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

March 13, 2024 updated by: Merck Sharp & Dohme LLC

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Caba, Argentina, C1114AAN
        • Recruiting
        • FUNDALEU ( Site 0104)
        • Contact:
          • Study Coordinator
          • Phone Number: 5411 48771046
      • Cordoba, Argentina, X5016KEH
        • Recruiting
        • Hospital Privado Universitario de Córdoba ( Site 0107)
        • Contact:
          • Study Coordinator
          • Phone Number: +541569634187
      • Mendoza, Argentina, M5500AYB
        • Recruiting
        • Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0110)
        • Contact:
          • Study Coordinator
          • Phone Number: +54261-4252575
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1118AAT
        • Recruiting
        • Hospital Aleman ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: +541148277000
    • Caba
      • Buenos Aires, Caba, Argentina, C1431FWO
        • Recruiting
        • Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: +541152990247
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DEJ
        • Recruiting
        • Fundacion Estudios Clinicos ( Site 0112)
        • Contact:
          • Study Coordinator
          • Phone Number: +5493416149225
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2747
        • Recruiting
        • Nepean Hospital-Nepean Cancer Care Centre ( Site 0204)
        • Contact:
          • Study Coordinator
          • Phone Number: +61247343500
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Box Hill Hospital ( Site 0203)
        • Contact:
          • Study Coordinator
          • Phone Number: +611300342255
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Sir Charles Gairdner Hospital ( Site 0200)
        • Contact:
          • Study Coordinator
          • Phone Number: +61864573333
  • Brazil
      • Rio de Janeiro, Brazil, 20231-050
        • Recruiting
        • Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: +552132076564
      • Sao Paulo, Brazil, 01321-001
        • Recruiting
        • Hospital Paulistano - Amil Clinical Research ( Site 0311)
        • Contact:
          • Study Coordinator
          • Phone Number: +551130161340
      • Sao Paulo, Brazil, 01321-001
        • Active, not recruiting
        • BP - A Beneficencia Portuguesa de São Paulo ( Site 0302)
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 05403-000
        • Recruiting
        • Hospital das Clinicas FMUSP-Pesquisa Clínica Hematologia ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: 551145737543
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T4N 4N2
        • Recruiting
        • Tom Baker Cancer Centre ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: 4035213723
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital ( Site 0404)
        • Contact:
          • Study Coordinator
          • Phone Number: 613 737-7700
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0406)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-946-2827
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital ( Site 0400)
        • Contact:
          • Study Coordinator
          • Phone Number: 5143408222 x 24572
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0403)
        • Contact:
          • Study Coordinator
          • Phone Number: 5142523400
  • China
    • Anhui
      • Hefei, Anhui, China, 230071
        • Recruiting
        • Anhui Provincial Hospital ( Site 2808)
        • Contact:
          • Study Coordinator
          • Phone Number: 13866173932
    • Beijing
      • Beijing, Beijing, China, 100091
        • Recruiting
        • Peking University Third Hospital-Hematology ( Site 2827)
        • Contact:
          • Study Coordinator
          • Phone Number: 86 13661112910
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • 2nd Affiliated Hospital Chongqing Medical Universi-Hematology ( Site 2825)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613508331213
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center-Internal Medicine ( Site 2824)
        • Contact:
          • Study Coordinator
          • Phone Number: (+86)13719189172
    • Guangxi
      • Liuzhou, Guangxi, China, 545006
        • Recruiting
        • Guangxi Medical University - Liuzhou Renmin Hospital ( Site 2817)
        • Contact:
          • Study Coordinator
          • Phone Number: 13877299966
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Guangxi Medical University Affiliated Tumor Hospital ( Site 2814)
        • Contact:
          • Study Coordinator
          • Phone Number: 13507711671
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital-hematology department ( Site 2802)
        • Contact:
          • Study Coordinator
          • Phone Number: 0371-65588007
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Union Hospital ( Site 2816)
        • Contact:
          • Study Coordinator
          • Phone Number: +8618627091655
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University ( Site 2820)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613975806137
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital ( Site 2823)
        • Contact:
          • Study Coordinator
          • Phone Number: 13813810650
