Chronic Lymphocytic Leukemia Clinical Trial

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

Summary

The purpose of this study is to assess the safety and tolerability of zilovertamab vedotin as monotherapy and in combination with nemtabrutinib in participants with select B-cell lymphomas including mantle cell lymphoma (MCL), Richter's transformation lymphoma (RTL), follicular lymphoma (FL), and leukemia-cll/" >chronic lymphocytic leukemia (CLL). This study will also evaluate zilovertamab vedotin as monotherapy and in combination with nemtabrutinib with respect to objective response rate.

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
RT: relapsed or refractory disease after at least 1 prior systemic therapy
MCL: relapsed or refractory disease after at least 1 prior systemic therapy and no prior exposure to a non-covalent BTKi
FL and CLL: relapsed or refractory disease 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).

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

275

Study ID:

NCT05458297

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 104 Locations for this study

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Alaska Oncology and Hematology ( Site 0037)
Anchorage Alaska, 99508, United States More Info
Study Coordinator
Contact
907-257-9851
Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036)
Phoenix Arizona, 85006, United States More Info
Study Coordinator
Contact
602-521-3700
University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008
Aurora Colorado, 80045, United States More Info
Study Coordinator
Contact
206-963-7643
Cancer Care Specialists of Illinois ( Site 0031)
Decatur Illinois, 62526, United States More Info
Study Coordinator
Contact
217-690-7045
University of Kansas Medical Center-Division of Hematologic Malignancies and Cellular Therapeutics (
Fairway Kansas, 66205, United States More Info
Study Coordinator
Contact
913-574-2650
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007)
Saint Matthews Kentucky, 40207, United States More Info
Study Coordinator
Contact
502-899-3366
Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010)
Baltimore Maryland, 21201, United States More Info
Study Coordinator
Contact
410-328-3689
Tufts Medical Center ( Site 0024)
Boston Massachusetts, 02111, United States More Info
Study Coordinator
Contact
646-591-1770
Massachusetts General Hospital ( Site 0018)
Boston Massachusetts, 02114, United States More Info
Study Coordinator
Contact
617-571-3037
Dana-Farber Cancer Institute-Lymphoma ( Site 0026)
Boston Massachusetts, 02215, United States More Info
Study Coordinator
Contact
617-632-6844
University of Michigan ( Site 0009)
Ann Arbor Michigan, 48109, United States More Info
Study Coordinator
Contact
908-337-8293
Henry Ford Hospital ( Site 0035)
Detroit Michigan, 48202, United States More Info
Study Coordinator
Contact
313-916-1784
Icahn School of Medicine at Mount Sinai ( Site 0023)
New York New York, 10029, United States More Info
Study Coordinator
Contact
347-263-1843
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0014)
Fargo North Dakota, 58122, United States More Info
Study Coordinator
Contact
701-234-2000
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
Columbus Ohio, 43210, United States More Info
Study Coordinator
Contact
614-371-7022
Avera Cancer Institute- Research ( Site 0011)
Sioux Falls South Dakota, 57105, United States More Info
Study Coordinator
Contact
267-844-7119
Medical Oncology Associates, PS ( Site 0005)
Spokane Washington, 99208, United States More Info
Study Coordinator
Contact
509-462-2273
University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030)
Madison Wisconsin, 53792, United States More Info
Study Coordinator
Contact
608-262-9317
MEDICAL COLLEGE OF WISCONSIN ( Site 0021)
Milwaukee Wisconsin, 53226, United States More Info
Study Coordinator
Contact
501-218-3305
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1807)
