A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011)
6 other identifiers
interventional
1,200
29 countries
196
Brief Summary
The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2023
Longer than P75 for phase_3
196 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedStudy Start
First participant enrolled
December 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 7, 2032
April 28, 2026
April 1, 2026
8.7 years
November 13, 2023
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)
ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR), per iwCLL Criteria 2018 as assessed by BICR.
Up to ~33 months
Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by BICR
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is evaluated per iwCLL Criteria 2018 as assessed by BICR.
Up to ~104 months
Secondary Outcomes (4)
Overall Survival (OS)
Up to ~104 months
Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR
Up to ~104 months
Number of Participants Who Experience One or More Adverse Events (AEs)
Up to ~104 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Up to ~104 months
Study Arms (2)
Nemtabrutinib
EXPERIMENTALParticipants will receive nemtabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met.
Ibrutinib/Acalabrutinib
ACTIVE COMPARATORParticipants will receive investigator's choice of ibrutinib or acalabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met.
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.
- Has at least 1 marker of disease burden.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization.
- 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 deoxyribonucleic acid (DNA) viral load before randomization.
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening.
- Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.
You may not qualify if:
- Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
- Has gastrointestinal (GI) dysfunction that may affect drug absorption.
- Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
- Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.
- Has clinically significant cardiovascular disease.
- Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.
- Has history of severe bleeding disorder.
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Has received any systemic anticancer therapy for CLL/SLL.
- Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.
- Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening.
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (196)
USA Mitchell Cancer Institute ( Site 0014)
Mobile, Alabama, 36604, United States
Banner MD Anderson Cancer Center ( Site 0059)
Gilbert, Arizona, 85234, United States
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)
Phoenix, Arizona, 85006, United States
Arizona Oncology Associates - NAHOA ( Site 8007)
Prescott, Arizona, 86301, United States
Alta Bates Summit Medical Center ( Site 0004)
Berkeley, California, 94704, United States
Moores Cancer Center ( Site 0003)
La Jolla, California, 92093-0698, United States
Care Access - South Pasadena ( Site 0070)
Pasadena, California, 91105, United States
Saint Joseph Hospital ( Site 0026)
Denver, Colorado, 80218, United States
Lutheran Medical Center ( Site 0027)
Golden, Colorado, 80401, United States
Intermountain Health St. Mary's Regional Hospital ( Site 0025)
Grand Junction, Colorado, 81501, United States
Eastern CT Hematology & Oncology Associates ( Site 0033)
Norwich, Connecticut, 06360, United States
Clermont Oncology Center ( Site 0046)
Clermont, Florida, 34711, United States
Florida Cancer Specialists - South ( Site 7001)
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists - East ( Site 7002)
West Palm Beach, Florida, 33401, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0002)
Fort Wayne, Indiana, 46845, United States
University of Iowa Health Care. ( Site 0017)