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical College ( Site 2818)
        • Contact:
          • Study Coordinator
          • Phone Number: 18168777317
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University ( Site 2815)
        • Contact:
          • Study Coordinator
          • Phone Number: 13970038386
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University-Hematology ( Site 2803)
        • Contact:
          • Study Coordinator
          • Phone Number: 0431-88786014
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center ( Site 2801)
        • Contact:
          • Study Coordinator
          • Phone Number: 18017312613
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University ( Site 2821)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613621778391
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • Recruiting
        • West China Hospital Sichuan University ( Site 2810)
        • Contact:
          • Study Coordinator
          • Phone Number: 18980601247
    • Tianjin
      • Tianjin, Tianjin, China, 301617
        • Recruiting
        • Institute of hematology&blood disease hospital-Lymphoma ( Site 2800)
        • Contact:
          • Study Coordinator
          • Phone Number: +8615900265415
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310002
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University ( Site 2826)
        • Contact:
          • Study Coordinator
          • Phone Number: 057187236114
  • Czechia
      • Hradec Kralove, Czechia, 50005
        • Recruiting
        • Fakultni nemocnice Hradec Kralove ( Site 0601)
        • Contact:
          • Study Coordinator
          • Phone Number: +420495832159
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 62500
        • Recruiting
        • Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0600)
        • Contact:
          • Study Coordinator
          • Phone Number: +420532233642
  • Denmark
    • Midtjylland
      • Aarhus N, Midtjylland, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital ( Site 0702)
        • Contact:
          • Study Coordinator
          • Phone Number: 004578450000
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Recruiting
        • Aalborg Universitetshospital ( Site 0703)
        • Contact:
          • Study Coordinator
          • Phone Number: 004597660000
    • Sjaelland
      • Roskilde, Sjaelland, Denmark, 4000
        • Recruiting
        • Sjaellands Universitetshospital Roskilde ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 46 32 32 00
    • Syddanmark
      • Odense C, Syddanmark, Denmark, 5000
        • Completed
        • Odense University Hospital ( Site 0705)
  • France
      • Paris, France, 75010
        • Recruiting
        • Hopital Saint Louis ( Site 0805)
        • Contact:
          • Study Coordinator
          • Phone Number: 33142499236
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Recruiting
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0810)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 4 92 03 57 85
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13009
        • Recruiting
        • Institut Paoli-Calmettes ( Site 0803)
        • Contact:
          • Study Coordinator
          • Phone Number: +33491223537
    • Rhone-Alpes
      • Pierre Benite, Rhone-Alpes, France, 69495
        • Recruiting
        • Centre Hospitalier Lyon-Sud ( Site 0804)
        • Contact:
          • Study Coordinator
          • Phone Number: +33478864348
    • Yvelines
      • Le Chesnay, Yvelines, France, 78150
        • Recruiting
        • Centre Hospitalier de Versailles ( Site 0809)
        • Contact:
          • Study Coordinator
          • Phone Number: +33139638511
  • Germany
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm ( Site 0906)
        • Contact:
          • Study Coordinator
          • Phone Number: + 49 731 500 45901
    • Nordrhein-Westfalen
      • Koeln, Nordrhein-Westfalen, Germany, 50937
        • Recruiting
        • Universitaetsklinikum Koeln ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: +4922147897046
      • Siegen, Nordrhein-Westfalen, Germany, 57072
        • Completed
        • St. Marien-Krankenhaus Siegen ( Site 0914)
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: 0049 351 458 5692
  • Hungary
      • Budapest, Hungary, 1122
        • Recruiting
        • Orszagos Onkologiai Intezet ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: +3612248600
    • Baranya
      • Pecs, Baranya, Hungary, 7624
        • Recruiting
        • Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: +3672536000
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: +3652255
    • Szabolcs-Szatmar-Bereg
      • Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
        • Recruiting
        • Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 1206)
        • Contact:
          • Study Coordinator
          • Phone Number: +3642599700
  • Ireland
      • Dublin, Ireland, Dublin 9
        • Recruiting
        • Beaumont Hospital ( Site 2900)
        • Contact:
          • Study Coordinator
          • Phone Number: +35318092010
      • Limerick, Ireland, V94 F858
        • Recruiting
        • University Hospital Limerick ( Site 2903)
        • Contact:
          • Study Coordinator
          • Phone Number: +35361588320
  • Israel
