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AzTrials

Chronic Lymphocytic LeukemiaPhase 2NCT05458297

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

A Phase 2 study testing Zilovertamab vedotin and Nemtabrutinib in people with Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, run by Merck Sharp & Dohme LLC at 109 sites in 21 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Zilovertamab vedotin and Nemtabrutinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
109 sitesin 21 countries
Study dates
21 Jul 2022to 17 May 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For aggressive B-cell malignancies mantle cell lymphoma (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 follicular lymphoma (FL) and chronic lymphocytic leukemia (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 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before cycle 1 day 1.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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 not well controlled on antiretroviral therapy (ART)
  • Active HBV or hepatitis C virus (HCV) infection.
  • For Cohort C only: has any clinically significant gastrointestinal abnormalities that might alter absorption.

Trial locations and contacts

109 sites in 21 countries.

109 sites in 21 countries

United States20 sites

  • Alaska Oncology and Hematology ( Site 0037)

    Anchorage, Alaska, 99508

  • University of Michigan ( Site 0009)

    Ann Arbor, Michigan, 48109

  • University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008)

    Aurora, Colorado, 80045

  • Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010)

    Baltimore, Maryland, 21201

  • Tufts Medical Center ( Site 0024)

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital ( Site 0018)

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute-Lymphoma ( Site 0026)

    Boston, Massachusetts, 02215

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0004)

    Columbus, Ohio, 43210

  • Cancer Care Specialists of Illinois ( Site 0031)

    Decatur, Illinois, 62526

  • Henry Ford Hospital ( Site 0035)

    Detroit, Michigan, 48202

  • University of Kansas Medical Center-Division of Hematologic Malignancies and Cellular Therapeutics ( Site 0038)

    Fairway, Kansas, 66205

  • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0014)

    Fargo, North Dakota, 58102

  • Banner MD Anderson Cancer Center ( Site 0040)

    Gilbert, Arizona, 85234

  • University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030)

    Madison, Wisconsin, 53792

  • Medical College of Wisconsin ( Site 0021)

    Milwaukee, Wisconsin, 53226

  • Icahn School of Medicine at Mount Sinai ( Site 0023)

    New York, New York, 10029

  • Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036)

    Phoenix, Arizona, 85006

  • Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007)

    Saint Matthews, Kentucky, 40207

  • Avera Cancer Institute- Research ( Site 0011)

    Sioux Falls, South Dakota, 57105

  • Medical Oncology Associates, PS ( Site 0005)

    Spokane, Washington, 99208

Other trials in United States

China16 sites

  • Beijing Cancer hospital ( Site 1200)

    Beijing, Beijing Municipality, 100142

  • West China Hospital of Sichuan University-Head and Neck Oncology ( Site 1206)

    Chengdu, Sichuan, 610041

  • Jilin Province Tumor Hospital-oncology department ( Site 1220)

    Chuangchun, Jilin, 130012

  • Sun Yat-sen University Cancer Center ( Site 1201)

    Guangzhou, Guangdong, 510060

  • Zhujiang Hospital ( Site 1207)

    Guangzhou, Guangdong, 510280

  • Southern Medical University Nanfang Hospital ( Site 1202)

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University ( Site 1211)

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital ( Site 1214)

    Hangzhou, Zhejiang, 310005

  • The First Affiliated Hospital of Nanchang University ( Site 1204)

    Nanchang, Jiangxi, 330006

  • Jiangxi Provincial Cancer Hospital ( Site 1213)

    Nanchang, Jiangxi, 330029

  • Fudan University Shanghai Cancer Center ( Site 1208)

    Shanghai, Shanghai Municipality, 200032

  • The First Affiliated Hospital of Soochow University-hematology department ( Site 1218)

    Suzhou, Jiangsu, 215006

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1210)

    Wuhan, Hubei, 430023

  • Tongji Hospital Tongji Medical,Science & Technology ( Site 1221)

    Wuhan, Hubei, 430030

  • The Affiliated Hospital of Xuzhou Medical College ( Site 1223)

    Xuzhou, Jiangsu, 221000

  • Henan Cancer Hospital-hematology department ( Site 1212)

