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

April 19, 2024 updated by: Merck Sharp & Dohme LLC

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

275

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Recruiting
        • Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 (
        • Contact:
          • Study Coordinator
          • Phone Number: +552199616963
      • Sao Paulo, Brazil, 01321-001
        • Recruiting
        • Hospital Paulistano-Americas Oncologia ( Site 1805)
        • Contact:
          • Study Coordinator
          • Phone Number: +551130161075
    • Rio Grande Do Norte
      • Natal, Rio Grande Do Norte, Brazil, 59075-740
        • Recruiting
        • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1807)
        • Contact:
          • Study Coordinator
          • Phone Number: 84 999278442
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01246-000
        • Recruiting
        • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1808)
        • Contact:
          • Study Coordinator
          • Phone Number: +5511 4573-7631
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BC Cancer Vancouver-Clinical Trials Unit ( Site 0201)
        • Contact:
          • Study Coordinator
          • Phone Number: 6048776000672017
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Recruiting
        • The Moncton Hospital-Oncology ( Site 0211)
        • Contact:
          • Study Coordinator
          • Phone Number: 5068702404
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • QEII Health Sciences Centre - Victoria General Site ( Site 0213)
        • Contact:
          • Study Coordinator
          • Phone Number: 9024737006
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Lawson Health Research Institute - London Health Sciences Ce-London Regional Cancer Program ( Site 0
        • Contact:
          • Study Coordinator
          • Phone Number: 519685850075017
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)
        • Contact:
          • Study Coordinator
          • Phone Number: 41694645012821
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: 514340822224572
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Recruiting
        • Allan Blair Cancer Centre-Care Services ( Site 0208)
        • Contact:
          • Study Coordinator
          • Phone Number: 3063514450
  • Chile
    • Coquimbo
      • La Serena, Coquimbo, Chile, 1720430
        • Recruiting
        • IC La Serena Research ( Site 1909)
        • Contact:
          • Study Coordinator
          • Phone Number: +56993718661
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 7500653
        • Recruiting
        • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1907)
        • Contact:
          • Study Coordinator
          • Phone Number: +56991612199
      • Santiago, Region M. De Santiago, Chile, 7650568
        • Recruiting
        • Clínica Alemana de Santiago ( Site 1903)
        • Contact:
          • Study Coordinator
          • Phone Number: 56992794676
  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer hospital ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: +8601088196118
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: 13798101121
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • Zhujiang Hospital ( Site 1207)
        • Contact:
          • Study Coordinator
          • Phone Number: 13430200803
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University Nanfang Hospital ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: 020-61641888
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital-hematology department ( Site 1212)
        • Contact:
          • Study Coordinator
          • Phone Number: 0371-65588007
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1210)
        • Contact:
          • Study Coordinator
          • Phone Number: 15871725926
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital Tongji Medical,Science & Technology ( Site 1221)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 131 3569 1993
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • The First Affiliated Hospital of Soochow University-hematology department ( Site 1218)
        • Contact:
          • Study Coordinator
          • Phone Number: 13616219570
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical College ( Site 1223)
        • Contact:
          • Study Coordinator
          • Phone Number: 13813282842
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: 13970038386
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jiangxi Provincial Cancer Hospital ( Site 1213)
        • Contact:
          • Study Coordinator
          • Phone Number: 13607045741
    • Jilin
      • Changchun, Jilin, China, 132000
        • Recruiting
        • Jilin Province Tumor Hospital-oncology department ( Site 1220)
        • Contact:
          • Study Coordinator
          • Phone Number: 13843126796
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center ( Site 1208)
        • Contact:
          • Study Coordinator
          • Phone Number: 18017312613
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University-Head and Neck Oncology ( Site 1206)
        • Contact:
          • Study Coordinator
          • Phone Number: +8618980601027
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital ( Site 1214)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613857182590
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University ( Site 1211)
        • Contact:
          • Study Coordinator
          • Phone Number: 13857190311
  • Czechia
      • Praha 2, Czechia, 128 08
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +420 224 962 527
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 62500
        • Recruiting
        • Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: 420532233642
    • Moravskoslezsky Kraj