      • Afula, Israel, 1834111
        • Recruiting
        • Ha Emek Medical Center ( Site 1305)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-46494052
      • Beer-Sheva, Israel, 8410101
        • Recruiting
        • Soroka Medical Center ( Site 1307)
        • Contact:
          • Study Coordinator
          • Phone Number: +972544203424
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Medical Center ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: +97247772547
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Ein Karem Jerusalem ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: +97226778180
      • Ramat Gan, Israel, 5262001
        • Recruiting
        • Chaim Sheba Medical Center ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +972526669155
      • Rehovot, Israel, 7610001
        • Recruiting
        • Kaplan Medical Center ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: +97289441726
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Sourasky Medical Center ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: +97236973782
  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • Istituto Tumori Giovanni Paolo II ( Site 1409)
        • Contact:
          • Study Coordinator
          • Phone Number: +390805555905
      • Bologna, Italy, 40138
        • Recruiting
        • A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: +390516363680
      • Brescia, Italy, 25123
        • Recruiting
        • ASST Spedali Civili di Brescia ( Site 1408)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0303996416
      • Milano, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390226434797
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1403)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0815903 382
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo ( Site 1407)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0382503084
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • IRCCS - Arcispedale Santa Maria Nuova ( Site 1405)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0522295654
      • Roma, Italy, 00161
        • Recruiting
        • Policlinico Umberto I ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: +390649974752
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System ( Site 2201)
        • Contact:
          • Study Coordinator
          • Phone Number: +82222281972
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center ( Site 2200)
        • Contact:
          • Study Coordinator
          • Phone Number: +82234106548
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 50-367
        • Recruiting
        • Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site
        • Contact:
          • Study Coordinator
          • Phone Number: +48717842576
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-727
        • Recruiting
        • Pratia MCM Krakow ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: 48 12 2954135
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site
        • Contact:
          • Study Coordinator
          • Phone Number: 48225462366
    • Opolskie
      • Opole, Opolskie, Poland, 45-061
        • Completed
        • Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607)
    • Pomorskie
      • Gdynia, Pomorskie, Poland, 81-519
        • Recruiting
        • Szpitale Pomorskie Sp. z o.o. ( Site 1600)
        • Contact:
          • Study Coordinator
          • Phone Number: 48587260102
  • Romania
      • Brasov, Romania, 500052
        • Recruiting
        • Centrul de Diagnostic si Tratament Oncologic Brasov ( Site 1802)
        • Contact:
          • Study Coordinator
          • Phone Number: 0729075567
      • Iasi, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie Iasi ( Site 1801)
        • Contact:
          • Study Coordinator
          • Phone Number: 40374278811
    • Bucuresti
      • București, Bucuresti, Romania, 030171
        • Recruiting
        • Spitalul Clinic Colțea ( Site 1805)
        • Contact:
          • Study Coordinator
          • Phone Number: 40 744150652
    • Constanta
      • Ovidiu, Constanta, Romania, 905900
        • Recruiting
        • Ovidius Clinical Hospital ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: 40241503485
  • Spain
      • Alicante, Spain, 03010
        • Recruiting
        • Hospital General Universitario de Alicante ( Site 2007)
        • Contact:
          • Study Coordinator
          • Phone Number: +34611194484
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: +34934893806
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre ( Site 2003)
        • Contact:
          • Study Coordinator
          • Phone Number: +34917792809
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 923 29 11 00 Ext. 55974
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932607750
    • La Coruna
      • A Coruña, La Coruna, Spain, 15006
        • Recruiting
        • CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2005)
        • Contact:
          • Study Coordinator
          • Phone Number: 34981178000
  • Switzerland
    • Berne
      • Bern, Berne, Switzerland, 3010
        • Recruiting
        • Inselspital Bern ( Site 2303)
        • Contact:
          • Study Coordinator
          • Phone Number: +41316329023
    • Ticino
      • Bellinzona, Ticino, Switzerland, 6500
