Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)
Start Date
4/5/2021
Completion Date
1/4/2029
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).
Detailed Description
This study will be performed in 2 parts: Dose Escalation and Confirmation (Part 1) and Cohort Expansion (Part 2). Following determination of the recommended phase 2 dose (RP2D) in Part 1, the study plans to proceed with Part 2 using 8 disease-specific expansion cohorts (Cohorts A to H).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Nemtabrutinib
Conditions
Locations
Highlands Oncology Group ( Site 2728)
Springdale, Arkansas 72762
United States
University of California San Diego Moores Cancer Center ( Site 2717)
La Jolla, California 92093-0698
United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site 2724)
Torrance, California 90502
United States
Colorado Blood Cancer Institute ( Site 2726)
Denver, Colorado 80218
United States
The University of Louisville, James Graham Brown Cancer Center ( Site 2729)
Louisville, Kentucky 40202
United States
Mayo Clinic - Rochester ( Site 2706)
Rochester, Minnesota 55905
United States
Astera Cancer Care ( Site 2732)
East Brunswick, New Jersey 08816
United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704)
Hackensack, New Jersey 07601
United States
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2708)
Fargo, North Dakota 58102
United States
UT Southwestern-Harold C. Simmons Cancer Center ( Site 2730)
Dallas, Texas 75390
United States
Medical Oncology Associates (Summit Cancer Centers) ( Site 2710)
Spokane, Washington 99208
United States
Hospital Aleman ( Site 0102)
Ciudad Autonoma de Buenos Aires, Buenos Aires C1118AAT
Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0103)
Buenos Aires, Buenos Aires F.D. C1431FWO
Argentina
Fundacion Estudios Clinicos ( Site 0112)
Rosario, Santa Fe Province S2000DEJ
Argentina
FUNDALEU ( Site 0104)
Caba, C1114AAN
Argentina
Hospital Privado Universitario de Córdoba ( Site 0107)
Córdoba, X5016KEH
Argentina
Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0110)
Mendoza, M5500AYB
Argentina
Nepean Hospital-Nepean Cancer Care Centre ( Site 0204)
Sydney, New South Wales 2747
Australia
Box Hill Hospital ( Site 0203)
Box Hill, Victoria 3128
Australia
Sir Charles Gairdner Hospital ( Site 0200)
Nedlands, Western Australia 6009
Australia
Hospital das Clinicas FMUSP-Pesquisa Clínica Hematologia ( Site 0303)
São Paulo, São Paulo 05403-000
Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0300)
Rio de Janeiro, 20231-050
Brazil
BP - A Beneficencia Portuguesa de São Paulo ( Site 0302)
São Paulo, 01321-001
Brazil
Hospital Paulistano - Amil Clinical Research ( Site 0311)
São Paulo, 01321-001
Brazil
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0401)
Calgary, Alberta T2N 5G2
Canada
The Ottawa Hospital ( Site 0404)
Ottawa, Ontario K1H 8L6
Canada
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0406)
Toronto, Ontario M5G 2M9
Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0403)
Montreal, Quebec H1T 2M4
Canada
Anhui Provincial Hospital ( Site 2808)
Hefei, Anhui 230071
China
Peking University Third Hospital-Hematology ( Site 2827)
Beijing, Beijing Municipality 100191
China
The Second Affiliated Hospital of Chongqing Medical University ( Site 2825)
Chongqing, Chongqing Municipality 400072
China
Sun Yat-sen University Cancer Center-Internal Medicine ( Site 2824)
Guangzhou, Guangdong 510060
China
Liuzhou People's Hospital ( Site 2817)
Liuzhou, Guangxi 545006
China
