Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04728893

Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

Led by Merck Sharp & Dohme LLC · Updated on 2026-05-11

490

Participants Needed

121

Research Sites

404 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).

CONDITIONS

Official Title

Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have an ECOG performance status of 0 to 2 within 7 days before starting treatment
  • Have a life expectancy of at least 3 months
  • Able to swallow and keep oral medication
  • Hepatitis B surface antigen positive participants must have received antiviral therapy for at least 4 weeks with undetectable viral load
  • Participants with past Hepatitis C infection must have undetectable viral load at screening
  • Have adequate organ function
  • Male participants must agree to avoid sperm donation and use contraception or abstain from penile-vaginal intercourse during and after treatment
  • Female participants not pregnant or breastfeeding and not of childbearing potential or using highly effective contraception or abstaining from penile-vaginal intercourse during and after treatment
  • Participants with HIV must have CD4 count >350 cells/uL, undetectable viral load, stable ART for at least 4 weeks, and compliance with ART
  • Confirmed diagnosis of CLL/SLL with at least 2 prior therapies (Part 1) or meet specific criteria for Cohorts A, B, C, or J in Part 2
  • Active disease requiring therapy for CLL/SLL
  • For SLL in Part 2, have evaluable lymph node biopsy or bone marrow aspirate for biomarker analysis
  • Confirmed diagnosis of Richter's transformation, MCL, MZL, FL, or WM with defined prior therapy and measurable disease
  • Measurable disease with at least 1 lesion measurable by CT scan
  • Provide lymph node biopsy or bone marrow aspirate for biomarker analysis as required by cohort
Not Eligible

You will not qualify if you...

  • Have active Hepatitis B or C infection
  • History of malignancy within 3 years except certain skin cancers, carcinoma in situ, or low-risk early-stage prostate cancer
  • Active central nervous system disease
  • Active infection requiring systemic therapy
  • Received systemic anti-cancer therapy within 5 half-lives or 4 weeks before starting study treatment
  • Participated in another investigational study or used an investigational device within 4 weeks before starting treatment
  • Have clinically significant gastrointestinal problems affecting absorption
  • History of severe bleeding disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 121 locations

1

Highlands Oncology Group ( Site 2728)

Springdale, Arkansas, United States, 72762

Actively Recruiting

2

University of California San Diego Moores Cancer Center ( Site 2717)

La Jolla, California, United States, 92093-0698

Actively Recruiting

3

Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site 2724)

Torrance, California, United States, 90502

Completed

4

Colorado Blood Cancer Institute ( Site 2726)

Denver, Colorado, United States, 80218

Actively Recruiting

5

The University of Louisville, James Graham Brown Cancer Center ( Site 2729)

Louisville, Kentucky, United States, 40202

Completed

6

Mayo Clinic - Rochester ( Site 2706)

Rochester, Minnesota, United States, 55905

Active, Not Recruiting

7

Astera Cancer Care ( Site 2732)

East Brunswick, New Jersey, United States, 08816

Actively Recruiting

8

John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704)

Hackensack, New Jersey, United States, 07601

Actively Recruiting

9

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2708)

Fargo, North Dakota, United States, 58102

Completed

10

UT Southwestern-Harold C. Simmons Cancer Center ( Site 2730)

Dallas, Texas, United States, 75390

Actively Recruiting

11

Medical Oncology Associates (Summit Cancer Centers) ( Site 2710)

Spokane, Washington, United States, 99208

Actively Recruiting

12

Hospital Aleman ( Site 0102)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1118AAT

Actively Recruiting

13

Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0103)

Buenos Aires, Buenos Aires F.D., Argentina, C1431FWO

Actively Recruiting

14

Fundacion Estudios Clinicos ( Site 0112)

Rosario, Santa Fe Province, Argentina, S2000DEJ

Actively Recruiting

15

FUNDALEU ( Site 0104)

Caba, Argentina, C1114AAN

Actively Recruiting

16

Hospital Privado Universitario de Córdoba ( Site 0107)

Córdoba, Argentina, X5016KEH

Actively Recruiting

17

Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0110)

Mendoza, Argentina, M5500AYB

Completed

18

Nepean Hospital-Nepean Cancer Care Centre ( Site 0204)

Sydney, New South Wales, Australia, 2747

Completed

19

Box Hill Hospital ( Site 0203)

