Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: 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)
Study ID: NCT05139017
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Innovative Clinical Research Institute ( Site 0122), Whittier, California, United States
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133), Louisville, Kentucky, United States
Louisiana State University Health Sciences Center New Orleans ( Site 0134), New Orleans, Louisiana, United States
University of Maryland ( Site 0123), Baltimore, Maryland, United States
Dana-Farber Cancer Institute-Lymphoma ( Site 0111), Boston, Massachusetts, United States
University of Massachusetts Medical School ( Site 0119), Worcester, Massachusetts, United States
St. Vincent Frontier Cancer Center-Research ( Site 0108), Billings, Montana, United States
Atlantic Health System ( Site 0116), Morristown, New Jersey, United States
New York Medical College ( Site 0113), Valhalla, New York, United States
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0156), Nashville, Tennessee, United States
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200), Toronto, Ontario, Canada
Beijing Cancer hospital ( Site 3000), Beijing, Beijing, China
Chongqing University Cancer Hospital-Medical Oncology ( Site 3025), Chongqing, Chongqing, China
Sun Yat-sen University Cancer Center-Internal Medicine ( Site 3001), Guangzhou, Guangdong, China
Zhujiang Hospital ( Site 3002), Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 3017), Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University ( Site 3004), Nanchang, Jiangxi, China
Jiangxi Provincial Cancer Hospital ( Site 3005), Nanchang, Jiangxi, China
centre hospitalier lyon sud-Service Hématologie ( Site 0702), Pierre-Bénite, Rhone, France
Pitie Salpetriere University Hospital-Clinical haematology ( Site 0700), Paris, , France
Emek Medical Center-Hematology Unit ( Site 1102), Afula, , Israel
Carmel Hospital ( Site 1103), Haifa, , Israel
Hadassah Medical Center ( Site 1100), Jerusalem, , Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 1204), Roma, Lazio, Italy
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1203), Rozzano, Milano, Italy
IRCCS - AOU di Bologna-Istituto di Ematologia "L. e A. Seragnoli" ( Site 1200), Bologna, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1202), Napoli, , Italy
Seoul National University Hospital-Oncology ( Site 0302), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 0300), Seoul, , Korea, Republic of
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site, Wroclaw, Dolnoslaskie, Poland
Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologiczny ( Site 1304), Lublin, Lubelskie, Poland
Pratia MCM Krakow ( Site 1303), Krakow, Malopolskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S, Warszawa, Mazowieckie, Poland
Szpitale Pomorskie Sp. z o. o.-Hematology and Bone Marrow Transplantation Department ( Site 1302), Gdynia, Pomorskie, Poland
Maharaj Nakorn Chiang Mai Hospital ( Site 0401), Muang, Chiang Mai, Thailand
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 0400), Bangkok, Krung Thep Maha Nakhon, Thailand
Ege University Medicine of Faculty ( Site 1902), Bornova, Izmir, Turkey
Ankara University Hospital Cebeci-hematology ( Site 1901), Ankara, , Turkey
Mega Medipol-Hematology ( Site 1909), Istanbul, , Turkey
Dokuz Eylül Üniversitesi-Hematology ( Site 1905), Izmir, , Turkey
Ondokuz Mayıs Universitesi ( Site 1907), Samsun, , Turkey
University College London Hospital-Cancer Clinical Trials Unit ( Site 2100), London-Camden, London, City Of, United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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