    Zhengzhou, Henan, 450003

Other trials in China

Japan9 sites

  • National Cancer Center Hospital ( Site 1103)

    Chuo-ku, Tokyo, 104-0045

  • Kyushu University Hospital ( Site 1105)

    Fukuoka, 812-8582

  • Tokai University Hospital ( Site 1100)

    Isehara, Kanagawa, 259-1193

  • Cancer Institute Hospital of JFCR ( Site 1101)

    Koto, Tokyo, 135-8550

  • National Hospital Organization Nagoya Medical Center ( Site 1108)

    Nagoya, Aichi-ken, 460-0001

  • Okayama University Hospital ( Site 1107)

    Okayama, 700-8558

  • Kindai University Hospital ( Site 1102)

    Sakai, Osaka, 590-0197

  • Hokkaido University Hospital ( Site 1104)

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital ( Site 1106)

    Sendai, Miyagi, 980-8574

Other trials in Japan

Canada7 sites

  • QEII Health Sciences Centre - Victoria General Site ( Site 0213)

    Halifax, Nova Scotia, B3H 2Y9

  • London Health Sciences Centre ( Site 0203)

    London, Ontario, N6A 5W9

  • The Moncton Hospital-Oncology ( Site 0211)

    Moncton, New Brunswick, E1C 6Z8

  • Jewish General Hospital ( Site 0202)

    Montreal, Quebec, H3T 1E2

  • Allan Blair Cancer Centre-Care Services ( Site 0208)

    Regina, Saskatchewan, S4T 7T1

  • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)

    Toronto, Ontario, M5G 2M9

  • BC Cancer Vancouver-Clinical Trials Unit ( Site 0201)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Israel7 sites

  • Emek Medical Center-Hematology Unit ( Site 0705)

    Afula, 1834111

  • Soroka Medical Center-Hematology Department ( Site 0707)

    Beersheba, 8410101

  • Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 0706)

    Haifa, 3109601

  • Carmel Hospital ( Site 0709)

    Haifa, 3436212

  • Hadassah Medical Center ( Site 0701)

    Jerusalem, 9112001

  • Galilee Medical Center ( Site 0710)

    Nahariya, 2210001

  • Sheba Medical Center-Hemato Oncology ( Site 0700)

    Ramat Gan, 5265601

Other trials in Israel

Poland6 sites

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 1010)

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • Pratia MCM Krakow ( Site 1001)

    Krakow, Lesser Poland Voivodeship, 30-727

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 1008)

    Lodz, Łódź Voivodeship, 93-513

  • Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologiczny ( Site 1006)

    Lublin, Lublin Voivodeship, 20-090

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1007)

    Olsztyn, Warmian-Masurian Voivodeship, 10-228

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 1002)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Spain5 sites

  • Hospital Universitari Vall d'Hebron ( Site 4004)

    Barcelona, Catalonia, 08035

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4003)

    L'Hospitalet Del Llobregat, Barcelona, 08908

  • MD Anderson Cancer Center ( Site 4006)

    Madrid, Madrid, Comunidad de, 28033

  • Clinica Universidad de Navarra ( Site 4005)

    Pamplona, Navarre, 31008

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( Site 4001)

    Salamanca, 37007

Other trials in Spain

Turkey (Türkiye)5 sites

  • Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 6001)

    Ankara, 06100

  • Ege Universitesi Hastanesi ( Site 6002)

    Bornova, İzmir, 35100

  • Trakya University ( Site 6005)

    Edirne, 22030

  • Ondokuz Mayıs Universitesi-Oncology department ( Site 6004)

    Samsun, 55139

  • Mega Medipol-Hematology ( Site 6009)

    Stanbul, Istanbul, 34214

Other trials in Turkey (Türkiye)

Brazil4 sites

  • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1807)

    Natal, Rio Grande do Norte, 59075-740

  • Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Site 1809)

    Rio de Janeiro, 20231-050

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1808)

    São Paulo, 01246-000

  • Hospital Paulistano-Americas Oncologia ( Site 1805)

    São Paulo, 01321-001

Other trials in Brazil

Chile4 sites

  • IC La Serena Research ( Site 1909)

    La Serena, Coquimbo Region, 1720430

  • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1907)