Box Hill, Victoria, Australia, 3128

Actively Recruiting

20

Sir Charles Gairdner Hospital ( Site 0200)

Nedlands, Western Australia, Australia, 6009

Actively Recruiting

21

Hospital das Clinicas FMUSP-Pesquisa Clínica Hematologia ( Site 0303)

São Paulo, São Paulo, Brazil, 05403-000

Actively Recruiting

22

Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0300)

Rio de Janeiro, Brazil, 20231-050

Actively Recruiting

23

BP - A Beneficencia Portuguesa de São Paulo ( Site 0302)

São Paulo, Brazil, 01321-001

Completed

24

Hospital Paulistano - Amil Clinical Research ( Site 0311)

São Paulo, Brazil, 01321-001

Actively Recruiting

25

Arthur J.E. Child Comprehensive Cancer Centre ( Site 0401)

Calgary, Alberta, Canada, T2N 5G2

Actively Recruiting

26

The Ottawa Hospital ( Site 0404)

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

27

Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0406)

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

28

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0403)

Montreal, Quebec, Canada, H1T 2M4

Actively Recruiting

29

Jewish General Hospital ( Site 0400)

Montreal, Quebec, Canada, H3T 1E2

Actively Recruiting

30

Anhui Provincial Hospital ( Site 2808)

Hefei, Anhui, China, 230071

Actively Recruiting

31

Peking University Third Hospital-Hematology ( Site 2827)

Beijing, Beijing Municipality, China, 100191

Actively Recruiting

32

The Second Affiliated Hospital of Chongqing Medical University ( Site 2825)

Chongqing, Chongqing Municipality, China, 400072

Completed

33

Sun Yat-sen University Cancer Center-Internal Medicine ( Site 2824)

Guangzhou, Guangdong, China, 510060

Actively Recruiting

34

Liuzhou People's Hospital ( Site 2817)

Liuzhou, Guangxi, China, 545006

Actively Recruiting

35

Guangxi Medical University Cancer Hospital ( Site 2814)

Nanning, Guangxi, China, 530028

Actively Recruiting

36

Henan Cancer Hospital-hematology department ( Site 2802)

Zhengzhou, Henan, China, 450008

Actively Recruiting

37

Wuhan Union Hospital ( Site 2816)

Wuhan, Hubei, China, 430022

Actively Recruiting

38

The Second Xiangya Hospital of Central South University ( Site 2820)

Changsha, Hunan, China, 410011

Actively Recruiting

39

Hunan Cancer Hospital ( Site 2822)

Changsha, Hunan, China, 410013

Actively Recruiting

40

Jiangsu Province Hospital ( Site 2823)

Nanjing, Jiangsu, China, 210029

Actively Recruiting

41

The Affiliated Hospital of Xuzhou Medical College ( Site 2818)

Xuzhou, Jiangsu, China, 221000

Completed

42

The First Affiliated Hospital of Nanchang University ( Site 2815)

Nanchang, Jiangxi, China, 330006

Actively Recruiting

43

The First Hospital of Jilin University-Hematology ( Site 2803)

Changchun, Jilin, China, 130021

Actively Recruiting

44

Fudan University Shanghai Cancer Center ( Site 2801)

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

45

Huashan Hospital, Fudan University ( Site 2821)

Shanghai, Shanghai Municipality, China, 200040

Actively Recruiting

46

West China Hospital Sichuan University ( Site 2810)

Chengdu, Sichuan, China, 610041

Actively Recruiting

47

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Unio ( Site 2800)

Tianjin, Tianjin Municipality, China, 301617

Actively Recruiting

48

The First Affiliated Hospital, Zhejiang University ( Site 2826)

Hangzhou, Zhejiang, China, 310002

Actively Recruiting

49

Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0600)

Brno, Brno-mesto, Czechia, 625 00

Actively Recruiting

50

Fakultni nemocnice Hradec Kralove ( Site 0601)

Hradec Králové, Czechia, 500 05

Actively Recruiting

51

Aarhus University Hospital ( Site 0702)

Aarhus N, Central Jutland, Denmark, 8200

Completed

52

Aalborg Universitetshospital ( Site 0703)

Aalborg, North Denmark, Denmark, 9000

Actively Recruiting

53

Sjaellands Universitetshospital Roskilde ( Site 0701)

