Spots Global Cancer Trial Database for A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)
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Trial Identification
Brief Title: A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)
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
Study ID: NCT05458297
Study Description
Brief 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 * Cohort F: Participants with relapsed or refractory CLL 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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Oncology and Hematology ( Site 0037), Anchorage, Alaska, 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 (, 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, 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
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1808), São Paulo, Sao Paulo, Brazil
Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 (, Rio de Janeiro, , Brazil
Hospital Paulistano-Americas Oncologia ( Site 1805), Sao 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
Lawson Health Research Institute - London Health Sciences Ce-London Regional Cancer Program ( Site 0, 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, 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, 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), Changchun, Jilin, China
Fudan University Shanghai Cancer Center ( Site 1208), Shanghai, Shanghai, China
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 1206), Cheng Du, 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, Moravskoslezsky Kraj, Czechia
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302), Praha 2, , Czechia
North Estonia Medical Centre Foundation ( Site 0401), Tallinn, Harjumaa, Estonia
Universitaetsklinikum Ulm ( Site 0502), Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Koeln ( Site 0506), Köln, Nordrhein-Westfalen, 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), Be'er Sheva, , 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
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, Bologna, Emilia-Romagna, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 0804), Roma, Lazio, 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, Alessandria, , Italy
National Hospital Organization Nagoya Medical Center ( Site 1108), Nagoya, Aichi, Japan
Hokkaido University Hospital ( Site 1104), Sapporo, Hokkaido, Japan
Tokai University Hospital- Isehara Campus ( Site 1100), Isehara, Kanagawa, Japan
Tohoku University Hospital ( Site 1106), Sendai-shi, Miyagi, Japan
Kindai University Hospital- Osakasayama Campus ( Site 1102), Osaka-sayama, Osaka, Japan
National Cancer Center Hospital ( Site 1103), Chuo-ku, Tokyo, Japan
Japanese Foundation for Cancer Research ( Site 1101), Koto, Tokyo, Japan
Kyushu University Hospital ( Site 1105), Fukuoka, , Japan
Okayama University Hospital ( Site 1107), Okayama, , Japan
Seoul National University Hospital ( Site 1300), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 1301), Seoul, , Korea, Republic of
Centro Medico Monte Carmelo ( Site 1702), Arequipa, Ariqipa, Peru
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 1700), Lima, , Peru
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 1008), Łódź, Lodzkie, Poland
Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologiczny ( Site 1006), Lublin, Lubelskie, Poland
Pratia MCM Krakow ( Site 1001), Krakow, Malopolskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S, Warszawa, Mazowieckie, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Sit, Olsztyn, Warminsko-mazurskie, Poland
Champalimaud Foundation ( Site 2002), Lisbon, Lisboa, Portugal
2CA 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
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, Cataluna, Spain
Clinica Universidad de Navarra ( Site 4005), Pamplona, Navarra, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( S, Salamanca, , Spain
Skånes Universitetssjukhus Lund ( Site 5000), Lund, Skane Lan, Sweden
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 5002), Uppsala, Uppsala Lan, Sweden
Sahlgrenska Universitetssjukhuset ( Site 5003), Gothenburg, Vastra Gotalands Lan, Sweden
Mega Medipol-Hematology ( Site 6009), Stanbul, Istanbul, Turkey
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 6001), Ankara, , Turkey
Trakya University ( Site 6005), Edirne, , Turkey
Ege Universitesi Hastanesi ( Site 6002), İzmir, , Turkey
Ondokuz Mayıs Universitesi-Oncology department ( Site 6004), Samsun, , Turkey
The Royal Cornwall Hospital-Haematology ( Site 7006), Truro, Cornwall, United Kingdom
University College London Hospital ( Site 7001), London, England, United Kingdom
The Churchill Hospital ( Site 7002), Oxford, Oxfordshire, United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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