Natal Rio Grande Do Norte, 59075, Brazil More Info
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Contact
84 999278442
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1808)
São Paulo Sao Paulo, 01246, Brazil More Info
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Contact
+5511 4573-7631
Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 (
Rio de Janeiro , 20231, Brazil More Info
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Contact
+552199616963
Hospital Paulistano-Americas Oncologia ( Site 1805)
Sao Paulo , 01321, Brazil More Info
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Contact
+551130161075
BC Cancer Vancouver-Clinical Trials Unit ( Site 0201)
Vancouver British Columbia, V5Z 4, Canada More Info
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Contact
6048776000672017
The Moncton Hospital-Oncology ( Site 0211)
Moncton New Brunswick, E1C 6, Canada More Info
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Contact
5068702404
QEII Health Sciences Centre - Victoria General Site ( Site 0213)
Halifax Nova Scotia, B3H 2, Canada More Info
Study Coordinator
Contact
9024737006
Lawson Health Research Institute - London Health Sciences Ce-London Regional Cancer Program ( Site 0
London Ontario, N6A 5, Canada More Info
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Contact
519685850075017
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)
Toronto Ontario, M5G 2, Canada More Info
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Contact
41694645012821
Jewish General Hospital ( Site 0202)
Montreal Quebec, H3T 1, Canada More Info
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Contact
514340822224572
Allan Blair Cancer Centre-Care Services ( Site 0208)
Regina Saskatchewan, S4T 7, Canada More Info
Study Coordinator
Contact
3063514450
IC La Serena Research ( Site 1909)
La Serena Coquimbo, 17204, Chile More Info
Study Coordinator
Contact
+56993718661
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1907)
Santiago Region M. De Santiago, 75006, Chile More Info
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+56991612199
Clínica Inmunocel ( Site 1910)
Santiago Region M. De Santiago, 75802, Chile More Info
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Contact
+56997890202
Clínica Alemana de Santiago ( Site 1903)
Santiago Region M. De Santiago, 76505, Chile More Info
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Contact
56992794676
Beijing Cancer hospital ( Site 1200)
Beijing Beijing, 10014, China More Info
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Contact
+8601088196118
Zhujiang Hospital ( Site 1207)
Guangzhou Guangdong, 51028, China More Info
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Contact
13430200803
Southern Medical University Nanfang Hospital ( Site 1202)
Guangzhou Guangdong, 51051, China More Info
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Contact
020-61641888
Sun Yat-sen University Cancer Center ( Site 1201)
Guangzhou Guangdong, 51070, China More Info
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Contact
13798101121
Henan Cancer Hospital-hematology department ( Site 1212)
Zhengzhou Henan, 45000, China More Info
Study Coordinator
Contact
0371-65588007
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1210)
Wuhan Hubei, 43001, China More Info
Study Coordinator
Contact
15871725926
Tongji Hospital Tongji Medical,Science & Technology ( Site 1221)
Wuhan Hubei, 43003, China More Info
Study Coordinator
Contact
+86 131 3569 1993
The First Affiliated Hospital of Soochow University-hematology department ( Site 1218)
Suzhou Jiangsu, 21500, China More Info
Study Coordinator
Contact
13616219570
The Affiliated Hospital of Xuzhou Medical College ( Site 1223)
Xuzhou Jiangsu, 22100, China More Info
Study Coordinator
Contact
13813282842
The First Affiliated Hospital of Nanchang University ( Site 1204)
Nanchang Jiangxi, 33000, China More Info
Study Coordinator
Contact
13970038386