        • Recruiting
        • Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: +41918118540
  • Turkey
      • Ankara, Turkey, 06590
        • Recruiting
        • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2400)
        • Contact:
          • Study Coordinator
          • Phone Number: +903125957099
      • Istanbul, Turkey, 34381
        • Recruiting
        • Sisli Florence Nightingale Hastanesi ( Site 2407)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 542 502 50 75
      • Istanbul, Turkey, 34365
        • Completed
        • VKV Amerikan Hastanesi ( Site 2403)
      • Izmir, Turkey, 35340
        • Recruiting
        • Dokuz Eylül Üniversitesi-Hematology ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +905425151780
    • Istanbul
      • Stanbul, Istanbul, Turkey, 34214
        • Recruiting
        • Mega Medipol-Hematology ( Site 2406)
        • Contact:
          • Study Coordinator
          • Phone Number: 905437870708
  • Ukraine
      • Kyiv, Ukraine, 04112
        • Recruiting
        • Kyiv City Clinical Hospital 9 ( Site 2502)
        • Contact:
          • Study Coordinator
          • Phone Number: +380509105840
      • Kyiv, Ukraine, 03022
        • Recruiting
        • National Cancer Institute ( Site 2507)
        • Contact:
          • Study Coordinator
          • Phone Number: +380672091427
    • Cherkaska Oblast
      • Cherkassy, Cherkaska Oblast, Ukraine, 18009
        • Recruiting
        • MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( S
        • Contact:
          • Study Coordinator
          • Phone Number: +380634253209
    • Lvivska Oblast
      • Lviv, Lvivska Oblast, Ukraine, 79044
        • Recruiting
        • Instit. of Blood Transfusion Medicine of the National Academy ( Site 2506)
        • Contact:
          • Study Coordinator
          • Phone Number: +380322352276
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust ( Site 2602)
        • Contact:
          • Study Coordinator
          • Phone Number: 01619561217
    • Bristol, City Of
      • Bristol, Bristol, City Of, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Haematology and Oncology Centre ( Site 2610)
        • Contact:
          • Study Coordinator
          • Phone Number: +441173421121
    • England
      • Nottingham, England, United Kingdom, NG5 1PF
        • Recruiting
        • Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: +441159691169
      • Windsor, England, United Kingdom, SL4 3HD
        • Recruiting
        • GenesisCare - Windsor ( Site 2608)
        • Contact:
          • Study Coordinator
          • Phone Number: +447989474250
    • London, City Of
      • London, London, City Of, United Kingdom, w1g 6ad
        • Recruiting
        • Sarah Cannon Research Institute UK ( Site 2612)
        • Contact:
          • Study Coordinator
          • Phone Number: +44 (0) 207 725 6822
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX4 6LB
        • Recruiting
        • GenesisCare - Oxford ( Site 2607)
        • Contact:
          • Study Coordinator
          • Phone Number: +447989474250
    • Suffolk
      • Newmarket, Suffolk, United Kingdom, CB8 7XN
        • Recruiting
        • GenesisCare - Cambridge ( Site 2611)
        • Contact:
          • Study Coordinator
          • Phone Number: 01223 607910
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • The Royal Marsden NHS Foundation Trust. ( Site 2606)
        • Contact:
          • Study Coordinator
          • Phone Number: 02089156773
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group ( Site 2728)
        • Contact:
          • Study Coordinator
          • Phone Number: 479-872-8130
    • California
      • La Jolla, California, United States, 92093-0698
        • Recruiting
        • University of California San Diego Moores Cancer Center ( Site 2717)
        • Contact:
          • Study Coordinator
          • Phone Number: 858-534-5201
      • Torrance, California, United States, 90502
        • Recruiting
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site
        • Contact:
          • Study Coordinator
          • Phone Number: 424-201-3000
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute ( Site 2726)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-754-4800
    • Kentucky
      • Louisville, Kentucky, United States, 40245
        • Recruiting
        • The University of Louisville, James Graham Brown Cancer Center ( Site 2729)
        • Contact:
          • Study Coordinator
          • Phone Number: 502-562-4543
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic - Rochester ( Site 2706)
        • Contact:
          • Study Coordinator
          • Phone Number: 507-284-2511
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704)
        • Contact:
          • Study Coordinator
          • Phone Number: 551-996-3003
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Recruiting
        • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2708)
        • Contact:
          • Study Coordinator
          • Phone Number: 701-234-7592
    • Washington
      • Spokane, Washington, United States, 99208
        • Recruiting
        • Medical Oncology Associates (Summit Cancer Centers) ( Site 2710)
        • Contact:
          • Study Coordinator
          • Phone Number: 509-462-2273

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days prior to allocation
  • 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 30 days after the last dose of study intervention
  • Participants with 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)

  • Has a confirmed diagnosis of 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
    • Has active disease for CLL/SLL clearly documented to initiate therapy
    • 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 response to previous treatment of one of the following:

    • Participants with Richter's transformation who are relapsed or refractory following at least 1 line of prior therapy (Cohort D)
    • Participants with pathologically confirmed 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 MZL (including splenic, nodal, and extra nodal MZL) who are relapsed or refractory to chemoimmunotherapy and a covalent irreversible BTKi (Cohort F)
    • Participants with FL who are relapsed or refractory to chemoimmunotherapy, immunomodulatory agents (i.e. lenalidomide plus rituximab) (Cohort G)
  • Have measurable disease defined as at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral 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 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 active HBV/HCV infection (Part 1 and Part 2)
  • 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 (eg, 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 4 weeks prior to allocation
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nemtabrutinib
Participants receive nemtabrutinib orally once daily (QD) until progressive disease (PD) or discontinuation.
Drug: Nemtabrutinib
Nemtabrutinib tablets administered PO QD.
Other Names:
  • MK-1026
  • ARQ 531

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Number of participants experiencing dose-limiting toxicities (DLTs)
Time Frame: Up to ~56 days (Cycles 1-2, cycle = 28 days)
DLTs will be defined as toxicities observed during the first 2 cycles (8 weeks) of Part 1 and include: Grade ≥3 nonhematologic toxicity (except Grade 3 nausea, vomiting, diarrhea, rash, fatigue, and uncontrolled hypertension which will not be considered a DLT unless lasting ≥72 hours despite optimal supportive care); Grade 4 hematologic toxicity lasting >7 days (except Grade 3 lymphocytosis, Grade 4 platelet count decreased of any duration, or Grade 3 platelet count decreased if associated with bleeding); any Grade 3 or Grade 4 nonhematologic laboratory abnormality if values result in drug-induced liver injury, or medical intervention is required, or the abnormality leads to hospitalization, or the abnormality persists for >1 week (with exceptions); missing >25% of nemtabrutinib doses as a result of drug-related adverse events (AEs) during the first 2 cycles (8 weeks); Grade 5 toxicity.
Up to ~56 days (Cycles 1-2, cycle = 28 days)
Part 1: Number of participants experiencing adverse events (AEs)
Time Frame: Up to ~34 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported for Part 1.
Up to ~34 months
Part 1: Number of participants discontinuing study treatment due to AEs
Time Frame: Up to ~34 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to an AE will be reported for Part 1.
Up to ~34 months
Part 2: Objective Response Rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by independent central review (ICR)
Time Frame: Up to ~78 months
ORR per iwCLL 2018 criteria is defined as the percentage of participants achieving a complete response (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR), or partial response (PR). CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10^9/L or ≥50% increase from screening, hemoglobin >11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow.
Up to ~78 months
Part 2: ORR per Lugano criteria 2014 as assessed by ICR
Time Frame: Up to ~78 months
ORR per Lugano criteria 2014 is defined as the percentage of participants achieving a CR or PR. CR defined as EITHER CR by imaging (computed tomography [CT]): all lymph nodes normal (none ≥15 mm) and normal liver and spleen OR complete metabolic response (CMR): score of 1, 2 or 3 on the 5-point scale assessing fluorodeoxyglucose (FDG) metabolic activity in lymphomatous lesions (ranging from 1=no uptake above background to 5=uptake markedly higher than liver) AND bone marrow (BM) normal by morphology. PR defined as EITHER PR by imaging (CT) with ≥50% decrease in the sum of the product of diameters [SPD] of target lesions, no worsening of nontarget lesions, no new lesions and ≥50% spleen abnormal portion OR Partial Metabolic Response (PMR) with score of 4 or 5 on the FDG 5-point scale (with no new lesions) and decreased overall uptake AND residual BM abnormalities; OR CR by imaging with residual BM abnormalities; OR PR by imaging without residual BM abnormalities.
Up to ~78 months
Part 2: ORR per International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria 2014 as assessed by ICR
Time Frame: Up to ~78 months
ORR per IWWM criteria 2014 is defined as the percentage of participants achieving a CR, very good partial response (VGPR), or PR. CR is defined as all lymph nodes are normal in size (none ≥15 mm), liver and spleen normal in size, serum immunoglobulin M (IgM) values in the normal range, disappearance of monoclonal protein by immunofixation (confirmation needed with a second immunofixation at any subsequent timepoint), and no histological evidence of BM involvement. VGPR is defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in the abnormal portion of the spleen (if previously abnormal), and ≥90% decrease from baseline in serum IgM, or serum IgM values in normal range. PR is defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in serum IgM, and ≥50% decrease from baseline in the abnormal portion of the spleen (if previously abnormal).
Up to ~78 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Area Under the Curve (AUC) of Nemtabrutinib