Guangxi Medical University Cancer Hospital ( Site 2814)
Nanning, Guangxi 530028
China
Henan Cancer Hospital-hematology department ( Site 2802)
Zhengzhou, Henan 450008
China
Wuhan Union Hospital ( Site 2816)
Wuhan, Hubei 430022
China
The Second Xiangya Hospital of Central South University ( Site 2820)
Changsha, Hunan 410011
China
Hunan Cancer Hospital ( Site 2822)
Changsha, Hunan 410013
China
Jiangsu Province Hospital ( Site 2823)
Nanjing, Jiangsu 210029
China
The Affiliated Hospital of Xuzhou Medical College ( Site 2818)
Xuzhou, Jiangsu 221000
China
The First Affiliated Hospital of Nanchang University ( Site 2815)
Nanchang, Jiangxi 330006
China
The First Hospital of Jilin University-Hematology ( Site 2803)
Changchun, Jilin 130021
China
Fudan University Shanghai Cancer Center ( Site 2801)
Shanghai, Shanghai Municipality 200032
China
Huashan Hospital, Fudan University ( Site 2821)
Shanghai, Shanghai Municipality 200040
China
West China Hospital Sichuan University ( Site 2810)
Chengdu, Sichuan 610041
China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Unio ( Site 2800)
Tianjin, Tianjin Municipality 301617
China
The First Affiliated Hospital, Zhejiang University ( Site 2826)
Hangzhou, Zhejiang 310002
China
Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0600)
Brno, Brno-mesto 625 00
Czechia
Fakultni nemocnice Hradec Kralove ( Site 0601)
Hradec Králové, 500 05
Czechia
Aarhus University Hospital ( Site 0702)
Aarhus N, Central Jutland 8200
Denmark
Aalborg Universitetshospital ( Site 0703)
Aalborg, North Denmark 9000
Denmark
Sjaellands Universitetshospital Roskilde ( Site 0701)
Roskilde, Region Sjælland 4000
Denmark
Odense University Hospital ( Site 0705)
Odense C, Region Syddanmark 5000
Denmark
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0810)
Nice, Alpes-Maritimes 06202
France
Centre Hospitalier Lyon-Sud ( Site 0804)
Pierre-Bénite, Auvergne-Rhône-Alpes 69495
France
Institut Paoli-Calmettes ( Site 0803)
Marseille, Bouches-du-Rhone 13009
France
Centre Hospitalier de Versailles ( Site 0809)
Le Chesnay, Yvelines 78150
France
Hopital Saint Louis ( Site 0805)
Paris, 75010
France
Universitaetsklinikum Ulm. ( Site 0906)
Ulm, Baden-Wurttemberg 89081
Germany
Universitaetsklinikum Koeln ( Site 0901)
Cologne, North Rhine-Westphalia 50937
Germany
St. Marien-Krankenhaus Siegen ( Site 0914)
Siegen, North Rhine-Westphalia 57072
Germany
Universitaetsklinikum Carl Gustav Carus ( Site 0902)
Dresden, Saxony 01307
Germany
Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar ( Site 1202)
Pécs, Baranya 7624
Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1201)
Debrecen, Hajdú-Bihar 4032
Hungary
Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 1206)
Nyíregyháza, Szabolcs-Szatmár-Bereg 4400
Hungary
Orszagos Onkologiai Intezet ( Site 1200)
Budapest, 1122
Hungary
Beaumont Hospital ( Site 2900)
Dublin, Dublin 9
Ireland
University Hospital Limerick ( Site 2903)
Limerick, V94 F858
Ireland
Ha Emek Medical Center ( Site 1305)
Afula, 1834111
Israel
Soroka Medical Center ( Site 1307)
Beersheba, 8457108
Israel
Rambam Medical Center ( Site 1301)
Haifa, 3109601
Israel
Hadassah Ein Karem Jerusalem ( Site 1300)
Jerusalem, 9112001
Israel
Chaim Sheba Medical Center ( Site 1302)
Ramat Gan, 5262001
Israel
Kaplan Medical Center ( Site 1304)
Rehovot, 76100
Israel
Sourasky Medical Center ( Site 1303)
Tel Aviv, 6423906
Israel
Istituto Tumori Giovanni Paolo II ( Site 1409)
Bari, 70124
Italy
A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1400)
Bologna, 40138
Italy
ASST Spedali Civili di Brescia ( Site 1408)