Jiangxi Provincial Cancer Hospital ( Site 1213)
Nanchang Jiangxi, 33002, China More Info
Study Coordinator
Contact
13607045741
Jilin Province Tumor Hospital-oncology department ( Site 1220)
Changchun Jilin, 13200, China More Info
Study Coordinator
Contact
13843126796
Fudan University Shanghai Cancer Center ( Site 1208)
Shanghai Shanghai, 20003, China More Info
Study Coordinator
Contact
18017312613
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 1206)
Cheng Du Sichuan, 61004, China More Info
Study Coordinator
Contact
+8618980601027
The First Affiliated Hospital, Zhejiang University ( Site 1211)
Hangzhou Zhejiang, 31000, China More Info
Study Coordinator
Contact
13857190311
Zhejiang Cancer Hospital ( Site 1214)
Hangzhou Zhejiang, 31002, China More Info
Study Coordinator
Contact
8613857182590
Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0300)
Brno Brno-mesto, 62500, Czechia More Info
Study Coordinator
Contact
420532233642
Fakultni nemocnice Ostrava-Klinika Hematoonkologie ( Site 0301)
Ostrava Moravskoslezsky Kraj, 708 5, Czechia More Info
Study Coordinator
Contact
420597372091
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)
Praha 2 , 128 0, Czechia More Info
Study Coordinator
Contact
+420 224 962 527
North Estonia Medical Centre Foundation ( Site 0401)
Tallinn Harjumaa, 13419, Estonia More Info
Study Coordinator
Contact
+3726172177
Universitaetsklinikum Ulm ( Site 0502)
Ulm Baden-Wurttemberg, 89081, Germany More Info
Study Coordinator
Contact
+49731/5000
Universitaetsklinikum Koeln ( Site 0506)
Köln Nordrhein-Westfalen, 50937, Germany More Info
Study Coordinator
Contact
004922147897046
St. James's Hospital ( Site 0600)
Dublin , D08 E, Ireland More Info
Study Coordinator
Contact
+33 (01) 410 3754
Emek Medical Center-Hematology Unit ( Site 0705)
Afula , 18341, Israel More Info
Study Coordinator
Contact
+972 4 6495437
Soroka Medical Center-Hematology Department ( Site 0707)
Be'er Sheva , 84101, Israel More Info
Study Coordinator
Contact
97286403827
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 0706)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
+972502061259
Carmel Hospital ( Site 0709)
Haifa , 34362, Israel More Info
Study Coordinator
Contact
+97248250844
Hadassah Medical Center ( Site 0701)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
97226778180
Sheba Medical Center-Hemato Oncology ( Site 0700)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
+972526667154
IRCCS - AOU di Bologna-SSD: Diagnosi e terapie dei linfomi e delle sindromi linfoproliferative cron
Bologna Emilia-Romagna, 40138, Italy More Info
Study Coordinator
Contact
+390516363680
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 0804)
Roma Lazio, 00168, Italy More Info
Study Coordinator
Contact
+390630154180
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0802)
Rozzano Milano, 20089, Italy More Info
Study Coordinator
Contact
390282244080
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant
Alessandria , 15121, Italy
National Hospital Organization Nagoya Medical Center ( Site 1108)
Nagoya Aichi, 460-0, Japan More Info
Study Coordinator
Contact
+81-52-951-1111
Hokkaido University Hospital ( Site 1104)
Sapporo Hokkaido, 060-8, Japan More Info
Study Coordinator
Contact
+81-11-716-1161
Tokai University Hospital- Isehara Campus ( Site 1100)
Isehara Kanagawa, 259-1, Japan More Info
Study Coordinator
Contact
+81-463-93-1121
Tohoku University Hospital ( Site 1106)
Sendai-shi Miyagi, 980-8, Japan More Info
Study Coordinator
Contact
+81-22-717-7000
Kindai University Hospital- Osakasayama Campus ( Site 1102)
Osaka-sayama Osaka, 589-8, Japan More Info
Study Coordinator
Contact
+81-72-366-0221
National Cancer Center Hospital ( Site 1103)
Chuo-ku Tokyo, 104-0, Japan More Info
Study Coordinator
Contact
+81-3-3542-2511
Japanese Foundation for Cancer Research ( Site 1101)
Koto Tokyo, 135-8, Japan More Info
Study Coordinator
Contact
+81-3-3520-0111
Kyushu University Hospital ( Site 1105)
