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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)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1200
Start Date
2023-12-13
Completion Date
2032-09-07
Last Updated
2026-10-13
Healthy Volunteers
No
Interventions
Nemtabrutinib
Administered orally
Ibrutinib
Administered orally
Acalabrutinib
Administered orally
Locations (206)
USA Mitchell Cancer Institute ( Site 0014)
Mobile, Alabama, United States
Banner MD Anderson Cancer Center ( Site 0059)
Gilbert, Arizona, United States
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)
Phoenix, Arizona, United States
Arizona Oncology Associates - NAHOA ( Site 8007)
Prescott, Arizona, United States
Alta Bates Summit Medical Center ( Site 0004)
Berkeley, California, United States
Moores Cancer Center ( Site 0003)
La Jolla, California, United States
Care Access - South Pasadena ( Site 0070)
Pasadena, California, United States
Saint Joseph Hospital ( Site 0026)
Denver, Colorado, United States
Lutheran Medical Center ( Site 0027)
Golden, Colorado, United States
Intermountain Health St. Mary's Regional Hospital ( Site 0025)
Grand Junction, Colorado, United States
Eastern CT Hematology & Oncology Associates ( Site 0033)
Norwich, Connecticut, United States
Lynn Cancer Center at Boca Raton Regional Hospital ( Site 0063)
Boca Raton, Florida, United States
Clermont Oncology Center ( Site 0046)
Clermont, Florida, United States
Florida Cancer Specialists - South ( Site 7001)
Fort Myers, Florida, United States
Florida Cancer Specialists - East ( Site 7002)
West Palm Beach, Florida, United States
Saint Alphonsus Regional Medical Center ( Site 0067)
Boise, Idaho, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0002)
Fort Wayne, Indiana, United States
University of Iowa Health Care. ( Site 0017)
Iowa City, Iowa, United States
University of Iowa Health Care. ( Site 0057)
Waukee, Iowa, United States
Saint Elizabeth Healthcare ( Site 0041)
Edgewood, Kentucky, United States
Owensboro Medical Health System ( Site 0066)
Owensboro, Kentucky, United States
Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)
Grand Rapids, Michigan, United States
Regions Hospital ( Site 0042)
Saint Louis Park, Minnesota, United States
MidAmerica Cancer Care, LLC ( Site 0043)
Kansas City, Missouri, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052)
Billings, Montana, United States
Summit Medical Group Cancer Center ( Site 0007)
Florham Park, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
Hackensack, New Jersey, United States
New York Oncology Hematology, P.C. ( Site 0069)
Albany, New York, United States
Roswell Park Cancer Institute ( Site 0023)
Buffalo, New York, United States
RPCI Oncology, PC- Northtowns ( Site 0061)
Williamsville, New York, United States
Carolina Oncology Specialists, PA ( Site 0054)
Charlotte, North Carolina, United States
Southeastern Medical Oncology Center ( Site 0049)
Goldsboro, North Carolina, United States
Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002)
Broomall, Pennsylvania, United States
Cancer Care Associates Of York ( Site 0005)
York, Pennsylvania, United States
Tennessee Oncology-Chattanooga ( Site 0045)
Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0031)
Nashville, Tennessee, United States
Texas Oncology - Central/South Texas ( Site 8008)
Austin, Texas, United States
The Center for Cancer and Blood Disorders ( Site 0032)
Fort Worth, Texas, United States
Texas Oncology - San Antonio ( Site 8006)
San Antonio, Texas, United States
Texas Oncology - Northeast Texas ( Site 8012)
Tyler, Texas, United States
University of Virginia Cancer Center ( Site 0040)
Charlottesville, Virginia, United States
Inova Schar Cancer Institute ( Site 0015)
Fairfax, Virginia, United States
Virginia Commonwealth University (VCU) Medical Center ( Site 0030)
Richmond, Virginia, United States
Swedish Cancer Institute, Edmonds Campus ( Site 0072)
Edmonds, Washington, United States
Swedish Cancer Institute, Issaquah Campus ( Site 0073)
Issaquah, Washington, United States
