Spots Global Cancer Trial Database for Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)
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Trial Identification
Brief Title: Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)
Official Title: A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies
Study ID: NCT04728893
Interventions
Study Description
Brief 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).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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
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, Caba, Argentina
Fundacion Estudios Clinicos ( Site 0112), Rosario, Santa Fe, Argentina
FUNDALEU ( Site 0104), Caba, , Argentina
Hospital Privado Universitario de Córdoba ( Site 0107), Cordoba, , 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, Sao 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), Sao Paulo, , Brazil
Hospital Paulistano - Amil Clinical Research ( Site 0311), Sao Paulo, , Brazil
Tom Baker 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, China
2nd Affiliated Hospital Chongqing Medical Universi-Hematology ( Site 2825), Chongqing, Chongqing, 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
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, China
Huashan Hospital, Fudan University ( Site 2821), Shanghai, Shanghai, China
West China Hospital Sichuan University ( Site 2810), Cheng Du, Sichuan, China
Institute of hematology&blood disease hospital-Lymphoma ( Site 2800), Tianjin, Tianjin, 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 Kralove, , Czechia
Aarhus University Hospital ( Site 0702), Aarhus N, Midtjylland, Denmark
Aalborg Universitetshospital ( Site 0703), Aalborg, Nordjylland, Denmark
Sjaellands Universitetshospital Roskilde ( Site 0701), Roskilde, Sjaelland, Denmark
Odense University Hospital ( Site 0705), Odense C, Syddanmark, Denmark
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0810), Nice, Alpes-Maritimes, France
Institut Paoli-Calmettes ( Site 0803), Marseille, Bouches-du-Rhone, France
Centre Hospitalier Lyon-Sud ( Site 0804), Pierre Benite, Rhone-Alpes, 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), Koeln, Nordrhein-Westfalen, Germany
St. Marien-Krankenhaus Siegen ( Site 0914), Siegen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Carl Gustav Carus ( Site 0902), Dresden, Sachsen, Germany
Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar ( Site 1202), Pecs, Baranya, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1201), Debrecen, Hajdu-Bihar, Hungary
Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 1206), Nyiregyhaza, Szabolcs-Szatmar-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), Beer-Sheva, , 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), Milano, , 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
Severance Hospital Yonsei University Health System ( Site 2201), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 2200), Seoul, , Korea, Republic of
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site, Wroclaw, Dolnoslaskie, Poland
Pratia MCM Krakow ( Site 1601), Krakow, Malopolskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site, Warszawa, Mazowieckie, Poland
Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607), Opole, Opolskie, Poland
Szpitale Pomorskie Sp. z o.o. ( Site 1600), Gdynia, Pomorskie, Poland
Spitalul Clinic Colțea ( Site 1805), București, Bucuresti, Romania
Ovidius Clinical Hospital ( Site 1804), Ovidiu, Constanta, Romania
Centrul de Diagnostic si Tratament Oncologic Brasov ( Site 1802), Brasov, , Romania
Institutul Regional de Oncologie Iasi ( Site 1801), Iasi, , Romania
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 2000), Hospitalet de Llobregat, Barcelona, 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 Universitario de Salamanca ( Site 2002), Salamanca, , Spain
Inselspital Bern ( Site 2303), Bern, Berne, Switzerland
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 2302), Bellinzona, Ticino, Switzerland
Mega Medipol-Hematology ( Site 2406), Stanbul, Istanbul, Turkey
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2400), Ankara, , Turkey
VKV Amerikan Hastanesi ( Site 2403), Istanbul, , Turkey
Sisli Florence Nightingale Hastanesi ( Site 2407), Istanbul, , Turkey
Dokuz Eylül Üniversitesi-Hematology ( Site 2402), Izmir, , Turkey
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( S, Cherkassy, Cherkaska Oblast, Ukraine
Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 2510), Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Instit. of Blood Transfusion Medicine of the National Academy ( Site 2506), Lviv, Lvivska 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
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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