Waukee, Iowa, 50263, United States
University of Iowa Health Care. ( Site 0057)
Waukee, Iowa, 50263, United States
Saint Elizabeth Healthcare ( Site 0041)
Edgewood, Kentucky, 41017, United States
Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)
Grand Rapids, Michigan, 49503, United States
Regions Hospital ( Site 0042)
Saint Louis Park, Minnesota, 55416, United States
MidAmerica Cancer Care, LLC ( Site 0043)
Kansas City, Missouri, 64132, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052)
Billings, Montana, 59102, United States
Summit Medical Group Cancer Center ( Site 0007)
Florham Park, New Jersey, 07932, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute ( Site 0023)
Buffalo, New York, 14263, United States
Carolina Oncology Specialists, PA ( Site 0054)
Charlotte, North Carolina, 28207, United States
Southeastern Medical Oncology Center ( Site 0049)
Goldsboro, North Carolina, 27534, United States
Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002)
Broomall, Pennsylvania, 19008, United States
Cancer Care Associates Of York ( Site 0005)
York, Pennsylvania, 17403, United States
Tennessee Oncology-Chattanooga ( Site 0045)
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0031)
Nashville, Tennessee, 37203, United States
Texas Oncology - Central/South Texas ( Site 8008)
Austin, Texas, 78705, United States
The Center for Cancer and Blood Disorders ( Site 0032)
Fort Worth, Texas, 76104, United States
Texas Oncology - San Antonio ( Site 8006)
San Antonio, Texas, 78217, United States
Texas Oncology - Northeast Texas ( Site 8012)
Tyler, Texas, 75702, United States
University of Virginia Cancer Center ( Site 0040)
Charlottesville, Virginia, 22903, United States
Inova Schar Cancer Institute ( Site 0015)
Fairfax, Virginia, 22031, United States
Virginia Commonwealth University (VCU) Medical Center ( Site 0030)
Richmond, Virginia, 23298, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)
Spokane, Washington, 99208, United States
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048)
Madison, Wisconsin, 53715, United States
University Hospital and UW Health Clinics ( Site 0006)
Madison, Wisconsin, 53792, United States
Royal North Shore Hospital ( Site 2806)
St Leonards, New South Wales, 2065, Australia
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)
Mechelen, Antwerpen, 2800, Belgium
UZ Leuven-Hematology ( Site 0200)
Leuven, Vlaams-Brabant, 3000, Belgium
Hospital 9 De Julho ( Site 2206)
São Paulo, São Paulo, 01409-001, Brazil
Instituto Nacional de Câncer - INCA ( Site 2201)
Rio de Janeiro, 20230-130, Brazil
Hospital Paulistano-Americas Oncologia ( Site 2202)
São Paulo, 01321-001, Brazil
BC Cancer Kelowna ( Site 0112)
Kelowna, British Columbia, V1Y 5L3, Canada
BC Cancer Victoria ( Site 0109)
Victoria, British Columbia, V8R 6V5, Canada
William Osler Health System ( Site 0103)
Brampton, Ontario, L6R 3J7, Canada
The Ottawa Hospital - General Campus ( Site 0102)
Ottawa, Ontario, K1H 8L6, Canada
McGill University Health Centre ( Site 0106)
Montreal, Quebec, H4A 3J1, Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100)
Rimouski, Quebec, G5L 5T1, Canada
FALP-UIDO ( Site 2300)
Santiago, Region M. de Santiago, 7500921, Chile
Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306)
Santiago, Region M. de Santiago, 7650568, Chile
Bradfordhill-Clinical Area ( Site 2310)
Santiago, Region M. de Santiago, 8420383, Chile
Anhui Provincial Cancer Hospital ( Site 2001)
Hefei, Anhui, 230000, China
Peking University First Hospital ( Site 2022)
Beijing, Beijing Municipality, 100034, China
Peking University Third Hospital-Hematology ( Site 2011)
Beijing, Beijing Municipality, 100191, China
Chongqing University Cancer Hospital ( Site 2041)
Chongqing, Chongqing Municipality, 400030, China
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006)