Roskilde, Region Sjælland, Denmark, 4000

Actively Recruiting

54

Odense University Hospital ( Site 0705)

Odense C, Region Syddanmark, Denmark, 5000

Completed

55

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0810)

Nice, Alpes-Maritimes, France, 06202

Actively Recruiting

56

Centre Hospitalier Lyon-Sud ( Site 0804)

Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495

Actively Recruiting

57

Institut Paoli-Calmettes ( Site 0803)

Marseille, Bouches-du-Rhone, France, 13009

Actively Recruiting

58

Centre Hospitalier de Versailles ( Site 0809)

Le Chesnay, Yvelines, France, 78150

Completed

59

Hopital Saint Louis ( Site 0805)

Paris, France, 75010

Actively Recruiting

60

Universitaetsklinikum Ulm. ( Site 0906)

Ulm, Baden-Wurttemberg, Germany, 89081

Actively Recruiting

61

Universitaetsklinikum Koeln ( Site 0901)

Cologne, North Rhine-Westphalia, Germany, 50937

Actively Recruiting

62

St. Marien-Krankenhaus Siegen ( Site 0914)

Siegen, North Rhine-Westphalia, Germany, 57072

Completed

63

Universitaetsklinikum Carl Gustav Carus ( Site 0902)

Dresden, Saxony, Germany, 01307

Actively Recruiting

64

Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar ( Site 1202)

Pécs, Baranya, Hungary, 7624

Actively Recruiting

65

Debreceni Egyetem Klinikai Kozpont ( Site 1201)

Debrecen, Hajdú-Bihar, Hungary, 4032

Actively Recruiting

66

Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 1206)

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400

Actively Recruiting

67

Orszagos Onkologiai Intezet ( Site 1200)

Budapest, Hungary, 1122

Actively Recruiting

68

Beaumont Hospital ( Site 2900)

Dublin, Ireland, Dublin 9

Actively Recruiting

69

University Hospital Limerick ( Site 2903)

Limerick, Ireland, V94 F858

Actively Recruiting

70

Ha Emek Medical Center ( Site 1305)

Afula, Israel, 1834111

Actively Recruiting

71

Soroka Medical Center ( Site 1307)

Beersheba, Israel, 8457108

Actively Recruiting

72

Rambam Medical Center ( Site 1301)

Haifa, Israel, 3109601

Actively Recruiting

73

Hadassah Ein Karem Jerusalem ( Site 1300)

Jerusalem, Israel, 9112001

Actively Recruiting

74

Chaim Sheba Medical Center ( Site 1302)

Ramat Gan, Israel, 5262001

Actively Recruiting

75

Kaplan Medical Center ( Site 1304)

Rehovot, Israel, 76100

Actively Recruiting

76

Sourasky Medical Center ( Site 1303)

Tel Aviv, Israel, 6423906

Actively Recruiting

77

Istituto Tumori Giovanni Paolo II ( Site 1409)

Bari, Italy, 70124

Actively Recruiting

78

A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1400)

Bologna, Italy, 40138

Actively Recruiting

79

ASST Spedali Civili di Brescia ( Site 1408)

Brescia, Italy, 25123

Actively Recruiting

80

IRCCS Ospedale San Raffaele ( Site 1402)

Milan, Italy, 20132

Actively Recruiting

81

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1403)

Naples, Italy, 80131

Actively Recruiting

82

Fondazione IRCCS Policlinico San Matteo ( Site 1407)

Pavia, Italy, 27100

Actively Recruiting

83

IRCCS - Arcispedale Santa Maria Nuova ( Site 1405)

Reggio Emilia, Italy, 42123

Actively Recruiting

84

Policlinico Umberto I ( Site 1404)

Roma, Italy, 00161

Completed

85

Pratia MCM Krakow ( Site 1601)

Krakow, Lesser Poland Voivodeship, Poland, 30-727

Actively Recruiting

86

Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site 1606)

Wroclaw, Lower Silesian Voivodeship, Poland, 50-367

Actively Recruiting

87

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1608)

Warsaw, Masovian Voivodeship, Poland, 02-781

Actively Recruiting

88

Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607)

Opole, Opole Voivodeship, Poland, 45-061

Completed

89

Szpitale Pomorskie Sp. z o.o. ( Site 1600)