Brescia, 25123
Italy
IRCCS Ospedale San Raffaele ( Site 1402)
Milan, 20132
Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1403)
Naples, 80131
Italy
Fondazione IRCCS Policlinico San Matteo ( Site 1407)
Pavia, 27100
Italy
IRCCS - Arcispedale Santa Maria Nuova ( Site 1405)
Reggio Emilia, 42123
Italy
Policlinico Umberto I ( Site 1404)
Roma, 00161
Italy
Pratia MCM Krakow ( Site 1601)
Krakow, Lesser Poland Voivodeship 30-727
Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1606)
Wroclaw, Lower Silesian Voivodeship 50-367
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1608)
Warsaw, Masovian Voivodeship 02-781
Poland
Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607)
Opole, Opole Voivodeship 45-061
Poland
Szpitale Pomorskie Sp. z o.o. ( Site 1600)
Gdynia, Pomeranian Voivodeship 81-519
Poland
Spitalul Clinic Colțea ( Site 1805)
Bucharest, Bucharest 030171
Romania
Ovidius Clinical Hospital ( Site 1804)
Ovidiu, Constanța County 905900
Romania
Centrul de Diagnostic si Tratament Oncologic Brasov ( Site 1802)
Brasov, 500052
Romania
Institutul Regional de Oncologie Iasi ( Site 1801)
Iași, 700483
Romania
Severance Hospital Yonsei University Health System ( Site 2201)
Seoul, 03722
South Korea
Samsung Medical Center ( Site 2200)
Seoul, 06351
South Korea
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 2000)
L'Hospitalet de Llobregat, Barcelona 08908
Spain
Hospital Universitario de Salamanca ( Site 2002)
Salamanca, Castille and León 37007
Spain
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2005)
A Coruña, La Coruna 15006
Spain
Hospital General Universitario de Alicante ( Site 2007)
Alicante, 03010
Spain
Hospital Universitari Vall d'Hebron ( Site 2001)
Barcelona, 08035
Spain
Hospital Universitario 12 de Octubre ( Site 2003)
Madrid, 28041
Spain
Hospital Puerta de Hierro ( Site 2009)
Madrid, 28222
Spain
Inselspital Bern ( Site 2303)
Bern, Canton of Bern 3010
Switzerland
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 2302)
Bellinzona, Canton Ticino 6500
Switzerland
Mega Medipol-Hematology ( Site 2406)
Stanbul, Istanbul 34214
Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2400)
Ankara, 06590
Turkey (Türkiye)
VKV Amerikan Hastanesi ( Site 2403)
Istanbul, 34365
Turkey (Türkiye)
Sisli Florence Nightingale Hastanesi ( Site 2407)
Istanbul, 34381
Turkey (Türkiye)
Dokuz Eylül Üniversitesi-Hematology ( Site 2402)
Izmir, 35340
Turkey (Türkiye)
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2509)
Cherkassy, Cherkasy Oblast 18009
Ukraine
Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 2510)
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76008
Ukraine
Instit. of Blood Transfusion Medicine of the National Academy ( Site 2506)
Lviv, Lviv Oblast 79044
Ukraine
National Cancer Institute ( Site 2507)
Kyiv, 03022
Ukraine
Bristol Haematology and Oncology Centre ( Site 2610)
Bristol, Bristol, City of BS2 8ED
United Kingdom
Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 2601)
Nottingham, England NG5 1PF
United Kingdom
GenesisCare - Windsor ( Site 2608)
Windsor, England SL4 3HD
United Kingdom
Sarah Cannon Research Institute UK ( Site 2612)
London, London, City of W1G 6AD
United Kingdom
GenesisCare - Oxford ( Site 2607)
Oxford, Oxfordshire OX4 6LB
United Kingdom
GenesisCare - Cambridge ( Site 2611)
Newmarket, Suffolk CB8 7XN
United Kingdom
The Royal Marsden NHS Foundation Trust. ( Site 2606)
Sutton, Surrey SM2 5PT
United Kingdom
The Christie NHS Foundation Trust ( Site 2602)
Manchester, M20 4BX
United Kingdom