Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)
NCT ID: NCT04728893
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
490 participants
INTERVENTIONAL
2021-04-05
2027-03-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nemtabrutinib
Participants receive nemtabrutinib orally once daily (QD) until progressive disease (PD) or discontinuation.
Nemtabrutinib
Nemtabrutinib tablets administered orally QD.
Interventions
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Nemtabrutinib
Nemtabrutinib tablets administered orally QD.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a life expectancy of at least 3 months, based on the investigator assessment
* Has the ability to swallow and retain oral medication
* 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
* Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
* Has adequate organ function
* Male participants agree to refrain from donating sperm and agree to either remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for at least the time required to eliminate the study intervention after last dose of study intervention
* Female participants assigned female sex at birth who are not pregnant or breastfeeding are eligible to participate if not a participant of childbearing potential (POCBP), or if a POCBP they either use a contraceptive method that is highly effective OR remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle during the intervention period and for at least to eliminate study intervention after the last dose of study intervention
* Participants with Human immunodeficiency virus (HIV) are eligible if they meet all of the following: the CD4 count is \>350 cells/uL at screening, the HIV viral load is below the detectable level, are on a stable ART regimen for at least 4 weeks prior to study entry, and are compliant with their ART
Part 1 and Part 2 (Cohorts A to C and J)
* Has a confirmed diagnosis of Chronic lymphocytic leukemia/ Small lymphocytic lymphoma (CLL/SLL) with
* At least 2 lines of prior therapy (Part 1 only)
* Part 2 Cohort A: CLL/SLL participants who are relapsed or refractory to prior therapy with a covalent, irreversible Bruton's tyrosine kinase inhibitor (BTKi), and a B-cell lymphoma 2 inhibitor (BCL2i). CLL participants must have received and failed, been intolerant to, or determined by their treating physician to be a poor phosphoinositide 3-kinase inhibitor (PI3Ki) candidate or ineligible for a PI3Ki per local guidelines
* Part 2 Cohort B: CLL/SLL participants who are relapsed or refractory following at least 1 line of prior therapy and are BTKi treatment naive
* Part 2 Cohort C: CLL/SLL participants with 17p deletion or tumor protein p53 (TP53) mutation who are relapsed or refractory following at least 1 line of prior therapy
* Part 2 Cohort J: CLL/SLL participants whose disease relapsed or was refractory to prior therapy with a covalent/irreversible BTKi and BCL2i. NOTE: As of Protocol Amendment 09, at least 10 CLL/SLL participants whose disease relapsed or was refractory to prior therapy with a covalent/irreversible BTKi, BCL2i and noncovalent/reversible BTKi (all three classes of therapies are required) will be enrolled into Cohort J
* Has active disease for CLL/SLL clearly documented to initiate therapy
* For SLL participants in Part 2: Has evaluable core or excisional lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate at Screening (optional for participants enrolling in Part 1)
Part 2 (Cohorts D to G)
\- Has a confirmed diagnosis of and meets the following prior therapy requirements:
* Participants with Richter's transformation who are relapsed or refractory following at least 1 line of prior therapy (Cohort D)
* Participants with pathologically confirmed Mantle-cell lymphoma (MCL), documented by either overexpression of cyclin D1 or t (11;14), who are relapsed or are refractory to chemoimmunotherapy and a covalent irreversible BTKi (Cohort E)
* Participants with Marginal zone lymphoma (MZL) (including splenic, nodal, and extra nodal MZL) who are relapsed or refractory to at least one prior line of systemic therapy including an anti-CD20-based regimen
* Participants with Follicular lymphoma (FL) who are relapsed or refractory to chemoimmunotherapy and immunomodulatory agents (such as lenalidomide based regimen) (Cohort G)
* Have measurable disease defined as at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral Computed tomography (CT) scan
* Has a lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate (Cohort D) at Screening
Part 2 (Cohort H): confirmed diagnosis of Waldenström's macroglobulinemia (WM); participants who are relapsed or refractory to standard therapies for WM including chemoimmunotherapy and a covalent irreversible BTKi
* Has active disease defined as 1 of the following: systemic symptoms, physical findings, laboratory abnormalities, coexisting disease
* Has measurable disease, satisfying any of the following: at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan (minimum measurement must be \>15 mm in the longest diameter or \>10 mm in the short axis); IgM ≥450 mg/dL; or bone marrow infiltration of 10%
* Has fresh bone marrow aspirate or a lymph node biopsy for biomarker analysis at Screening or a lymph node biopsy from an archival
