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NCT06136559

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)

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-13

Study Completion Date

2032-09-07

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nemtabrutinib

Participants will receive nemtabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met.

Group Type EXPERIMENTAL

Nemtabrutinib

Intervention Type DRUG

Administered orally

Ibrutinib/Acalabrutinib

Participants will receive investigator's choice of ibrutinib or acalabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met.

Group Type ACTIVE_COMPARATOR

Ibrutinib

Intervention Type DRUG

Administered orally

Acalabrutinib

Intervention Type DRUG

Administered orally

Interventions

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Nemtabrutinib

Administered orally

Intervention Type DRUG

Ibrutinib

Administered orally

Intervention Type DRUG

Acalabrutinib

Administered orally

Intervention Type DRUG

Other Intervention Names

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MK-1026 ARQ 531

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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USA Mitchell Cancer Institute ( Site 0014)

Mobile, Alabama, United States

Site Status RECRUITING

Arizona Oncology Associates - NAHOA ( Site 8007)

Prescott, Arizona, United States

Site Status RECRUITING

Alta Bates Summit Medical Center ( Site 0004)

Berkeley, California, United States

Site Status RECRUITING

Moores Cancer Center ( Site 0003)

La Jolla, California, United States

Site Status RECRUITING

Saint Joseph Hospital ( Site 0026)

Denver, Colorado, United States

Site Status RECRUITING

Lutheran Medical Center ( Site 0027)

Golden, Colorado, United States

Site Status RECRUITING

Intermountain Health St. Mary's Regional Hospital ( Site 0025)

Grand Junction, Colorado, United States

Site Status RECRUITING

Eastern CT Hematology & Oncology Associates ( Site 0033)

Norwich, Connecticut, United States

Site Status RECRUITING

Clermont Oncology Center ( Site 0046)

Clermont, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists - South ( Site 7001)

Fort Myers, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists - East ( Site 7002)

West Palm Beach, Florida, United States

Site Status RECRUITING

Parkview Research Center at Parkview Regional Medical Center ( Site 0002)

Fort Wayne, Indiana, United States

Site Status RECRUITING

University of Iowa-Holden Comprehensive Cancer Center ( Site 0017)

Iowa City, Iowa, United States

Site Status RECRUITING

Saint Elizabeth Healthcare ( Site 0041)

Edgewood, Kentucky, United States

Site Status RECRUITING

Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)

Grand Rapids, Michigan, United States

Site Status RECRUITING

Regions Hospital ( Site 0042)

Saint Louis Park, Minnesota, United States

Site Status RECRUITING

MidAmerica Cancer Care, LLC ( Site 0043)

Kansas City, Missouri, United States

Site Status RECRUITING

Summit Medical Group Cancer Center ( Site 0007)

Florham Park, New Jersey, United States

Site Status COMPLETED

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)

Hackensack, New Jersey, United States

Site Status RECRUITING

Roswell Park Cancer Institute ( Site 0023)

Buffalo, New York, United States

Site Status RECRUITING

Oncology Specialists of Charlotte ( Site 0054)

Charlotte, North Carolina, United States

Site Status RECRUITING

Southeastern Medical Oncology Center ( Site 0049)

Goldsboro, North Carolina, United States

Site Status RECRUITING

Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002)

Broomall, Pennsylvania, United States

Site Status RECRUITING

Cancer Care Associates Of York ( Site 0005)

York, Pennsylvania, United States

Site Status RECRUITING

Tennessee Oncology-Chattanooga ( Site 0045)

Chattanooga, Tennessee, United States

Site Status RECRUITING

TENNESSEE ONCOLOGY ( Site 0031)

Nashville, Tennessee, United States

Site Status RECRUITING

Texas Oncology - Central/South Texas ( Site 8008)

Austin, Texas, United States

Site Status RECRUITING

The Center for Cancer and Blood Disorders ( Site 0032)

Fort Worth, Texas, United States

Site Status RECRUITING

Texas Oncology - San Antonio ( Site 8006)

San Antonio, Texas, United States

Site Status RECRUITING

Texas Oncology - Northeast Texas ( Site 8012)