      • Ostrava, Moravskoslezsky Kraj, Czechia, 708 52
        • Recruiting
        • Fakultni nemocnice Ostrava-Klinika Hematoonkologie ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: 420597372091
  • Estonia
    • Harjumaa
      • Tallinn, Harjumaa, Estonia, 13419
        • Recruiting
        • North Estonia Medical Centre Foundation ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: +3726172177
  • Germany
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: +49731/5000
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • Recruiting
        • Universitaetsklinikum Koeln ( Site 0506)
        • Contact:
          • Study Coordinator
          • Phone Number: 004922147897046
  • Ireland
      • Dublin, Ireland, D08 E9P6
        • Recruiting
        • St. James's Hospital ( Site 0600)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 (01) 410 3754
  • Israel
      • Afula, Israel, 1834111
        • Recruiting
        • Emek Medical Center-Hematology Unit ( Site 0705)
        • Contact:
          • Study Coordinator
          • Phone Number: +972 4 6495437
      • Be'er Sheva, Israel, 8410101
        • Recruiting
        • Soroka Medical Center-Hematology Department ( Site 0707)
        • Contact:
          • Study Coordinator
          • Phone Number: 97286403827
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 0706)
        • Contact:
          • Study Coordinator
          • Phone Number: +972502061259
      • Haifa, Israel, 3436212
        • Recruiting
        • Carmel Hospital ( Site 0709)
        • Contact:
          • Study Coordinator
          • Phone Number: +97248250844
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: 97226778180
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center-Hemato Oncology ( Site 0700)
        • Contact:
          • Study Coordinator
          • Phone Number: +972526667154
  • Italy
      • Alessandria, Italy, 15121
        • Completed
        • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Recruiting
        • IRCCS - AOU di Bologna-SSD: Diagnosi e terapie dei linfomi e delle sindromi linfoproliferative cron
        • Contact:
          • Study Coordinator
          • Phone Number: +390516363680
    • Lazio
      • Roma, Lazio, Italy, oo168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 0804)
        • Contact:
          • Study Coordinator
          • Phone Number: +390630154180
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0802)
        • Contact:
          • Study Coordinator
          • Phone Number: 390282244080
  • Japan
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-92-641-1151
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital ( Site 1107)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-86-223-7151
    • Aichi
      • Nagoya, Aichi, Japan, 460-0001
        • Recruiting
        • National Hospital Organization Nagoya Medical Center ( Site 1108)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-52-951-1111
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-716-1161
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Recruiting
        • Tokai University Hospital- Isehara Campus ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-463-93-1121
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital ( Site 1106)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-717-7000
    • Osaka
      • Osaka-sayama, Osaka, Japan, 589-8511
        • Recruiting
        • Kindai University Hospital- Osakasayama Campus ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-366-0221
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3542-2511
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Japanese Foundation for Cancer Research ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3520-0111
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220721672
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: +82221487390
  • Peru
      • Lima, Peru, 15038
        • Recruiting
        • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 1700)
        • Contact:
          • Study Coordinator
          • Phone Number: +51989310502
  • Poland
    • Lodzkie
      • Łódź, Lodzkie, Poland, 93-513
        • Completed
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 1008)
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-090
        • Recruiting
        • Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologiczny ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 81 454 1221
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-727
        • Recruiting
        • Pratia MCM Krakow ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: +48602338290
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
        • Contact:
          • Study Coordinator
          • Phone Number: +48225462223
    • Warminsko-mazurskie
      • Olsztyn, Warminsko-mazurskie, Poland, 10-228
        • Recruiting
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Sit
        • Contact:
          • Study Coordinator
          • Phone Number: +485398757
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • 2CA BRAGA ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: +351253027249
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: +351 22 508 4000
    • Lisboa
      • Lisbon, Lisboa, Portugal, 1400-038
        • Recruiting
        • Champalimaud Foundation ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: +351210480200
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore ( Site 1500)
        • Contact:
          • Study Coordinator
          • Phone Number: +6564368000
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron ( Site 4004)
        • Contact:
          • Study Coordinator
          • Phone Number: 0034932746000
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( S
        • Contact:
          • Study Coordinator
          • Phone Number: +34923291100 ext 56606
    • Barcelona