    Santiago, Region M. de Santiago, 7500653

  • Clínica Inmunocel ( Site 1910)

    Santiago, Region M. de Santiago, 7580206

  • Clínica Alemana de Santiago ( Site 1903)

    Santiago, Region M. de Santiago, 7650568

Other trials in Chile

Italy4 sites

  • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant ( Site 0803)

    Alessandria, 15121

  • IRCCS - AOU di Bologna-SSD: Diagnosi e terapie dei linfomi e delle sindromi linfoproliferative cron ( Site 0800)

    Bologna, Emilia-Romagna, 40138

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 0804)

    Roma, 00168

  • Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0802)

    Rozzano, Milano, 20089

Other trials in Italy

United Kingdom4 sites

  • University College London Hospital ( Site 7001)

    London, London, City of, NW1 2PG

  • The Christie NHS Foundation Trust ( Site 7007)

    Manchester, m20 4bx

  • The Churchill Hospital ( Site 7002)

    Oxford, Oxfordshire, OX3 7LE

  • The Royal Cornwall Hospital-Haematology ( Site 7006)

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Czechia3 sites

  • Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0300)

    Brno, Brno-mesto, 625 00

  • Fakultni nemocnice Ostrava-Klinika Hematoonkologie ( Site 0301)

    Ostrava, Moravian-Silesian Region, 708 52

  • Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)

    Prague, 128 08

Other trials in Czechia

Portugal3 sites

  • Unidade Local de Saude de Braga - Hospital de Braga ( Site 2001)

    Braga, 4710-243

  • Champalimaud Foundation ( Site 2002)

    Lisbon, Lisbon District, 1400-038

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2000)

    Porto, 4200-072

Other trials in Portugal

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset ( Site 5003)

    Gothenburg, Västra Götaland County, 413 45

  • Skånes Universitetssjukhus Lund ( Site 5000)

    Lund, Skåne County, 22185

  • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 5002)

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Germany2 sites

  • Universitaetsklinikum Koeln ( Site 0506)

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Ulm. ( Site 0502)

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Peru2 sites

  • Centro Medico Monte Carmelo ( Site 1702)

    Arequipa, Ariqipa, 04001

  • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 1700)

    Lima, 15038

Other trials in Peru

South Korea2 sites

  • Seoul National University Hospital ( Site 1300)

    Seoul, 03080

  • Samsung Medical Center ( Site 1301)

    Seoul, 06351

Other trials in South Korea

Estonia1 site

  • North Estonia Medical Centre Foundation ( Site 0401)

    Tallinn, Harju, 13419

Other trials in Estonia

Ireland1 site

  • St. James's Hospital ( Site 0600)

    Dublin, D08 E9P6

Other trials in Ireland

Singapore1 site

  • National Cancer Centre Singapore ( Site 1500)

    Singapore, Central Singapore, 168583

Other trials in Singapore

About this study

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 (waveLINE-006)

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
Read more

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).

As of Amendment 07, Cohort D is closed to enrollment of participants with CLL and enrollment of participants into Arm 2 (zilovertamab vedotin at Dose 2 on Days 1 \& 8 of each 3 Week Cycle (Q2/3W)).

As of Amendment 09, no additional participants with RT will be enrolled in Cohort B; however, those currently enrolled will continue with study intervention treatment (if applicable) until a protocol specified discontinuation criterion is met. Cohort E will be closed, as no participants with FL have been treated in this cohort.

Being tested
Zilovertamab vedotin, Nemtabrutinib
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zilovertamab vedotinBiological