Tyler, Texas, United States

Site Status RECRUITING

University of Virginia Cancer Center ( Site 0040)

Charlottesville, Virginia, United States

Site Status RECRUITING

Inova Schar Cancer Institute ( Site 0015)

Fairfax, Virginia, United States

Site Status RECRUITING

Virginia Commonwealth University (VCU) Medical Center ( Site 0030)

Richmond, Virginia, United States

Site Status RECRUITING

Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)

Spokane, Washington, United States

Site Status RECRUITING

SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048)

Madison, Wisconsin, United States

Site Status RECRUITING

University Hospital and UW Health Clinics ( Site 0006)

Madison, Wisconsin, United States

Site Status RECRUITING

Royal North Shore Hospital ( Site 2806)

St Leonards, New South Wales, Australia

Site Status COMPLETED

AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)

Mechelen, Antwerpen, Belgium

Site Status RECRUITING

UZ Leuven-Hematology ( Site 0200)

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

Hospital 9 De Julho ( Site 2206)

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Instituto Nacional de Câncer - INCA ( Site 2201)

Rio de Janeiro, , Brazil

Site Status RECRUITING

Hospital Paulistano-Americas Oncologia ( Site 2202)

São Paulo, , Brazil

Site Status RECRUITING

BC Cancer Kelowna ( Site 0112)

Kelowna, British Columbia, Canada

Site Status RECRUITING

BC Cancer Victoria ( Site 0109)

Victoria, British Columbia, Canada

Site Status RECRUITING

William Osler Health System ( Site 0103)

Brampton, Ontario, Canada

Site Status RECRUITING

The Ottawa Hospital - General Campus ( Site 0102)

Ottawa, Ontario, Canada

Site Status RECRUITING

McGill University Health Centre ( Site 0106)

Montreal, Quebec, Canada

Site Status RECRUITING

Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100)

Rimouski, Quebec, Canada

Site Status COMPLETED

FALP-UIDO ( Site 2300)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Bradfordhill-Clinical Area ( Site 2310)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Anhui Provincial Cancer Hospital ( Site 2001)

Hefei, Anhui, China

Site Status RECRUITING

Peking University First Hospital ( Site 2022)

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking University Third Hospital-Hematology ( Site 2011)

Beijing, Beijing Municipality, China

Site Status RECRUITING

Chongqing University Cancer Hospital ( Site 2041)

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006)

Guangzhou, Guangdong, China

Site Status RECRUITING

Sun Yat-sen University Cancer Center ( Site 2028)

Guangzhou, Guangdong, China

Site Status RECRUITING

Liuzhou People's Hospital ( Site 2029)

Liuzhou, Guangxi, China

Site Status RECRUITING

Guangxi Medical University Affiliated Tumor Hospital ( Site 2004)

Nanning, Guangxi, China

Site Status RECRUITING

The Affiliated Hospital of Guizhou Medical University ( Site 2024)

Guiyang, Guizhou, China

Site Status RECRUITING

Hainan General Hospital ( Site 2018)

Haikou, Hainan, China

Site Status RECRUITING

Wuhan Union Hospital ( Site 2015)

Wuhan, Hebei, China

Site Status RECRUITING

Henan Cancer Hospital-hematology department ( Site 2025)

Zhengzhou, Henan, China

Site Status RECRUITING

Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016)

Wuhan, Hubei, China

Site Status RECRUITING

Hunan Cancer Hospital ( Site 2020)

Changsha, Hunan, China

Site Status RECRUITING

The Second Xiangya Hospital of Central South University ( Site 2010)

Changsha, Hunan, China

Site Status RECRUITING

Jiangsu Province Hospital ( Site 2000)

Nanjing, Jiangsu, China

Site Status RECRUITING

The First Affliated Hospital of Suzhou University ( Site 2027)

Suzhou, Jiangsu, China

Site Status RECRUITING

The Affiliated Hospital of Xuzhou Medical College ( Site 2013)

Xuzhou, Jiangsu, China

Site Status RECRUITING

The First Affiliated Hospital of Nanchang University ( Site 2023)