Exclusion Criteria
* Has a history of malignancy ≤3 years before providing documented informed consent. Participants with basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy are not excluded. Participants with low-risk, early-stage prostate cancer (T1-T2a, Gleason score ≤6, and prostate-specific antigen \<10 ng/mL) either treated with definitive intent or untreated in active surveillance with SD are not excluded
* Has active central nervous system (CNS) disease
* Has an active infection requiring systemic therapy
* Has received prior systemic anti-cancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before C1D1
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
* Has any clinically significant gastrointestinal abnormalities that might alter absorption
* History of severe bleeding disorders
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Highlands Oncology Group ( Site 2728)
Springdale, Arkansas, United States
University of California San Diego Moores Cancer Center ( Site 2717)
La Jolla, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site 2724)
Torrance, California, United States
Colorado Blood Cancer Institute ( Site 2726)
Denver, Colorado, United States
The University of Louisville, James Graham Brown Cancer Center ( Site 2729)
Louisville, Kentucky, United States
Mayo Clinic - Rochester ( Site 2706)
Rochester, Minnesota, United States
Astera Cancer Care ( Site 2732)
East Brunswick, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704)
Hackensack, New Jersey, United States
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2708)
Fargo, North Dakota, United States
UT Southwestern-Harold C. Simmons Cancer Center ( Site 2730)
Dallas, Texas, United States
Medical Oncology Associates (Summit Cancer Centers) ( Site 2710)
Spokane, Washington, United States
Hospital Aleman ( Site 0102)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0103)
Buenos Aires, Buenos Aires F.D., Argentina
Fundacion Estudios Clinicos ( Site 0112)
Rosario, Santa Fe Province, Argentina
FUNDALEU ( Site 0104)
Caba, , Argentina
Hospital Privado Universitario de Córdoba ( Site 0107)
Córdoba, , Argentina
Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0110)
Mendoza, , Argentina
Nepean Hospital-Nepean Cancer Care Centre ( Site 0204)
Sydney, New South Wales, Australia
Box Hill Hospital ( Site 0203)
Box Hill, Victoria, Australia
Sir Charles Gairdner Hospital ( Site 0200)
Nedlands, Western Australia, Australia
Hospital das Clinicas FMUSP-Pesquisa Clínica Hematologia ( Site 0303)
São Paulo, São Paulo, Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0300)
Rio de Janeiro, , Brazil
BP - A Beneficencia Portuguesa de São Paulo ( Site 0302)
São Paulo, , Brazil
Hospital Paulistano - Amil Clinical Research ( Site 0311)
São Paulo, , Brazil
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0401)
Calgary, Alberta, Canada
The Ottawa Hospital ( Site 0404)
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0406)
Toronto, Ontario, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0403)
Montreal, Quebec, Canada
Jewish General Hospital ( Site 0400)
Montreal, Quebec, Canada
Anhui Provincial Hospital ( Site 2808)
Hefei, Anhui, China
Peking University Third Hospital-Hematology ( Site 2827)
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University ( Site 2825)
Chongqing, Chongqing Municipality, China
Sun Yat-sen University Cancer Center-Internal Medicine ( Site 2824)
Guangzhou, Guangdong, China
Guangxi Medical University - Liuzhou Renmin Hospital ( Site 2817)
Liuzhou, Guangxi, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 2814)
Nanning, Guangxi, China
Henan Cancer Hospital-hematology department ( Site 2802)
Zhengzhou, Henan, China
Wuhan Union Hospital ( Site 2816)
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University ( Site 2820)
Changsha, Hunan, China
Hunan Cancer Hospital ( Site 2822)
Changsha, Hunan, China
Jiangsu Province Hospital ( Site 2823)
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College ( Site 2818)
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University ( Site 2815)
Nanchang, Jiangxi, China
The First Hospital of Jilin University-Hematology ( Site 2803)
Changchun, Jilin, China
Fudan University Shanghai Cancer Center ( Site 2801)
Shanghai, Shanghai Municipality, China
Huashan Hospital, Fudan University ( Site 2821)
Shanghai, Shanghai Municipality, China
West China Hospital Sichuan University ( Site 2810)
Chengdu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Unio ( Site 2800)
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University ( Site 2826)
Hangzhou, Zhejiang, China
Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0600)
Brno, Brno-mesto, Czechia
Fakultni nemocnice Hradec Kralove ( Site 0601)
Hradec Králové, , Czechia
Aarhus University Hospital ( Site 0702)
Aarhus N, Central Jutland, Denmark
Aalborg Universitetshospital ( Site 0703)
Aalborg, North Denmark, Denmark
Sjaellands Universitetshospital Roskilde ( Site 0701)
Roskilde, Region Sjælland, Denmark
Odense University Hospital ( Site 0705)
Odense C, Region Syddanmark, Denmark
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0810)
Nice, Alpes-Maritimes, France
Centre Hospitalier Lyon-Sud ( Site 0804)
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Institut Paoli-Calmettes ( Site 0803)
Marseille, Bouches-du-Rhone, France
Centre Hospitalier de Versailles ( Site 0809)
Le Chesnay, Yvelines, France
Hopital Saint Louis ( Site 0805)
Paris, , France
Universitaetsklinikum Ulm. ( Site 0906)
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Koeln ( Site 0901)
Cologne, North Rhine-Westphalia, Germany
St. Marien-Krankenhaus Siegen ( Site 0914)
Siegen, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus ( Site 0902)
Dresden, Saxony, Germany
Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar ( Site 1202)
Pécs, Baranya, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1201)
Debrecen, Hajdú-Bihar, Hungary
Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 1206)
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Orszagos Onkologiai Intezet ( Site 1200)
Budapest, , Hungary
Beaumont Hospital ( Site 2900)
Dublin, , Ireland
University Hospital Limerick ( Site 2903)
Limerick, , Ireland
Ha Emek Medical Center ( Site 1305)
Afula, , Israel
Soroka Medical Center ( Site 1307)
Beersheba, , Israel
Rambam Medical Center ( Site 1301)
Haifa, , Israel
Hadassah Ein Karem Jerusalem ( Site 1300)
Jerusalem, , Israel
Chaim Sheba Medical Center ( Site 1302)
Ramat Gan, , Israel
Kaplan Medical Center ( Site 1304)
Rehovot, , Israel
Sourasky Medical Center ( Site 1303)
Tel Aviv, , Israel
Istituto Tumori Giovanni Paolo II ( Site 1409)
Bari, , Italy
A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1400)
Bologna, , Italy
ASST Spedali Civili di Brescia ( Site 1408)
Brescia, , Italy
IRCCS Ospedale San Raffaele ( Site 1402)
Milan, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1403)
Napoli, , Italy
Fondazione IRCCS Policlinico San Matteo ( Site 1407)
Pavia, , Italy
IRCCS - Arcispedale Santa Maria Nuova ( Site 1405)
Reggio Emilia, , Italy
Policlinico Umberto I ( Site 1404)
Roma, , Italy
Pratia MCM Krakow ( Site 1601)
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site 1606)
Wroclaw, Lower Silesian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1608)
Warsaw, Masovian Voivodeship, Poland
Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607)
Opole, Opole Voivodeship, Poland
Szpitale Pomorskie Sp. z o.o. ( Site 1600)
Gdynia, Pomeranian Voivodeship, Poland
Spitalul Clinic Colțea ( Site 1805)
Bucharest, București, Romania
Ovidius Clinical Hospital ( Site 1804)
Ovidiu, Constanța County, Romania
Centrul de Diagnostic si Tratament Oncologic Brasov ( Site 1802)
Brasov, , Romania
Institutul Regional de Oncologie Iasi ( Site 1801)
Iași, , Romania
Severance Hospital Yonsei University Health System ( Site 2201)
Seoul, , South Korea
Samsung Medical Center ( Site 2200)
Seoul, , South Korea
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 2000)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Salamanca ( Site 2002)
Salamanca, Castille and León, Spain
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2005)
A Coruña, La Coruna, Spain
Hospital General Universitario de Alicante ( Site 2007)
Alicante, , Spain
Hospital Universitari Vall d'Hebron ( Site 2001)
Barcelona, , Spain
Hospital Universitario 12 de Octubre ( Site 2003)
Madrid, , Spain
Hospital Puerta de Hierro ( Site 2009)
Madrid, , Spain
Inselspital Bern ( Site 2303)
Bern, Canton of Bern, Switzerland
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 2302)
Bellinzona, Canton Ticino, Switzerland
Mega Medipol-Hematology ( Site 2406)
Stanbul, Istanbul, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2400)
Ankara, , Turkey (Türkiye)
VKV Amerikan Hastanesi ( Site 2403)
Istanbul, , Turkey (Türkiye)
Sisli Florence Nightingale Hastanesi ( Site 2407)
Istanbul, , Turkey (Türkiye)
Dokuz Eylül Üniversitesi-Hematology ( Site 2402)
Izmir, , Turkey (Türkiye)
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2509)
Cherkassy, Cherkasy Oblast, Ukraine
Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 2510)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Instit. of Blood Transfusion Medicine of the National Academy ( Site 2506)
Lviv, Lviv Oblast, Ukraine
National Cancer Institute ( Site 2507)
Kyiv, , Ukraine
Kyiv City Clinical Hospital 9 ( Site 2502)
Kyiv, , Ukraine
Bristol Haematology and Oncology Centre ( Site 2610)
Bristol, Bristol, City of, United Kingdom
Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 2601)
Nottingham, England, United Kingdom
GenesisCare - Windsor ( Site 2608)
Windsor, England, United Kingdom
Sarah Cannon Research Institute UK ( Site 2612)
London, London, City of, United Kingdom
GenesisCare - Oxford ( Site 2607)
Oxford, Oxfordshire, United Kingdom
GenesisCare - Cambridge ( Site 2611)
Newmarket, Suffolk, United Kingdom
The Royal Marsden NHS Foundation Trust. ( Site 2606)
Sutton, Surrey, United Kingdom
The Christie NHS Foundation Trust ( Site 2602)
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-1026-003
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504931-42-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1290-4004
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-002324-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1026-003
Identifier Type: -
Identifier Source: org_study_id