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

June 5, 2026 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 (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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

189

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 Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Site 1809)
      • São Paulo, Brazil, 01246-000
        • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1808)
      • São Paulo, Brazil, 01321-001
        • Hospital Paulistano-Americas Oncologia ( Site 1805)
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59075-740
        • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1807)
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Vancouver-Clinical Trials Unit ( Site 0201)
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • The Moncton Hospital-Oncology ( Site 0211)
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII Health Sciences Centre - Victoria General Site ( Site 0213)
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre ( Site 0203)
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital ( Site 0202)
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre-Care Services ( Site 0208)
  • Chile
    • Coquimbo Region
      • La Serena, Coquimbo Region, Chile, 1720430
        • IC La Serena Research ( Site 1909)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500653
        • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1907)
      • Santiago, Region M. de Santiago, Chile, 7580206
        • Clínica Inmunocel ( Site 1910)
      • Santiago, Region M. de Santiago, Chile, 7650568
        • Clínica Alemana de Santiago ( Site 1903)
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer hospital ( Site 1200)
    • Guangdong
      • Guangzhou, Guangdong, China, 510280
        • Zhujiang Hospital ( Site 1207)
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University Nanfang Hospital ( Site 1202)
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center ( Site 1201)
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Cancer Hospital-hematology department ( Site 1212)
    • Hubei
      • Wuhan, Hubei, China, 430023
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1210)
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Tongji Medical,Science & Technology ( Site 1221)
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University-hematology department ( Site 1218)
      • Xuzhou, Jiangsu, China, 221000
        • The Affiliated Hospital of Xuzhou Medical College ( Site 1223)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University ( Site 1204)
      • Nanchang, Jiangxi, China, 330029
        • Jiangxi Provincial Cancer Hospital ( Site 1213)
    • Jilin
      • Chuangchun, Jilin, China, 130012
        • Jilin Province Tumor Hospital-oncology department ( Site 1220)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center ( Site 1208)
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University-Head and Neck Oncology ( Site 1206)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University ( Site 1211)
      • Hangzhou, Zhejiang, China, 310005
        • Zhejiang Cancer Hospital ( Site 1214)
  • Czechia
      • Prague, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 625 00
        • Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0300)
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 708 52
        • Fakultni nemocnice Ostrava-Klinika Hematoonkologie ( Site 0301)
  • Estonia
    • Harju
      • Tallinn, Harju, Estonia, 13419
        • North Estonia Medical Centre Foundation ( Site 0401)
  • Germany
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Universitaetsklinikum Ulm. ( Site 0502)
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Universitaetsklinikum Koeln ( Site 0506)
  • Ireland
      • Dublin, Ireland, D08 E9P6
        • St. James's Hospital ( Site 0600)
  • Israel
      • Afula, Israel, 1834111
        • Emek Medical Center-Hematology Unit ( Site 0705)
      • Beersheba, Israel, 8410101
        • Soroka Medical Center-Hematology Department ( Site 0707)
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 0706)
      • Haifa, Israel, 3436212
        • Carmel Hospital ( Site 0709)
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center ( Site 0701)
      • Nahariya, Israel, 2210001
        • Galilee Medical Center ( Site 0710)
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center-Hemato Oncology ( Site 0700)
  • Italy
      • Alessandria, Italy, 15121
        • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant ( Site 0803)
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 0804)
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • IRCCS - AOU di Bologna-SSD: Diagnosi e terapie dei linfomi e delle sindromi linfoproliferative cron ( Site 0800)
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0802)
  • Japan
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital ( Site 1105)
      • Okayama, Japan, 700-8558
        • Okayama University Hospital ( Site 1107)
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center ( Site 1108)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital ( Site 1104)
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Tokai University Hospital ( Site 1100)
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital ( Site 1106)
    • Osaka
      • Sakai, Osaka, Japan, 590-0197
        • Kindai University Hospital ( Site 1102)
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital ( Site 1103)
      • Koto, Tokyo, Japan, 135-8550
        • Cancer Institute Hospital of JFCR ( Site 1101)
  • Peru
      • Lima, Peru, 15038
        • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 1700)
    • Ariqipa
      • Arequipa, Ariqipa, Peru, 04001
        • Centro Medico Monte Carmelo ( Site 1702)
  • Poland
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Pratia MCM Krakow ( Site 1001)
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-090
        • Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologiczny ( Site 1006)
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 1002)
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-228
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1007)
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-513
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 1008)
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 1010)
  • Portugal
      • Braga, Portugal, 4710-243
        • Unidade Local de Saude de Braga - Hospital de Braga ( Site 2001)
      • Porto, Portugal, 4200-072
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2000)
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1400-038
        • Champalimaud Foundation ( Site 2002)
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • National Cancer Centre Singapore ( Site 1500)
  • South Korea
      • Seoul, South Korea, 06351
        • Samsung Medical Center ( Site 1301)
      • Seoul, South Korea, 03080
        • Seoul National University Hospital ( Site 1300)
  • Spain
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( Site 4001)
    • Barcelona
      • L'Hospitalet Del Llobregat, Barcelona, Spain, 08908
        • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4003)
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Hospital Universitari Vall d'Hebron ( Site 4004)
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28033
        • MD Anderson Cancer Center ( Site 4006)
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra ( Site 4005)
  • Sweden
    • Skåne County
      • Lund, Skåne County, Sweden, 22185
        • Skånes Universitetssjukhus Lund ( Site 5000)
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 751 85
        • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 5002)
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset ( Site 5003)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 6001)
      • Edirne, Turkey (Türkiye), 22030
        • Trakya University ( Site 6005)
      • Samsun, Turkey (Türkiye), 55139
        • Ondokuz Mayıs Universitesi-Oncology department ( Site 6004)
    • Istanbul
      • Stanbul, Istanbul, Turkey (Türkiye), 34214
        • Mega Medipol-Hematology ( Site 6009)
    • İzmir
      • Bornova, İzmir, Turkey (Türkiye), 35100
        • Ege Universitesi Hastanesi ( Site 6002)
  • United Kingdom
      • Manchester, United Kingdom, m20 4bx
        • The Christie NHS Foundation Trust ( Site 7007)
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • The Royal Cornwall Hospital-Haematology ( Site 7006)
    • London, City of
      • London, London, City of, United Kingdom, NW1 2PG
        • University College London Hospital ( Site 7001)
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • The Churchill Hospital ( Site 7002)
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Oncology and Hematology ( Site 0037)
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center ( Site 0040)
      • Phoenix, Arizona, United States, 85006
        • Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008)
    • Illinois
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois ( Site 0031)
    • Kansas
      • Fairway, Kansas, United States, 66205
        • University of Kansas Medical Center-Division of Hematologic Malignancies and Cellular Therapeutics ( Site 0038)
    • Kentucky
      • Saint Matthews, Kentucky, United States, 40207
        • Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007)
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010)
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center ( Site 0024)
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital ( Site 0018)
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute-Lymphoma ( Site 0026)
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan ( Site 0009)
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital ( Site 0035)
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai ( Site 0023)
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0014)
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0004)
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute- Research ( Site 0011)
    • Washington
      • Spokane, Washington, United States, 99208
        • Medical Oncology Associates, PS ( Site 0005)
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030)
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin ( Site 0021)