Swedish Medical Center-Swedish Cancer Institute ( Site 0071)
Seattle, Washington, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)
Spokane, Washington, United States
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048)
Madison, Wisconsin, United States
University Hospital and UW Health Clinics ( Site 0006)
Madison, Wisconsin, United States
Royal North Shore Hospital ( Site 2806)
St Leonards, New South Wales, Australia
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)
Mechelen, Antwerpen, Belgium
UZ Leuven-Hematology ( Site 0200)
Leuven, Vlaams-Brabant, Belgium
Hospital Erasto Gaertner ( Site 2212)
Curitiba, Paraná, Brazil
Hope - Humanizacao Em Oncologia, Pesquisa E Ensino ( Site 2211)
Ribeirão Preto, São Paulo, Brazil
Hospital 9 De Julho ( Site 2206)
São Paulo, São Paulo, Brazil
Instituto Nacional de Câncer - INCA ( Site 2201)
Rio de Janeiro, Brazil
Hospital Paulistano-Americas Oncologia ( Site 2202)
São Paulo, Brazil
BC Cancer Kelowna ( Site 0112)
Kelowna, British Columbia, Canada
BC Cancer Victoria ( Site 0109)
Victoria, British Columbia, Canada
William Osler Health System ( Site 0103)
Brampton, Ontario, Canada
The Ottawa Hospital - General Campus ( Site 0102)
Ottawa, Ontario, Canada
McGill University Health Centre ( Site 0106)
Montreal, Quebec, Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100)
Rimouski, Quebec, Canada
FALP-UIDO ( Site 2300)
Santiago, Region M. de Santiago, Chile
Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 2310)
Santiago, Region M. de Santiago, Chile
Anhui Provincial Cancer Hospital ( Site 2001)
Hefei, Anhui, China
Peking University First Hospital ( Site 2022)
Beijing, Beijing Municipality, China
Peking University Third Hospital-Hematology ( Site 2011)
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital ( Site 2041)
Chongqing, Chongqing Municipality, China
Sun Yat-sen University Cancer Center ( Site 2028)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006)
Guangzhou, Guangdong, China
Liuzhou People's Hospital ( Site 2029)
Liuzhou, Guangxi, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 2004)
Nanning, Guangxi, China
The Affiliated Hospital of Guizhou Medical University ( Site 2024)
Guiyang, Guizhou, China
Hainan General Hospital ( Site 2018)
Haikou, Hainan, China
Henan Cancer Hospital-hematology department ( Site 2025)
Zhengzhou, Henan, China
Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016)
Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 2015)
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 2020)
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University ( Site 2010)
Changsha, Hunan, China
Jiangsu Province Hospital ( Site 2000)
Nanjing, Jiangsu, China
The First Affliated Hospital of Suzhou University ( Site 2027)
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College ( Site 2013)
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University ( Site 2023)
Nanchang, Jiangxi, China
Jiangxi Provincial Cancer Hospital ( Site 2009)
Nanchang, Jiangxi, China
The First Hospital of Jilin University-Hematology ( Site 2030)
Changchun, Jilin, China
Shaanxi provincial people's hospital ( Site 2012)
Xi'an, Shaanxi, China
Shandong Cancer Hospital ( Site 2003)
Jinan, Shandong, China
Shanxi Cancer Hospital ( Site 2033)
Taiyuan, Shanxi, China
West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026)
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019)
Tianjin, Tianjin Municipality, China
Institute of hematology&blood disease hospital-Lymphoma ( Site 2005)
Tianjin, Tianjin Municipality, China
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014)
Ürümqi, Xinjiang, China
The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 2017)
Hangzhou, Zhejiang, China
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405)
Valledupar, Cesar Department, Colombia
IMAT S.A.S ( Site 2401)
Montería, Departamento de Córdoba, Colombia
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402)
Cali, Valle del Cauca Department, Colombia
Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301)
Hradec Králové, Czechia