      • L'Hospitalet Del Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4003)
        • Contact:
          • Study Coordinator
          • Phone Number: 0034932607750
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra ( Site 4005)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 948 396 297
  • Sweden
    • Skane Lan
      • Lund, Skane Lan, Sweden, 22185
        • Recruiting
        • Skånes Universitetssjukhus Lund ( Site 5000)
        • Contact:
          • Study Coordinator
          • Phone Number: 0046 (0)46177520
    • Uppsala Lan
      • Uppsala, Uppsala Lan, Sweden, 751 85
        • Recruiting
        • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 5002)
        • Contact:
          • Study Coordinator
          • Phone Number: 0046 (0)186110000
    • Vastra Gotalands Lan
      • Gothenburg, Vastra Gotalands Lan, Sweden, 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset ( Site 5003)
        • Contact:
          • Study Coordinator
          • Phone Number: 46723878081
  • Turkey
      • Ankara, Turkey, 06100
        • Recruiting
        • Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 6001)
        • Contact:
          • Study Coordinator
          • Phone Number: 0 312 595 74 82
      • Edirne, Turkey, 22030
        • Recruiting
        • Trakya University ( Site 6005)
        • Contact:
          • Study Coordinator
          • Phone Number: +905335544797
      • Samsun, Turkey, 55139
        • Recruiting
        • Ondokuz Mayıs Universitesi-Oncology department ( Site 6004)
        • Contact:
          • Study Coordinator
          • Phone Number: 905324412859
      • İzmir, Turkey, 35100
        • Recruiting
        • Ege Universitesi Hastanesi ( Site 6002)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 232 343 43 43
    • Istanbul
      • Stanbul, Istanbul, Turkey, 34214
        • Recruiting
        • Mega Medipol-Hematology ( Site 6009)
        • Contact:
          • Study Coordinator
          • Phone Number: +905437870708
  • United Kingdom
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Recruiting
        • The Royal Cornwall Hospital-Haematology ( Site 7006)
        • Contact:
          • Study Coordinator
          • Phone Number: +44 (0) 1872 250000
    • England
      • London, England, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospital ( Site 7001)
        • Contact:
          • Study Coordinator
          • Phone Number: +44 20 3447 9320
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Recruiting
        • The Churchill Hospital ( Site 7002)
        • Contact:
          • Study Coordinator
          • Phone Number: +44 (0)1865 617331
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Oncology and Hematology ( Site 0037)
        • Contact:
          • Study Coordinator
          • Phone Number: 907-257-9851
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036)
        • Contact:
          • Study Coordinator
          • Phone Number: 602-521-3700
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008
        • Contact:
          • Study Coordinator
          • Phone Number: 206-963-7643
    • Illinois
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois ( Site 0031)
        • Contact:
          • Study Coordinator
          • Phone Number: 217-690-7045
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Medical Center-Division of Hematologic Malignancies and Cellular Therapeutics (
        • Contact:
          • Study Coordinator
          • Phone Number: 913-574-2650
    • Kentucky
      • Saint Matthews, Kentucky, United States, 40207
        • Recruiting
        • Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007)
        • Contact:
          • Study Coordinator
          • Phone Number: 502-899-3366
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010)
        • Contact:
          • Study Coordinator
          • Phone Number: 410-328-3689
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital ( Site 0018)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-571-3037
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute-Lymphoma ( Site 0026)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-632-6844
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center ( Site 0024)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-591-1770
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan ( Site 0009)
        • Contact:
          • Study Coordinator
          • Phone Number: 908-337-8293
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital ( Site 0035)
        • Contact:
          • Study Coordinator
          • Phone Number: 313-916-1784
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai ( Site 0023)
        • Contact:
          • Study Coordinator
          • Phone Number: 347-263-1843
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Recruiting
        • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0014)
        • Contact:
          • Study Coordinator
          • Phone Number: 701-234-2000
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
        • Contact:
          • Study Coordinator
          • Phone Number: 614-371-7022
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute- Research ( Site 0011)
        • Contact:
          • Study Coordinator
          • Phone Number: 267-844-7119
    • Washington
      • Spokane, Washington, United States, 99208
        • Recruiting
        • Medical Oncology Associates, PS ( Site 0005)
        • Contact:
          • Study Coordinator
          • Phone Number: 509-462-2273
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030)
        • Contact:
          • Study Coordinator
          • Phone Number: 608-262-9317
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • MEDICAL COLLEGE OF WISCONSIN ( Site 0021)
        • Contact:
          • Study Coordinator
          • Phone Number: 501-218-3305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