Guangzhou, Guangdong, 510515, China
Sun Yat-sen University Cancer Center ( Site 2028)
Guangzhou, Guangdong, 510700, China
Liuzhou People's Hospital ( Site 2029)
Liuchow, Guangxi, 545006, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 2004)
Nanning, Guangxi, 530200, China
The Affiliated Hospital of Guizhou Medical University ( Site 2024)
Guiyang, Guizhou, 550004, China
Hainan General Hospital ( Site 2018)
Haikou, Hainan, 570311, China
Wuhan Union Hospital ( Site 2015)
Wuhan, Hebei, 4730056, China
Henan Cancer Hospital-hematology department ( Site 2025)
Zhengzhou, Henan, 450008, China
Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016)
Wuhan, Hubei, 430000, China
Hunan Cancer Hospital ( Site 2020)
Changsha, Hunan, 410006, China
The Second Xiangya Hospital of Central South University ( Site 2010)
Changsha, Hunan, 410011, China
Jiangsu Province Hospital ( Site 2000)
Nanjing, Jiangsu, 210029, China
The First Affliated Hospital of Suzhou University ( Site 2027)
Suzhou, Jiangsu, 215000, China
The Affiliated Hospital of Xuzhou Medical College ( Site 2013)
Xuzhou, Jiangsu, 221006, China
The First Affiliated Hospital of Nanchang University ( Site 2023)
Nanchang, Jiangxi, 330006, China
Jiangxi Provincial Cancer Hospital ( Site 2009)
Nanchang, Jiangxi, 330029, China
The First Hospital of Jilin University-Hematology ( Site 2030)
Changchun, Jilin, 130021, China
Shaanxi provincial people's hospital ( Site 2012)
Xi'an, Shaanxi, 710068, China
Shandong Cancer Hospital ( Site 2003)
Jinan, Shandong, 250117, China
Shanxi Cancer Hospital ( Site 2033)
Taiyuan, Shanxi, 030000, China
West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026)
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019)
Tianjin, Tianjin Municipality, 300060, China
Institute of hematology&blood disease hospital-Lymphoma ( Site 2005)
Tianjin, Tianjin Municipality, 301617, China
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014)
Ürümqi, Xinjiang, 830000, China
The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002)
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer Hospital ( Site 2017)
Hangzhou, Zhejiang, 310022, China
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405)
Valledupar, Cesar Department, 200001, Colombia
IMAT S.A.S ( Site 2401)
Montería, Departamento de Córdoba, 230002, Colombia
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402)
Cali, Valle del Cauca Department, 760032, Colombia
Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301)
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc ( Site 0303)
Olomouc, 779 00, Czechia
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)
Prague, 128 08, Czechia
Aalborg Universitetshospital, Syd ( Site 0403)
Aalborg, North Denmark, 9000, Denmark
Roskilde Sygehus-Department of Hematology ( Site 0402)
Roskilde, Region Sjælland, 4000, Denmark
Odense Universitetshospital-Department of Hematology ( Site 0401)
Odense C, Region Syddanmark, 5000, Denmark
Universitaetsklinikum Ulm. ( Site 0601)
Ulm, Baden-Wurttemberg, 89081, Germany
VK&K Studien GbR ( Site 0607)
Landshut, Bavaria, 84036, Germany
Kliniken Maria Hilf ( Site 0603)
Mönchengladbach, North Rhine-Westphalia, 41063, Germany
InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606)
Koblenz, Rhineland-Palatinate, 56068, Germany
Universitätsklinikum Halle ( Site 0604)
Halle, Saxony-Anhalt, 06120, Germany
Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600)
Berlin, 10707, Germany
Evangelismos General Hospital of Athens ( Site 0700)
Athens, Attica, 106 76, Greece
General Hospital of Athens "Laiko" ( Site 0704)
Athens, Attica, 115 26, Greece
University Hospital of Alexandroupolis ( Site 0701)
Alexandroupoli, East Macedonia and Thrace, 681 00, Greece
University Hospital of Ioannina ( Site 0702)
Ioannina, 455 00, Greece
Queen Mary Hospital ( Site 3300)
