 1214)

Hangzhou, Zhejiang, China

Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0300)

Brno, Brno-mesto, Czechia

Fakultni nemocnice Ostrava-Klinika Hematoonkologie ( Site 0301)

Ostrava, Moravskoslezský kraj, Czechia

Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)

Prague, Czechia

North Estonia Medical Centre Foundation ( Site 0401)

Tallinn, Harju, Estonia

Universitaetsklinikum Ulm. ( Site 0502)

Ulm, Baden-Wurttemberg, Germany

Universitaetsklinikum Koeln ( Site 0506)

Cologne, North Rhine-Westphalia, Germany

St. James's Hospital ( Site 0600)

Dublin, Ireland

Emek Medical Center-Hematology Unit ( Site 0705)

Afula, Israel

Soroka Medical Center-Hematology Department ( Site 0707)

Beersheba, Israel

Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 0706)

Haifa, Israel

Carmel Hospital ( Site 0709)

Haifa, Israel

Hadassah Medical Center ( Site 0701)

Jerusalem, Israel

Galilee Medical Center ( Site 0710)

Nahariya, Israel

Sheba Medical Center-Hemato Oncology ( Site 0700)

Ramat Gan, Israel

IRCCS - AOU di Bologna-SSD: Diagnosi e terapie dei linfomi e delle sindromi linfoproliferative cron ( Site 0800)

Bologna, Emilia-Romagna, Italy

Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0802)

Rozzano, Milano, Italy

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant ( Site 0803)

Alessandria, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 0804)

Roma, Italy

National Hospital Organization Nagoya Medical Center ( Site 1108)

Nagoya, Aichi-ken, Japan

Hokkaido University Hospital ( Site 1104)

Sapporo, Hokkaido, Japan

Tokai University Hospital ( Site 1100)

Isehara, Kanagawa, Japan

Tohoku University Hospital ( Site 1106)

Sendai, Miyagi, Japan

Kindai University Hospital ( Site 1102)

Sakai, Osaka, Japan

National Cancer Center Hospital ( Site 1103)

Chuo-ku, Tokyo, Japan

Cancer Institute Hospital of JFCR ( Site 1101)

Koto, Tokyo, Japan

Kyushu University Hospital ( Site 1105)

Fukuoka, Japan

Okayama University Hospital ( Site 1107)

Okayama, Japan

Centro Medico Monte Carmelo ( Site 1702)

Arequipa, Ariqipa, Peru

INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 1700)

Lima, Peru

Pratia MCM Krakow ( Site 1001)

Krakow, Lesser Poland Voivodeship, Poland

Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologiczny ( Site 1006)

Lublin, Lublin Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 1002)

Warsaw, Masovian Voivodeship, Poland

Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1007)

Olsztyn, Warmian-Masurian Voivodeship, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 1008)

Lodz, Łódź Voivodeship, Poland

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 1010)

Kielce, Świętokrzyskie Voivodeship, Poland

Champalimaud Foundation ( Site 2002)

Lisbon, Lisbon District, Portugal

Unidade Local de Saude de Braga - Hospital de Braga ( Site 2001)

Braga, Portugal

Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2000)

Porto, Portugal

National Cancer Centre Singapore ( Site 1500)

Singapore, Central Singapore, Singapore

Seoul National University Hospital ( Site 1300)

Seoul, South Korea

Samsung Medical Center ( Site 1301)

Seoul, South Korea

Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4003)

L'Hospitalet Del Llobregat, Barcelona, Spain

Hospital Universitari Vall d'Hebron ( Site 4004)

Barcelona, Catalonia, Spain

MD Anderson Cancer Center ( Site 4006)

Madrid, Madrid, Comunidad de, Spain

Clinica Universidad de Navarra ( Site 4005)

Pamplona, Navarre, Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( Site 4001)

Salamanca, Spain

Skånes Universitetssjukhus Lund ( Site 5000)

Lund, Skåne County, Sweden

Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 5002)

Uppsala, Uppsala County, Sweden

Sahlgrenska Universitetssjukhuset ( Site 5003)

Gothenburg, Västra Götaland County, Sweden

Mega Medipol-Hematology ( Site 6009)

Stanbul, Istanbul, Turkey (Türkiye)

Ege Universitesi Hastanesi ( Site 6002)

Bornova, İzmir, Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 6001)

Ankara, Turkey (Türkiye)

Trakya University ( Site 6005)

Edirne, Turkey (Türkiye)

Ondokuz Mayıs Universitesi-Oncology department ( Site 6004)

Samsun, Turkey (Türkiye)

The Royal Cornwall Hospital-Haematology ( Site 7006)

Truro, Cornwall, United Kingdom

University College London Hospital ( Site 7001)

London, London, City of, United Kingdom

The Churchill Hospital ( Site 7002)

Oxford, Oxfordshire, United Kingdom

The Christie NHS Foundation Trust ( Site 7007)

Manchester, United Kingdom

Clinical Research Directory

A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (109)