Gdynia, Pomeranian Voivodeship, Poland, 81-519

Completed

90

Spitalul Clinic Colțea ( Site 1805)

Bucharest, Bucharest, Romania, 030171

Actively Recruiting

91

Ovidius Clinical Hospital ( Site 1804)

Ovidiu, Constanța County, Romania, 905900

Completed

92

Centrul de Diagnostic si Tratament Oncologic Brasov ( Site 1802)

Brasov, Romania, 500052

Actively Recruiting

93

Institutul Regional de Oncologie Iasi ( Site 1801)

Iași, Romania, 700483

Actively Recruiting

94

Severance Hospital Yonsei University Health System ( Site 2201)

Seoul, South Korea, 03722

Actively Recruiting

95

Samsung Medical Center ( Site 2200)

Seoul, South Korea, 06351

Actively Recruiting

96

Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 2000)

L'Hospitalet de Llobregat, Barcelona, Spain, 08908

Actively Recruiting

97

Hospital Universitario de Salamanca ( Site 2002)

Salamanca, Castille and León, Spain, 37007

Actively Recruiting

98

CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2005)

A Coruña, La Coruna, Spain, 15006

Actively Recruiting

99

Hospital General Universitario de Alicante ( Site 2007)

Alicante, Spain, 03010

Actively Recruiting

100

Hospital Universitari Vall d'Hebron ( Site 2001)

Barcelona, Spain, 08035

Actively Recruiting

101

Hospital Universitario 12 de Octubre ( Site 2003)

Madrid, Spain, 28041

Actively Recruiting

102

Hospital Puerta de Hierro ( Site 2009)

Madrid, Spain, 28222

Actively Recruiting

103

Inselspital Bern ( Site 2303)

Bern, Canton of Bern, Switzerland, 3010

Actively Recruiting

104

Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 2302)

Bellinzona, Canton Ticino, Switzerland, 6500

Actively Recruiting

105

Mega Medipol-Hematology ( Site 2406)

Stanbul, Istanbul, Turkey (Türkiye), 34214

Active, Not Recruiting

106

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2400)

Ankara, Turkey (Türkiye), 06590

Actively Recruiting

107

VKV Amerikan Hastanesi ( Site 2403)

Istanbul, Turkey (Türkiye), 34365

Completed

108

Sisli Florence Nightingale Hastanesi ( Site 2407)

Istanbul, Turkey (Türkiye), 34381

Actively Recruiting

109

Dokuz Eylül Üniversitesi-Hematology ( Site 2402)

Izmir, Turkey (Türkiye), 35340

Active, Not Recruiting

110

MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2509)

Cherkassy, Cherkasy Oblast, Ukraine, 18009

Active, Not Recruiting

111

Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 2510)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76008

Completed

112

Instit. of Blood Transfusion Medicine of the National Academy ( Site 2506)

Lviv, Lviv Oblast, Ukraine, 79044

Actively Recruiting

113

National Cancer Institute ( Site 2507)

Kyiv, Ukraine, 03022

Actively Recruiting

114

Bristol Haematology and Oncology Centre ( Site 2610)

Bristol, Bristol, City of, United Kingdom, BS2 8ED

Actively Recruiting

115

Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 2601)

Nottingham, England, United Kingdom, NG5 1PF

Actively Recruiting

116

GenesisCare - Windsor ( Site 2608)

Windsor, England, United Kingdom, SL4 3HD

Actively Recruiting

117

Sarah Cannon Research Institute UK ( Site 2612)

London, London, City of, United Kingdom, W1G 6AD

Actively Recruiting

118

GenesisCare - Oxford ( Site 2607)

Oxford, Oxfordshire, United Kingdom, OX4 6LB

Actively Recruiting

119

GenesisCare - Cambridge ( Site 2611)

Newmarket, Suffolk, United Kingdom, CB8 7XN

Actively Recruiting

120

The Royal Marsden NHS Foundation Trust. ( Site 2606)

Sutton, Surrey, United Kingdom, SM2 5PT

Actively Recruiting

121

The Christie NHS Foundation Trust ( Site 2602)

Manchester, United Kingdom, M20 4BX

Actively Recruiting

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Research Team

T

Toll Free Number

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003) | DecenTrialz