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)
Who is this study for? Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
What treatments are being studied? MK-2140 (Zilovertamab Vedotin)
Status: Active_not_recruiting
Location: See all (69) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0229)
Orange
Innovative Clinical Research Institute ( Site 0202)
Whittier
Washington, D.c.
Georgetown University Medical Center ( Site 0204)
Washington D.c.
Georgia
Northside Hospital ( Site 0206)
Atlanta
Illinois
University of Chicago Medical Center ( Site 0207)
Chicago
Indiana
Franciscan St. Francis Health ( Site 0225)
Indianapolis
Massachusetts
Massachusetts General Hospital-Cancer Center Protocol Office ( Site 0203)
Boston
Maryland
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0211)
Baltimore
Michigan
University of Michigan ( Site 0200)
Ann Arbor
Karmanos Cancer Institute ( Site 0216)
Detroit
Missouri
Saint Louis University Cancer Center ( Site 0209)
St Louis
New Jersey
Atlantic Health System Morristown Medical Center ( Site 0213)
Morristown
New York
New York Medical College ( Site 0215)
Valhalla
Ohio
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0217)
Cincinnati
University Hospitals Cleveland Medical Center ( Site 0222)
Cleveland
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
Columbus
Pennsylvania
AHN West Penn Hospital ( Site 0212)
Pittsburgh
South Dakota
Avera Cancer Institute- Research ( Site 0233)
Sioux Falls
Wisconsin
MEDICAL COLLEGE OF WISCONSIN ( Site 0234)
Milwaukee
Other Locations
Canada
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0100)
Toronto
Chile
Clínica Alemana de Santiago ( Site 2704)
Santiago
James Lind Centro de Investigación del Cáncer ( Site 2705)
Temuco
China
Beijing Cancer hospital ( Site 2900)
Beijing
The First Hospital of Jilin University-Hematology ( Site 2910)
Changchun
Hunan Cancer Hospital ( Site 2905)
Changsha
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 2911)
Chengdu
SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal Medicine ( Site 2907)
Guangzhou
The First Affiliated Hospital, Zhejiang University-Bone marrow transplant centre ( Site 2912)
Hangzhou
Fudan University Shanghai Cancer Center ( Site 2908)
Shanghai
Shanghai East Hospital ( Site 2902)
Shanghai
Tianjin Medical University Cancer Institute and Hospital-lymphoma ( Site 2901)
Tianjin
Wuhan Union Hospital ( Site 2906)
Wuhan
Henan Cancer Hospital-hematology department ( Site 2903)
Zhengzhou
Estonia
North Estonia Medical Centre Foundation ( Site 0900)
Tallinn
France
Centre Hospitalier de la Côte Basque ( Site 1002)
Bayonne
Pitie Salpetriere University Hospital-Clinical haematology ( Site 1000)
Paris
Greece
Evangelismos General Hospital of Athens ( Site 1214)
Athens
General Hospital of Athens Laiko-Hematology Department ( Site 1213)
Athens
Israel
Soroka Medical Center-Hematology Department ( Site 1403)
Beersheba
Hadassah Medical Center ( Site 1402)
Jerusalem
Shaare Zedek Medical Center ( Site 1404)
Jerusalem
Sourasky Medical Center ( Site 1400)
Tel Aviv
Italy
IRCCS - AOU di Bologna-Istituto di Ematologia L. e A. Seragnoli ( Site 1500)
Bologna
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa di Ematologia ( Site 1501)
Milan
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1502)
Napoli
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1503)
Rozzano
Norway
Haukeland Universitetssjukehus ( Site 1601)
Bergen
Oslo universitetssykehus, Radiumhospitalet ( Site 1600)
Oslo
Poland
Szpitale Pomorskie Sp. z o. o.-Hematology and Bone Marrow Transplantation Department ( Site 1702)
Gdynia
Pratia Onkologia ( Site 1701)
Katowice
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1707)
Krakow
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
Warsaw
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site
Wroclaw
Republic of Korea
Samsung Medical Center ( Site 0600)
Seoul
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 0601)
Seoul
Spain
Hospital Universitari Vall d'Hebron ( Site 2005)
Barcelona
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 2002)
L'hospitalet Del Llobregat
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 2000)
Madrid
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 2003)
Salamanca
Sweden
Skånes Universitetssjukhus Lund ( Site 2100)
Lund
Karolinska Universitetssjukhuset Solna ( Site 2102)
Solna
Thailand
Faculty of Medicine Siriraj Hospital ( Site 0701)
Bangkok
Maharaj Nakorn Chiang Mai Hospital ( Site 0702)
Muang
Turkey
Ankara University Hospital Cebeci-hematology ( Site 2300)
Ankara
Hacettepe Universitesi-Department of Hematology ( Site 2302)
Ankara
Mega Medipol-Hematology ( Site 2308)
Istanbul
Dokuz Eylül Üniversitesi-Hematology ( Site 2304)
Izmir
Ondokuz Mayıs Universitesi ( Site 2306)
Samsun
Karadeniz Teknik Universitesi Tip Fakultesi-Hematology ( Site 2307)
Trabzon
Time Frame
Start Date: 2022-01-08
Completion Date: 2026-01-09
Participants
Target number of participants: 140
Treatments
Experimental: Arm A
Participants will receive treatment with zilovertamab vedotin 2.5 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks (Q3W)) until documented disease progression or any other discontinuation criterion is met.
Experimental: Arm B
Participants will receive treatment with zilovertamab vedotin 2.25 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks (Q3W)) until documented disease progression or any other discontinuation criterion is met.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC