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.
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
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Follicular Lymphoma
- What is being tested?
- Zilovertamab vedotin and Nemtabrutinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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.
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- 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Germany2 sites
Universitaetsklinikum Koeln ( Site 0506)
Cologne, North Rhine-Westphalia, 50937
Universitaetsklinikum Ulm. ( Site 0502)
Ulm, Baden-Wurttemberg, 89081
Peru2 sites
Centro Medico Monte Carmelo ( Site 1702)
Arequipa, Ariqipa, 04001
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 1700)
Lima, 15038
South Korea2 sites
Seoul National University Hospital ( Site 1300)
Seoul, 03080
Samsung Medical Center ( Site 1301)
Seoul, 06351
Estonia1 site
North Estonia Medical Centre Foundation ( Site 0401)
Tallinn, Harju, 13419
Singapore1 site
National Cancer Centre Singapore ( Site 1500)
Singapore, Central Singapore, 168583
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.
- Conditions
- Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Follicular Lymphoma, Richter Transformation Lymphoma
- 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 group | Role | What they receive |
|---|---|---|
| Cohort A, Relapsed or Refractory MCL with 2 Prior Lines of Therapy | Experimental | Participants 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 Therapy | Experimental | Participants 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 Therapy | Experimental | 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. Receives: Biological: Zilovertamab vedotin; Drug: Nemtabrutinib |
| Cohort D, Relapsed or Refractory FL and CLL with 2 Prior Lines of Therapy | Experimental | Participants 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.
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
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
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
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
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
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)
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
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
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
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
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.
- First posted14 Jul 2022
- Study start21 Jul 2022
- Primary completion17 May 2029 (estimated)
- Study completion17 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
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