Nanchang, Jiangxi, China

Site Status RECRUITING

Jiangxi Provincial Cancer Hospital ( Site 2009)

Nanchang, Jiangxi, China

Site Status RECRUITING

The First Hospital of Jilin University-Hematology ( Site 2030)

Changchun, Jilin, China

Site Status RECRUITING

Shaanxi provincial people's hospital ( Site 2012)

Xi'an, Shaanxi, China

Site Status RECRUITING

Shandong Cancer Hospital ( Site 2003)

Jinan, Shandong, China

Site Status RECRUITING

Shanxi Cancer Hospital ( Site 2033)

Taiyuan, Shanxi, China

Site Status RECRUITING

West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026)

Chengdu, Sichuan, China

Site Status RECRUITING

Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019)

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Institute of hematology&blood disease hospital-Lymphoma ( Site 2005)

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014)

Ürümqi, Xinjiang, China

Site Status RECRUITING

The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002)

Hangzhou, Zhejiang, China

Site Status RECRUITING

Zhejiang Cancer Hospital ( Site 2017)

Hangzhou, Zhejiang, China

Site Status RECRUITING

Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405)

Valledupar, Cesar Department, Colombia

Site Status RECRUITING

IMAT S.A.S ( Site 2401)

Montería, Departamento de Córdoba, Colombia

Site Status RECRUITING

Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402)

Cali, Valle del Cauca Department, Colombia

Site Status RECRUITING

Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301)

Hradec Králové, , Czechia

Site Status RECRUITING

Fakultni nemocnice Olomouc ( Site 0303)

Olomouc, , Czechia

Site Status RECRUITING

Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)

Prague, , Czechia

Site Status RECRUITING

Aalborg Universitetshospital, Syd ( Site 0403)

Aalborg, North Denmark, Denmark

Site Status RECRUITING

Roskilde Sygehus-Department of Hematology ( Site 0402)

Roskilde, Region Sjælland, Denmark

Site Status RECRUITING

Odense Universitetshospital-Department of Hematology ( Site 0401)

Odense C, Region Syddanmark, Denmark

Site Status RECRUITING

Universitaetsklinikum Ulm. ( Site 0601)

Ulm, Baden-Wurttemberg, Germany

Site Status RECRUITING

VK&K Studien GbR ( Site 0607)

Landshut, Bavaria, Germany

Site Status RECRUITING

Kliniken Maria Hilf ( Site 0603)

Mönchengladbach, North Rhine-Westphalia, Germany

Site Status RECRUITING

InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606)

Koblenz, Rhineland-Palatinate, Germany

Site Status RECRUITING

Universitätsklinikum Halle ( Site 0604)

Halle, Saxony-Anhalt, Germany

Site Status RECRUITING

Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600)

Berlin, , Germany

Site Status RECRUITING

Evangelismos General Hospital of Athens ( Site 0700)

Athens, Attica, Greece

Site Status RECRUITING

General Hospital of Athens "Laiko" ( Site 0704)

Athens, Attica, Greece

Site Status RECRUITING

University Hospital of Alexandroupolis ( Site 0701)

Alexandroupoli, East Macedonia and Thrace, Greece

Site Status RECRUITING

University Hospital of Ioannina ( Site 0702)

Ioannina, , Greece

Site Status RECRUITING

Queen Mary Hospital ( Site 3300)

Hong Kong, , Hong Kong

Site Status RECRUITING

Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503)

Haifa, , Israel

Site Status RECRUITING

Bnai Zion Medical Center ( Site 1505)

Haifa, , Israel

Site Status RECRUITING

Hadassah Medical Center-Hemato-Oncology ( Site 1500)

Jerusalem, , Israel

Site Status RECRUITING

Galilee Medical Center ( Site 1507)

Nahariya, , Israel

Site Status RECRUITING

Rabin Medical Center ( Site 1504)

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center-Hemato Oncology ( Site 1501)

Ramat Gan, , Israel

Site Status RECRUITING

Yitzhak Shamir Medical Center. ( Site 1506)

Ẕerifin, , Israel

Site Status RECRUITING