Fukuoka , 812-8, Japan More Info
Study Coordinator
Contact
+81-92-641-1151
Okayama University Hospital ( Site 1107)
Okayama , 700-8, Japan More Info
Study Coordinator
Contact
+81-86-223-7151
Seoul National University Hospital ( Site 1300)
Seoul , 03080, Korea, Republic of More Info
Study Coordinator
Contact
+82220721672
Samsung Medical Center ( Site 1301)
Seoul , 06351, Korea, Republic of More Info
Study Coordinator
Contact
+82221487390
Centro Medico Monte Carmelo ( Site 1702)
Arequipa Ariqipa, 04001, Peru More Info
Study Coordinator
Contact
+51980728089
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 1700)
Lima , 15038, Peru More Info
Study Coordinator
Contact
+51989310502
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 1008)
Łódź Lodzkie, 93-51, Poland
Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologiczny ( Site 1006)
Lublin Lubelskie, 20-09, Poland More Info
Study Coordinator
Contact
+48 81 454 1221
Pratia MCM Krakow ( Site 1001)
Krakow Malopolskie, 30-72, Poland More Info
Study Coordinator
Contact
+48602338290
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
Warszawa Mazowieckie, 02-78, Poland More Info
Study Coordinator
Contact
+48225462223
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Sit
Olsztyn Warminsko-mazurskie, 10-22, Poland More Info
Study Coordinator
Contact
+485398757
Champalimaud Foundation ( Site 2002)
Lisbon Lisboa, 1400-, Portugal More Info
Study Coordinator
Contact
+351210480200
2CA BRAGA ( Site 2001)
Braga , 4710-, Portugal More Info
Study Coordinator
Contact
+351253027249
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2000)
Porto , 4200-, Portugal More Info
Study Coordinator
Contact
+351 22 508 4000
National Cancer Centre Singapore ( Site 1500)
Singapore Central Singapore, 16858, Singapore More Info
Study Coordinator
Contact
+6564368000
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4003)
L'Hospitalet Del Llobregat Barcelona, 08908, Spain More Info
Study Coordinator
Contact
0034932607750
Hospital Universitari Vall d'Hebron ( Site 4004)
Barcelona Cataluna, 08035, Spain More Info
Study Coordinator
Contact
0034932746000
Clinica Universidad de Navarra ( Site 4005)
Pamplona Navarra, 31008, Spain More Info
Study Coordinator
Contact
34 948 396 297
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( S
Salamanca , 37007, Spain More Info
Study Coordinator
Contact
+34923291100 ext 56606
Skånes Universitetssjukhus Lund ( Site 5000)
Lund Skane Lan, 22185, Sweden More Info
Study Coordinator
Contact
0046 (0)46177520
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 5002)
Uppsala Uppsala Lan, 751 8, Sweden More Info
Study Coordinator
Contact
0046 (0)186110000
Sahlgrenska Universitetssjukhuset ( Site 5003)
Gothenburg Vastra Gotalands Lan, 413 4, Sweden More Info
Study Coordinator
Contact
46723878081
Mega Medipol-Hematology ( Site 6009)
Stanbul Istanbul, 34214, Turkey More Info
Study Coordinator
Contact
+905437870708
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 6001)
Ankara , 06100, Turkey More Info
Study Coordinator
Contact
0 312 595 74 82
Trakya University ( Site 6005)
Edirne , 22030, Turkey More Info
Study Coordinator
Contact
+905335544797
Ege Universitesi Hastanesi ( Site 6002)
İzmir , 35100, Turkey More Info
Study Coordinator
Contact
+90 232 343 43 43
Ondokuz Mayıs Universitesi-Oncology department ( Site 6004)
Samsun , 55139, Turkey More Info
Study Coordinator
Contact
905324412859
The Royal Cornwall Hospital-Haematology ( Site 7006)
Truro Cornwall, TR1 3, United Kingdom More Info
Study Coordinator
Contact
+44 (0) 1872 250000
University College London Hospital ( Site 7001)
London England, NW1 2, United Kingdom
The Churchill Hospital ( Site 7002)
Oxford Oxfordshire, OX3 7, United Kingdom More Info
Study Coordinator
Contact
+44 (0)1865 617331

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

275

Study ID:

NCT05458297

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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