Hong Kong, Hong Kong
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503)
Haifa, 3109601, Israel
Bnai Zion Medical Center ( Site 1505)
Haifa, 3339419, Israel
Hadassah Medical Center-Hemato-Oncology ( Site 1500)
Jerusalem, 9112001, Israel
Galilee Medical Center ( Site 1507)
Nahariya, 2201202, Israel
Rabin Medical Center ( Site 1504)
Petah Tikva, 4941492, Israel
Sheba Medical Center-Hemato Oncology ( Site 1501)
Ramat Gan, 5265601, Israel
Yitzhak Shamir Medical Center. ( Site 1506)
Ẕerifin, 7033001, Israel
Nagoya University Hospital ( Site 1907)
Nagoya, Aichi-ken, 466-8560, Japan
Gunma University Hospital ( Site 1903)
Maebashi, Gunma, 371-8511, Japan
Hokkaido University Hospital ( Site 1900)
Sapporo, Hokkaido, 060-8648, Japan
Kobe City Medical Center General Hospital ( Site 1910)
Kobe, Hyōgo, 650-0047, Japan
Tohoku University Hospital ( Site 1901)
Sendai, Miyagi, 980-8574, Japan
Kindai University Hospital ( Site 1909)
Sakai, Osaka, 590-0197, Japan
Shimane University Hospital ( Site 1911)
Izumo, Shimane, 693-8501, Japan
Cancer Institute Hospital of JFCR ( Site 1906)
Koto, Tokyo, 135-8550, Japan
Chiba Cancer Center ( Site 1905)
Chiba, 260-8717, Japan
Kyushu University Hospital ( Site 1914)
Fukuoka, 812-8582, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913)
Hiroshima, 730-8619, Japan
Okayama University Hospital ( Site 1912)
Okayama, 700-8558, Japan
Japanese Red Cross Osaka Hospital ( Site 1908)
Osaka, 543-8555, Japan
Yamagata University Hospital ( Site 1902)
Yamagata, 990-9585, Japan
University Malaya Medical Centre ( Site 1604)
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
Hospital Pulau Pinang ( Site 1602)
George Town, Pulau Pinang, 10450, Malaysia
Queen Elizabeth Hospital ( Site 1603)
Kota Kinabalu, Sabah, 88586, Malaysia
Centro de Infusion Superare ( Site 2602)
Mexico City, Mexico City, 03100, Mexico
Health Pharma Professional Research S.A. de C.V: ( Site 2608)
Mexico City, Mexico City, 03100, Mexico
Grupo Médico ASSET ( Site 2611)
Mexico City, 3100, Mexico
Waikato Hospital-Haematology ( Site 3202)
Hamilton, Waikato Region, 3240, New Zealand
North Shore Hospital-Department of Haematology ( Site 3200)
Auckland, 0622, New Zealand
Aotearoa Clinical Trials ( Site 3201)
Auckland, 2025, New Zealand
Akershus Universitetssykehus ( Site 0902)
Lørenskog, Akershus, 1474, Norway
Sykehuset i Vestfold ( Site 0903)
Tønsberg, Vestfold, 3103, Norway
Oslo Universitetssykehus Rikshospitalet-Avdeling for blodsykdommer ( Site 0901)
Oslo, 0372, Norway
Centro Medico Monte Carmelo-Oncology ( Site 2706)
Arequipa, Ariqipa, 054, Peru
Clínica Anglo Americana ( Site 2701)
Lima, 15073, Peru
Pratia MCM Krakow ( Site 1007)
Krakow, Lesser Poland Voivodeship, 30-727, Poland
Uniwersytecki Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii-Transplantacji Szpiku i Chem ( Site 1006)
Lublin, Lublin Voivodeship, 20-081, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1004)
Warsaw, Masovian Voivodeship, 02-781, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011)
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oddział Hematologii i Transplantacji ( Site 1013)
Słupsk, Pomeranian Voivodeship, 76-200, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000)
Gliwice, Silesian Voivodeship, 44-101, Poland
Pratia Onkologia Katowice ( Site 1009)
Katowice, Silesian Voivodeship, 40-519, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1005)
Olsztyn, Warmian-Masurian Voivodeship, 10-228, Poland
Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3103)
Lisbon, Lisbon District, 1099-023, Portugal
Champalimaud Foundation ( Site 3102)
Lisbon, Lisbon District, 1400-038, Portugal
Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 3107)
Vila Nova de Gaia, Porto District, 4434-502, Portugal
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104)