Time Frame: At designated time points (up to ~57 days)
Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib AUC (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose [up to ~57 days]). Each cycle is 28 days.
At designated time points (up to ~57 days)
Part 1: Minimum Concentration (Cmin) of Nemtabrutinib
Time Frame: At designated time points (up to ~57 days)
Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib Cmin (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose [up to ~57 days]). Each cycle is 28 days.
At designated time points (up to ~57 days)
Part 1: Maximum Concentration (Cmax) of Nemtabrutinib
Time Frame: At designated time points (up to ~57 days)
Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib Cmax (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose [up to ~57 days]). Each cycle is 28 days.
At designated time points (up to ~57 days)
Part 1: ORR per iwCLL criteria 2018 as assessed by ICR
Time Frame: Up to ~34 months
ORR per iwCLL 2018 criteria is defined as the percentage of participants achieving a CR, CRi, nPR, or PR. CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10^9/L or ≥50% increase from screening, hemoglobin >11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow.
Up to ~34 months
Part 1: Duration of Response (DOR) per iwCLL criteria 2018 as assessed by ICR
Time Frame: Up to ~34 months
For participants with CR, CRi, nPR, or PR per iwCLL 2018 criteria, DOR is defined as the time from the first documented evidence of objective response until PD or death due to any cause, whichever occurs first. CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10^9/L or ≥50% increase from screening, hemoglobin >11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow.
Up to ~34 months
Part 2: Number of participants experiencing AEs
Time Frame: Up to ~78 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported for Part 2.
Up to ~78 months
Part 2: Number of participants discontinuing study treatment due to AEs
Time Frame: Up to ~78 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to an AE will be reported for Part 2.
Up to ~78 months
Part 2: AUC of Nemtabrutinib
Time Frame: At designated time points (up to ~57 days)
Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib AUC (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose [up to ~57 days]). Each cycle is 28 days.
At designated time points (up to ~57 days)
Part 2: Cmin of Nemtabrutinib
Time Frame: At designated time points (up to ~57 days)
Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib Cmin (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose [up to ~57 days]). Each cycle is 28 days.
At designated time points (up to ~57 days)
Part 2: Cmax of Nemtabrutinib
Time Frame: At designated time points (up to ~57 days)
Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib Cmax (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose [up to ~57 days]). Each cycle is 28 days.
At designated time points (up to ~57 days)
Part 2: DOR per iwCLL criteria 2018 as assessed by ICR
Time Frame: Up to ~78 months
For participants with CR, CRi, nPR, or PR per iwCLL 2018 criteria, DOR is defined as the time from the first documented evidence of objective response until disease progression or death due to any cause, whichever occurs first. CR is defined as meeting the following criteria: no lymph nodes >1.5 cm, spleen size <13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10^9/L or ≥50% increase from screening, hemoglobin >11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow.
Up to ~78 months
Part 2: DOR per Lugano criteria 2014 as assessed by ICR
Time Frame: Up to ~78 months
For participants with CR or PR per Lugano criteria 2014, DOR is defined as the time from the first documented evidence of objective response until PD or death due to any cause, whichever occurs first. CR defined as EITHER CR by imaging (CT): all lymph nodes normal (none ≥15 mm) and normal liver and spleen OR CMR: score of 1, 2 or 3 on the 5-point scale assessing FDG metabolic activity in lymphomatous lesions (ranging from 1=no uptake above background to 5=uptake markedly higher than liver and/or new lesions) AND BM normal by morphology. PR defined as EITHER PR by imaging (CT) with ≥50% decrease in the SPD of target lesions, no worsening of nontarget lesions, no new lesions and ≥50% spleen abnormal portion OR PMR with score of 4 or 5 on the FDG 5-point scale (with no new lesions) and decreased overall uptake AND residual BM abnormalities; OR CR by imaging with residual BM abnormalities; OR PR by imaging without residual BM abnormalities.
Up to ~78 months
Part 2: DOR per IWWM criteria 2014 as assessed by ICR
Time Frame: Up to ~78 months
For participants with CR, VGPR, or PR per IWWM criteria 2014, DOR defined as the time from first documented evidence of objective response until PD or death due to any cause, whichever occurs first. CR defined as all lymph nodes normal in size (none ≥15 mm), liver and spleen normal in size, serum IgM values in normal range, disappearance of monoclonal protein by immunofixation (confirmation needed with second immunofixation at any subsequent timepoint), and no histological evidence of BM involvement. VGPR defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in abnormal portion of the spleen (if previously abnormal), and ≥90% decrease from baseline in serum IgM, or serum IgM values in normal range. PR is defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in serum IgM, and ≥50% decrease from baseline in abnormal portion of the spleen (if previously abnormal).
Up to ~78 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2021

Primary Completion (Estimated)

March 19, 2027

Study Completion (Estimated)

March 19, 2027

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1026-003
  • MK-1026-003 (Other Identifier: Merck)
  • 2020-002324-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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