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 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.

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 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.

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, Relapsed or Refractory MCL with 2 Prior Lines of Therapy
Participants will receive zilovertamab vedotin intravenous (IV) infusion at Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.
Biological: Zilovertamab vedotin
IV infusion
Other Names:
  • MK-2140
Experimental: Cohort B, Relapsed or Refractory RT with 1 Prior Line of Therapy
Participants will receive zilovertamab vedotin IV infusion at Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.
Biological: Zilovertamab vedotin
IV infusion
Other Names:
  • MK-2140
Experimental: Cohort C, Relapsed or Refractory MCL with 1 Prior Line of Therapy
Participants will receive zilovertamab vedotin IV infusion at Dose 2 every 3 weeks (Q3W) combined with nemtabrutinib oral dose daily until disease progression or discontinuation.
Biological: Zilovertamab vedotin
IV infusion
Other Names:
  • MK-2140
Drug: Nemtabrutinib
Oral tablet
Other Names:
  • MK-1026
Experimental: Cohort D, Relapsed or Refractory FL and CLL with 2 Prior Lines of Therapy
Participants will receive either zilovertamab vedotin IV infusion Dose 1 every 3 weeks (Q3W) 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 MCL (Cohort C) who Experience a Dose-Limiting Toxicity (DLT)
Time Frame: Up to approximately 81 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 (Cohort C) as assessed by investigator will be reported.
Up to approximately 81 months
ORR per Lugano Response Criteria as Assessed by Investigator in Participants with MCL (Cohort C)
Time Frame: Up to approximately 81 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 in Participants with MCL (Cohort C) will be reported.
Up to approximately 81 months
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
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.
Up to approximately 81 months
Percentage of Participants with MCL (Cohort C), FL (Cohort D), and CLL (Cohort D) who Discontinue from Study Therapy Due to AE
Time Frame: Up to approximately 81 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 (Cohort C), FL (Cohort D), and CLL (Cohort D) who discontinued study treatment due to an AE will be reported.
Up to approximately 81 months
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)
Time Frame: Up to approximately 81 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 in Participants with MCL (Cohort A), RT (Cohort B), and FL (Cohort D) will be reported.
Up to approximately 81 months
ORR per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as Assessed by Investigator in Participants with CLL (Cohort D)
Time Frame: Up to approximately 81 months
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.
Up to approximately 81 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DOR per Lugano Response Criteria as Assessed by Investigator in Participants with MCL (Cohort C)
Time Frame: Up to approximately 81 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, in participants with MCL (Cohort C) will be reported.
Up to approximately 81 months
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)
Time Frame: Up to approximately 81 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, in Participants with MCL (Cohort A), RT (Cohort B), and FL (Cohort D) will be reported.
Up to approximately 81 months
DOR per iwCLL Criteria as Assessed by Investigator in Participants with CLL (Cohort D)
Time Frame: Up to approximately 81 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, in participants with CLL (Cohort D) will be reported.
Up to approximately 81 months
Percentage of Participants with ≥1 AE in Participants with MCL (Cohort A) and RT (Cohort B)
Time Frame: Up to approximately 81 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 (Cohort A) and RT (Cohort B) who experienced an AE will be reported.
Up to approximately 81 months
Percentage of Participants Discontinuing from Study Therapy Due to AE in Participants with MCL (Cohort A) and RT (Cohort B)
Time Frame: Up to approximately 81 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 (Cohort A) and RT (Cohort B) who discontinued study treatment due to an AE will be reported.
Up to approximately 81 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)

May 17, 2029

Study Completion (Estimated)

May 17, 2029

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)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2140-006
  • MK-2140-006 (Other Identifier: MSD)
  • 2021-004450-36 (EudraCT Number)
  • jRCT2011230019 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
  • 2022-501374-19-00 (Registry Identifier: EU CT)
  • U1111-1280-1849 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/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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