    Also called MK-2140

    IV infusion

  • NemtabrutinibDrug

    Also called MK-1026

    Oral tablet

Study groups in NCT05458297
Study groupRoleWhat they receive
Cohort A, Relapsed or Refractory MCL with 2 Prior Lines of TherapyExperimentalParticipants will receive zilovertamab vedotin intravenous (IV) infusion at Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.
Receives: Biological: Zilovertamab vedotin
Cohort B, Relapsed or Refractory RT with 1 Prior Line of TherapyExperimentalParticipants will receive zilovertamab vedotin IV infusion at Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.
Receives: Biological: Zilovertamab vedotin
Cohort C, Relapsed or Refractory MCL with 1 Prior Line of TherapyExperimentalParticipants will receive zilovertamab vedotin IV infusion at Dose 2 every 3 weeks (Q3W) combined with nemtabrutinib oral dose daily until disease progression or discontinuation.
Receives: Biological: Zilovertamab vedotin; Drug: Nemtabrutinib
Cohort D, Relapsed or Refractory FL and CLL with 2 Prior Lines of TherapyExperimentalParticipants will receive either zilovertamab vedotin IV infusion Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.
Receives: Biological: Zilovertamab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with MCL (Cohort C), FL (Cohort D), and CLL (Cohort D) with ≥1 Adverse Event (AE)

    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 (Cohort C), FL (Cohort D), and CLL (Cohort D) who experienced an AE will be reported.

    Measured: Up to approximately 81 months

  2. Percentage of Participants with MCL (Cohort C), FL (Cohort D), and CLL (Cohort D) who Discontinue from Study Therapy Due to AE

    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 (Cohort C), FL (Cohort D), and CLL (Cohort D) who discontinued study treatment due to an AE will be reported.

    Measured: Up to approximately 81 months

  3. Percentage of Participants with MCL (Cohort C) who Experience a Dose-Limiting Toxicity (DLT)

    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 (Cohort C) as assessed by investigator will be reported.

    Measured: Up to approximately 81 months

  4. Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by Blinded Independent Central Review (BICR) in Participants with MCL (Cohort A), RT (Cohort B), and FL (Cohort D)

    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 in Participants with MCL (Cohort A), RT (Cohort B), and FL (Cohort D) will be reported.

    Measured: Up to approximately 81 months

  5. ORR per Lugano Response Criteria as Assessed by Investigator in Participants with MCL (Cohort C)

    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 in Participants with MCL (Cohort C) will be reported.

    Measured: Up to approximately 81 months

  6. ORR per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as Assessed by Investigator in Participants with CLL (Cohort D)

    ORR, defined as the percentage of participants who achieve a CR or PR per iwCLL criteria as assessed by investigator in participants with CLL (Cohort D) will be reported.

    Measured: Up to approximately 81 months

Secondary outcomes (5)

  1. Duration of Response (DOR) per Lugano Response Criteria as Assessed by BICR in Participants with MCL (Cohort A), RT (Cohort B), and FL (Cohort D)

    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, in Participants with MCL (Cohort A), RT (Cohort B), and FL (Cohort D) will be reported.

    Measured: Up to approximately 81 months

  2. DOR per Lugano Response Criteria as Assessed by Investigator in Participants with MCL (Cohort C)

    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, in participants with MCL (Cohort C) will be reported.

    Measured: Up to approximately 81 months

  3. DOR per iwCLL Criteria as Assessed by Investigator in Participants with CLL (Cohort D)

    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, in participants with CLL (Cohort D) will be reported.

    Measured: Up to approximately 81 months

  4. Percentage of Participants with ≥1 AE in Participants with MCL (Cohort A) and RT (Cohort B)

    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 (Cohort A) and RT (Cohort B) who experienced an AE will be reported.

    Measured: Up to approximately 81 months

  5. Percentage of Participants Discontinuing from Study Therapy Due to AE in Participants with MCL (Cohort A) and RT (Cohort B)

    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 (Cohort A) and RT (Cohort B) who discontinued study treatment due to an AE will be reported.

    Measured: Up to approximately 81 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2022
  2. Study start21 Jul 2022
  3. Primary completion17 May 2029 (estimated)
  4. Study completion17 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
189 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05458297
Sponsor's protocol ID
2140-006
Other IDs
MK-2140-006, jRCT2011230019, 2022-501374-19-00, U1111-1280-1849, 2021-004450-36
Status last verified
Aug 2026
First submitted
11 Jul 2022
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zilovertamab vedotin and Nemtabrutinib in people with Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, run by Merck Sharp & Dohme LLC at 109 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States, China, Japan, Canada, Israel and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with MCL (Cohort C), FL (Cohort D), and CLL (Cohort D) with ≥1 Adverse Event (AE) (time frame: Up to approximately 81 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05458297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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