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)
研究单位：[1]Merck Sharp & Dohme LLC[2]Innovative Clinical Research Institute ( Site 0122),Whittier,California,United States,90603[3]Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133),Louisville,Kentucky,United States,40207[4]Louisiana State University Health Sciences Center New Orleans ( Site 0134),New Orleans,Louisiana,United States,70112[5]University of Maryland ( Site 0123),Baltimore,Maryland,United States,21201[6]Dana-Farber Cancer Institute-Lymphoma ( Site 0111),Boston,Massachusetts,United States,02215[7]University of Massachusetts Medical School ( Site 0119),Worcester,Massachusetts,United States,01655[8]St. Vincent Frontier Cancer Center-Research ( Site 0108),Billings,Montana,United States,59102[9]Atlantic Health System ( Site 0116),Morristown,New Jersey,United States,07960[10]New York Medical College ( Site 0113),Valhalla,New York,United States,10595[11]Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0156),Nashville,Tennessee,United States,37232[12]Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200),Toronto,Ontario,Canada,M5G 2M9[13]Beijing Cancer hospital ( Site 3000),Beijing,Beijing,China,100142[14]Chongqing University Cancer Hospital-Medical Oncology ( Site 3025),Chongqing,Chongqing,China,400030[15]Chongqing University Three Gorges Hospital ( Site 3026),Chongqing,Chongqing,China,404199[16]Sun Yat-sen University Cancer Center-Internal Medicine ( Site 3001),Guangzhou,Guangdong,China,510030[17]Zhujiang Hospital ( Site 3002),Guangzhou,Guangdong,China,510280[18]Henan Cancer Hospital-hematology department ( Site 3013),Zhengzhou,Henan,China,450008[19]Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 3017),Wuhan,Hubei,China,430010[20]The First Affiliated Hospital of Nanchang University ( Site 3004),Nanchang,Jiangxi,China,330006[21]Jiangxi Provincial Cancer Hospital ( Site 3005),Nanchang,Jiangxi,China,330029[22]The First Hospital of Jilin University-Hematology ( Site 3012),Changchun,Jilin,China,130021[23]Fudan University Shanghai Cancer Center ( Site 3009),Shanghai,Shanghai,China,200032[24]Sichuan Cancer hospital-Oncology ( Site 3021),Chengdu,Sichuan,China,610042[25]centre hospitalier lyon sud-Service Hématologie ( Site 0702),Pierre-Bénite,Rhone,France,69310[26]Pitie Salpetriere University Hospital-Clinical haematology ( Site 0700),Paris,France,75013[27]MEDI-K ( Site 2602),Guatemala,Guatemala,01009[28]Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 2601),Guatemala,Guatemala,01010[29]Queen Mary Hospital ( Site 3100),Hong Kong,Hong Kong,000000[30]Emek Medical Center-Hematology Unit ( Site 1102),Afula,Israel,1834111[31]Carmel Hospital ( Site 1103),Haifa,Israel,3436212[32]Hadassah Medical Center ( Site 1100),Jerusalem,Israel,9112001[33]Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 1204),Roma,Lazio,Italy,00168[34]Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1203),Rozzano,Milano,Italy,20089[35]IRCCS - AOU di Bologna-Istituto di Ematologia ""L. e A. Seragnoli"" ( Site 1200),Bologna,Italy,40138[36]Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1202),Napoli,Italy,80131[37]Seoul National University Hospital-Oncology ( Site 0302),Seoul,Korea, Republic of,03080[38]Samsung Medical Center ( Site 0300),Seoul,Korea, Republic of,06351[39]Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi I Transplantacji Szpiku ( Site,Wroclaw,Dolnoslaskie,Poland,50-367[40]Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologii I Transplantacji Szpiku ( Site 1304),Lublin,Lubelskie,Poland,20-090[41]Pratia MCM Krakow ( Site 1303),Krakow,Malopolskie,Poland,30-727[42]Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S,Warszawa,Mazowieckie,Poland,02-781[43]Szpitale Pomorskie Sp. Z o. o.-Hematolo
研究目的：
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.