The main inclusion criteria include, but are not limited to the following:

Inclusion Criteria:

  • For aggressive B-cell malignancies 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 FL and 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 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.
  • Active HBV or hepatitis C virus (HCV) infection.
  • For Cohort C only: has any clinically significant gastrointestinal abnormalities that might alter absorption.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
Participants will receive zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) until disease progression or discontinuation.
Biological: Zilovertamab vedotin
IV infusion
Other Names:
  • MK-2140
Experimental: Cohort B
Participants will receive zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) until disease progression or discontinuation.
Biological: Zilovertamab vedotin
IV infusion
Other Names:
  • MK-2140
Experimental: Cohort C
Participants will receive zilovertamab vedotin every 3 weeks (Q3W) combined with nemtabrutinib daily until disease progression or discontinuation.
Biological: Zilovertamab vedotin
IV infusion
Other Names:
  • MK-2140
Drug: Nemtabrutinib
65 mg once daily (QD) orally
Other Names:
  • MK-1026
Experimental: Cohort D
Participants will receive either zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) or 2.0 mg/kg with infusions on Days 1 and 8 of each 3 week cycle (Q2/3W) until disease progression or discontinuation.
Biological: Zilovertamab vedotin
IV infusion
Other Names:
  • MK-2140
Experimental: Cohort E
Participants will receive either zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) or 2.0 mg/kg with infusions on Days 1 and 8 of each 3 week cycle (Q2/3W) until disease progression or discontinuation.
Biological: Zilovertamab vedotin
IV infusion
Other Names:
  • MK-2140
Experimental: Cohort F
Participants will receive either zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) or 2.0 mg/kg with infusions on Days 1 and 8 of each 3 week cycle (Q2/3W) until disease progression or discontinuation.
Biological: Zilovertamab vedotin
IV infusion
Other Names:
  • MK-2140

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with ≥1 Adverse Event (AE) [cohort C and D]
Time Frame: Up to approximately 57 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL, FL, and CLL who experienced an AE will be reported.
Up to approximately 57 months
Percentage of Participants Discontinuing from Study Therapy Due to AE (cohort C and D)
Time Frame: Up to approximately 57 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL, FL, and CLL who discontinued study treatment due to an AE will be reported.
Up to approximately 57 months
Percentage of Participants with Dose-Limiting Toxicity (DLT) [cohort C]
Time Frame: Up to approximately 57 months
The Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 will be used to grade the severity of AEs. DLTs for participants with MCL as assessed by investigator will be reported.
Up to approximately 57 months
Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by Blinded Independent Central Review (BICR) [cohorts A, B, E and FL participants in D]
Time Frame: Up to approximately 57 months
ORR, defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano Response Criteria as assessed by BICR will be reported.
Up to approximately 57 months
ORR per Lugano Response Criteria as Assessed by Investigator (cohort C)
Time Frame: Up to approximately 57 months
ORR, defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano Response Criteria as assessed by investigator will be reported.
Up to approximately 57 months
ORR per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as Assessed by Investigator
Time Frame: Up to approximately 57 months
ORR, defined as the percentage of participants who achieve a CR or PR per iwCLL criteria as assessed by investigator will be reported.
Up to approximately 57 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR) per Lugano Response Criteria as Assessed by BICR (cohorts A, B, D (FL), and E)
Time Frame: Up to approximately 57 months
DOR, defined as the time from the first documented evidence of CR or PR per Lugano Response Criteria as assessed by BICR, until disease progression or death due to any cause, whichever occurs first, will be reported.
Up to approximately 57 months
DOR per Lugano Response Criteria as Assessed by Investigator (cohort C)
Time Frame: Up to approximately 57 months
DOR, defined as the time from the first documented evidence of CR or PR per Lugano Response Criteria as assessed by investigator, until disease progression or death due to any cause, whichever occurs first, will be reported.
Up to approximately 57 months
DOR per iwCLL Criteria as Assessed by Investigator (cohorts D [CLL] and F)
Time Frame: Up to approximately 57 months
DOR, defined as the time from the first documented evidence of CR or PR per iwCLL criteria as assessed by investigator, until disease progression or death due to any cause, whichever occurs first, will be reported.
Up to approximately 57 months
Percentage of Participants with ≥1 AE (cohorts A, B, E, and F)
Time Frame: Up to approximately 57 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL, RTL, FL, and CLL who experienced an AE will be reported.
Up to approximately 57 months
Percentage of Participants Discontinuing from Study Therapy Due to AE (cohorts A, B, E, and F)
Time Frame: Up to approximately 57 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL, RTL, FL, and CLL who discontinued study treatment due to an AE will be reported.
Up to approximately 57 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2022

Primary Completion (Estimated)

March 13, 2027

Study Completion (Estimated)

April 26, 2027

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2140-006
  • MK-2140-006 (Other Identifier: Merck)
  • 2021-004450-36 (EudraCT Number)
  • jRCT2011230019 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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