NCT06136559From ClinicalTrials.govRecruiting

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)

Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Merck Sharp & Dohme LLC
Enrolment target: 1,200
Started: 13 December 2023
Main results due: 7 September 2032
Study sites: 203
Registry updated: 24 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* 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:

The main exclusion criteria include but are not limited to the following:

* 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(203)

USA Mitchell Cancer Institute ( Site 0014)
Mobile, Alabama, United States
Recruiting
Banner MD Anderson Cancer Center ( Site 0059)
Gilbert, Arizona, United States
Recruiting
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)
Phoenix, Arizona, United States
Recruiting
Arizona Oncology Associates - NAHOA ( Site 8007)
Prescott, Arizona, United States
Completed
Alta Bates Summit Medical Center ( Site 0004)
Berkeley, California, United States
Active, not recruiting
Moores Cancer Center ( Site 0003)
La Jolla, California, United States
Recruiting
Care Access - South Pasadena ( Site 0070)
Pasadena, California, United States
Recruiting
Saint Joseph Hospital ( Site 0026)
Denver, Colorado, United States
Recruiting
Lutheran Medical Center ( Site 0027)
Golden, Colorado, United States
Recruiting
Intermountain Health St. Mary's Regional Hospital ( Site 0025)
Grand Junction, Colorado, United States
Recruiting
Eastern CT Hematology & Oncology Associates ( Site 0033)
Norwich, Connecticut, United States
Recruiting
Lynn Cancer Center at Boca Raton Regional Hospital ( Site 0063)
Boca Raton, Florida, United States
Recruiting
Clermont Oncology Center ( Site 0046)
Clermont, Florida, United States
Recruiting
Florida Cancer Specialists - South ( Site 7001)
Fort Myers, Florida, United States
Recruiting
Florida Cancer Specialists - East ( Site 7002)
West Palm Beach, Florida, United States
Recruiting
Saint Alphonsus Regional Medical Center ( Site 0067)
Boise, Idaho, United States
Recruiting
Parkview Research Center at Parkview Regional Medical Center ( Site 0002)
Fort Wayne, Indiana, United States
Recruiting
University of Iowa Health Care. ( Site 0017)
Iowa City, Iowa, United States
Recruiting
University of Iowa Health Care. ( Site 0057)
Waukee, Iowa, United States
Recruiting
Saint Elizabeth Healthcare ( Site 0041)
Edgewood, Kentucky, United States
Recruiting
Owensboro Medical Health System ( Site 0066)
Owensboro, Kentucky, United States
Recruiting
Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)
Grand Rapids, Michigan, United States
Recruiting
Regions Hospital ( Site 0042)
Saint Louis Park, Minnesota, United States
Recruiting
MidAmerica Cancer Care, LLC ( Site 0043)
Kansas City, Missouri, United States
Recruiting
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052)
Billings, Montana, United States
Recruiting
Summit Medical Group Cancer Center ( Site 0007)
Florham Park, New Jersey, United States
Completed
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
Hackensack, New Jersey, United States
Recruiting
New York Oncology Hematology, P.C. ( Site 0069)
Albany, New York, United States
Recruiting
Roswell Park Cancer Institute ( Site 0023)
Buffalo, New York, United States
Recruiting
RPCI Oncology, PC- Northtowns ( Site 0061)
Williamsville, New York, United States
Recruiting
Carolina Oncology Specialists, PA ( Site 0054)
Charlotte, North Carolina, United States
Recruiting
Southeastern Medical Oncology Center ( Site 0049)
Goldsboro, North Carolina, United States
Recruiting
Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002)
Broomall, Pennsylvania, United States
Recruiting
Cancer Care Associates Of York ( Site 0005)
York, Pennsylvania, United States
Recruiting
Tennessee Oncology-Chattanooga ( Site 0045)
Chattanooga, Tennessee, United States
Recruiting
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0031)
Nashville, Tennessee, United States
Recruiting
Texas Oncology - Central/South Texas ( Site 8008)
Austin, Texas, United States
Recruiting
The Center for Cancer and Blood Disorders ( Site 0032)
Fort Worth, Texas, United States
Recruiting
Texas Oncology - San Antonio ( Site 8006)
San Antonio, Texas, United States
Recruiting
Texas Oncology - Northeast Texas ( Site 8012)
Tyler, Texas, United States
Recruiting
University of Virginia Cancer Center ( Site 0040)
Charlottesville, Virginia, United States
Recruiting
Inova Schar Cancer Institute ( Site 0015)
Fairfax, Virginia, United States
Recruiting
Virginia Commonwealth University (VCU) Medical Center ( Site 0030)
Richmond, Virginia, United States
Recruiting
Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)
Spokane, Washington, United States
Recruiting
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048)
Madison, Wisconsin, United States
Recruiting
University Hospital and UW Health Clinics ( Site 0006)
Madison, Wisconsin, United States
Recruiting
Royal North Shore Hospital ( Site 2806)
St Leonards, New South Wales, Australia
Completed
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)
Mechelen, Antwerpen, Belgium
Recruiting
UZ Leuven-Hematology ( Site 0200)
Leuven, Vlaams-Brabant, Belgium
Recruiting
Hospital Erasto Gaertner ( Site 2212)
Curitiba, Paraná, Brazil
Recruiting
Hope - Humanizacao Em Oncologia, Pesquisa E Ensino ( Site 2211)
Ribeirão Preto, São Paulo, Brazil
Recruiting
Hospital 9 De Julho ( Site 2206)
São Paulo, São Paulo, Brazil
Recruiting
Instituto Nacional de Câncer - INCA ( Site 2201)
Rio de Janeiro, Brazil
Recruiting
Hospital Paulistano-Americas Oncologia ( Site 2202)
São Paulo, Brazil
Recruiting
BC Cancer Kelowna ( Site 0112)
Kelowna, British Columbia, Canada
Recruiting
BC Cancer Victoria ( Site 0109)
Victoria, British Columbia, Canada
Recruiting
William Osler Health System ( Site 0103)
Brampton, Ontario, Canada
Recruiting
The Ottawa Hospital - General Campus ( Site 0102)
Ottawa, Ontario, Canada
Recruiting
McGill University Health Centre ( Site 0106)
Montreal, Quebec, Canada
Recruiting
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100)
Rimouski, Quebec, Canada
Completed

Showing 60 of 203 sites — filter to narrow it down. 178 of the 203 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06136559. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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