Lisbon, 1449-005, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106)
Lisbon, 1649-035, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100)
Porto, 4200-072, Portugal
Wits Clinical Research ( Site 1102)
Johannesburg, Gauteng, 1864, South Africa
Netcare Pretoria East Hospital-Alberts Cellular Therapy ( Site 1101)
Pretoria, Gauteng, 0181, South Africa
Groote Schuur Hospital-Clinical Haematology ( Site 1100)
Cape Town, Western Cape, 7925, South Africa
Haemalife ( Site 1105)
Kuilsriver, Western Cape, 7580, South Africa
Constantiaberg Haematology ( Site 1106)
Plumstead, Western Cape, 7800, South Africa
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207)
L'Hospitalet Del Llobregat, Barcelona, 08908, Spain
HOSPITAL CLÍNIC DE BARCELONA ( Site 1202)
Barcelona, Catalonia, 08036, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209)
Pozuelo de Alarcón, Madrid, 28223, Spain
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208)
Majadahonda, Madrid, Comunidad de, 28220, Spain
hospital universitario de canarias ( Site 1205)
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206)
Barcelona, 08035, Spain
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201)
Salamanca, 37007, Spain
Karolinska Universitetssjukhuset Solna ( Site 1302)
Stockholm, Stockholm County, 171 64, Sweden
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702)
Kaohsiung City, 833, Taiwan
National Cheng Kung University Hospital ( Site 1700)
Tainan, 704302, Taiwan
National Taiwan University Hospital ( Site 1701)
Taipei, 10048, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 1703)
Taoyuan District, 33305, Taiwan
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801)
Bangkok, Bangkok, 10700, Thailand
Chulalongkorn University ( Site 1802)
Pathumwan, Bangkok, 10330, Thailand
Naresuan University Hospital ( Site 1804)
Muang, Changwat Phitsanulok, 65000, Thailand
Songklanagarind hospital ( Site 1803)
Hat Yai, Changwat Songkhla, 90110, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 1800)
Muang, Chiang Mai, 50200, Thailand
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401)
Ankara, 06100, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1407)
Ankara, 06800, Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi ( Site 1409)
Antalya, 7100, Turkey (Türkiye)
Trakya University Medical Faculty Hospital-Hematology ( Site 1403)
Edirne, 22030, Turkey (Türkiye)
Mega Medipol ( Site 1412)
Istanbul, 34214, Turkey (Türkiye)
Sisli Florence Nightingale Hastanesi ( Site 1411)
Istanbul, 34381, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1408)
Istanbul, 34899, Turkey (Türkiye)
Ege Universitesi Hastanesi ( Site 1404)
Izmir, 35100, Turkey (Türkiye)
Ondokuz Mays Üniversitesi ( Site 1410)
Samsun, 55280, Turkey (Türkiye)
Southmead Hospital ( Site 3010)
Bristol, Bristol, City of, BS10 5NB, United Kingdom
Royal Lancaster Infirmary ( Site 3012)
Lancaster, Lancashire, LA1 4RP, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006)
London, London, City of, EC1A 7BE, United Kingdom
The Churchill Hospital ( Site 3007)
Oxford, Oxfordshire, OX3 7LE, United Kingdom
GenesisCare - Bristol ( Site 3011)
Bristol, South Gloucestershire, BS32 4SY, United Kingdom
GenesisCare - Cambridge ( Site 3001)
Newmarket, Suffolk, CB8 7XN, United Kingdom
GenesisCare - Windsor ( Site 3002)
Windsor, Windsor And Maidenhead, SL4 3HD, United Kingdom
Barnet Hospital ( Site 3005)
Barnet, EN5 3DJ, United Kingdom
St James's University Hospital ( Site 3004)
Leeds, LS9 7TF, United Kingdom
City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003)
Nottingham, NG5 1PB, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2023
First Posted
November 18, 2023
Study Start
December 13, 2023
Primary Completion (Estimated)
September 7, 2032
Study Completion (Estimated)
September 7, 2032
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf