RecruitingPhase 2NCT04728893

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

A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies


Sponsor

Merck Sharp & Dohme LLC

Enrollment

490 participants

Start Date

Apr 5, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests nemtabrutinib (MK-1026), an oral drug that blocks a key protein involved in B-cell blood cancers, in patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or other blood cancers that have stopped responding to prior treatments, including newer targeted therapies. **You may be eligible if:** - You have a confirmed diagnosis of CLL, SLL, or another eligible blood cancer - Your cancer has relapsed or is no longer responding to prior treatment - Your overall health and organ function are adequate - You are able to swallow oral medication - You are willing to use contraception during and after treatment **You may NOT be eligible if:** - You have hepatitis B with active replication (uncontrolled) - You are pregnant or breastfeeding - You have poor organ function or a very short life expectancy - You do not meet the specific prior treatment requirements for the cohort you are enrolling in Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNemtabrutinib

Nemtabrutinib tablets administered orally QD.


Locations(121)

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

Liuzhou People's Hospital ( Site 2817)

Liuzhou, Guangxi, China

Guangxi Medical University Cancer 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)

Naples, 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, Bucharest, 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

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

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NCT04728893


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