Recruiting

Phase 3

Nemtabrutinib vs. Ibrutinib & AcalabrutinibA 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

Code:

NCT06136559

Conditions

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nemtabrutinib

Ibrutinib

Acalabrutinib

Study Details

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.

Conditions

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Study ID

NCT06136559

Start date

Dec 13, 2023

Status verified date

Aug, 2026

Completion date

Sep 7, 2032

Anticipated

Primary completion date

Sep 7, 2032

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nemtabrutinib

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

active comparator: 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.

Interventions

Nemtabrutinib

Administered orally

Ibrutinib

Administered orally

Acalabrutinib

Administered orally

Primary outcome measure

Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to ~33 months ]
Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by BICR [ Time Frame: Up to ~104 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

USA Mitchell Cancer Institute ( Site 0014)

Recruiting

Mobile, Alabama, United States, 36604

Contacts

Study Coordinator

251-665-8000

Banner MD Anderson Cancer Center ( Site 0059)

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Study Coordinator

480-256-5490

Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Study Coordinator

480-256-5490

Moores Cancer Center ( Site 0003)

Recruiting

La Jolla, California, United States, 92093-0698

Contacts

Study Coordinator

858-534-5201

Care Access - South Pasadena ( Site 0070)

Recruiting

Pasadena, California, United States, 91105

Contacts

Study Coordinator

626-556-9930

Saint Joseph Hospital ( Site 0026)

Recruiting

Denver, Colorado, United States, 80218

Contacts

Study Coordinator

303-403-6381

Lutheran Medical Center ( Site 0027)

Recruiting

Golden, Colorado, United States, 80401

Contacts

Study Coordinator

303-403-6381

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

Recruiting

Grand Junction, Colorado, United States, 81501

Contacts

Study Coordinator

970-298-7638

Eastern CT Hematology & Oncology Associates ( Site 0033)

Recruiting

Norwich, Connecticut, United States, 06360

Contacts

Study Coordinator

860-886-8362

Lynn Cancer Center at Boca Raton Regional Hospital ( Site 0063)

Recruiting

Boca Raton, Florida, United States, 33486

Contacts

Study Coordinator

561-955-4800

Clermont Oncology Center ( Site 0046)

Recruiting

Clermont, Florida, United States, 34711

Contacts

Study Coordinator

386-538-3169

Florida Cancer Specialists - South ( Site 7001)

Recruiting

Fort Myers, Florida, United States, 33901

Contacts

Study Coordinator

239-274-9930

Florida Cancer Specialists - East ( Site 7002)

Recruiting

West Palm Beach, Florida, United States, 33401

Contacts

Study Coordinator

727-216-1143

Saint Alphonsus Regional Medical Center ( Site 0067)

Recruiting

Boise, Idaho, United States, 83706

Contacts

Study Coordinator

208-367-3131

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

Recruiting

Fort Wayne, Indiana, United States, 46845

Contacts

Study Coordinator

260-266-7100

University of Iowa Health Care. ( Site 0017)

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Study Coordinator

319-356-1616

University of Iowa Health Care. ( Site 0057)

Recruiting

Waukee, Iowa, United States, 50263

Contacts

Study Coordinator

319-356-1616

Saint Elizabeth Healthcare ( Site 0041)

Recruiting

Edgewood, Kentucky, United States, 41017

Contacts

Study Coordinator

859-301-2000

Owensboro Medical Health System ( Site 0066)

Recruiting

Owensboro, Kentucky, United States, 42303

Contacts

Study Coordinator

270-688-1938

Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Study Coordinator

616-267-7566

Regions Hospital ( Site 0042)

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Study Coordinator

952-993-3252

MidAmerica Cancer Care, LLC ( Site 0043)

Recruiting

Kansas City, Missouri, United States, 64132

Contacts

Study Coordinator

816-974-5050

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052)

Recruiting

Billings, Montana, United States, 59102

Contacts

Study Coordinator

406-238-6685

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

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-3277

New York Oncology Hematology, P.C. ( Site 0069)

Recruiting

Albany, New York, United States, 12208

Contacts

Study Coordinator

518-262-6696

Roswell Park Cancer Institute ( Site 0023)

Recruiting

Buffalo, New York, United States, 14263

Contacts

Study Coordinator

716-845-2300

RPCI Oncology, PC- Northtowns ( Site 0061)

Recruiting

Williamsville, New York, United States, 14221

Contacts

Study Coordinator

716-634-3340

Carolina Oncology Specialists, PA ( Site 0054)

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Study Coordinator

704-342-1900

Southeastern Medical Oncology Center ( Site 0049)

Recruiting

Goldsboro, North Carolina, United States, 27534

Contacts

Study Coordinator

919-587-9088

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

Recruiting

Broomall, Pennsylvania, United States, 19008

Contacts

Study Coordinator

610-585-6287

Cancer Care Associates Of York ( Site 0005)

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Study Coordinator

717-741-9229

Tennessee Oncology-Chattanooga ( Site 0045)

Recruiting

Chattanooga, Tennessee, United States, 37404

Contacts

Study Coordinator

615-986-4350

Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0031)

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

615-986-4350

Texas Oncology - Central/South Texas ( Site 8008)

Recruiting

Austin, Texas, United States, 78705

Contacts

Study Coordinator

512-421-4100

The Center for Cancer and Blood Disorders ( Site 0032)

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Study Coordinator

817-759-7013

Texas Oncology - San Antonio ( Site 8006)

Recruiting

San Antonio, Texas, United States, 78217

Contacts

Study Coordinator

210-419-2608

Texas Oncology - Northeast Texas ( Site 8012)

Recruiting

Tyler, Texas, United States, 75702

Contacts

Study Coordinator

903-579-9800

University of Virginia Cancer Center ( Site 0040)

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Study Coordinator

434-243-2649

Inova Schar Cancer Institute ( Site 0015)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

571-472-4724

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

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Study Coordinator

804-628-2072

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

Recruiting

Spokane, Washington, United States, 99208

Contacts

Study Coordinator

509-462-2273

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

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Study Coordinator

608-410-2700

University Hospital and UW Health Clinics ( Site 0006)

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Study Coordinator

608-263-6400

BC Cancer Kelowna ( Site 0112)

Recruiting

Kelowna, British Columbia, Canada, V1Y 5L3

Contacts

Study Coordinator

250-717-4294

BC Cancer Victoria ( Site 0109)

Recruiting

Victoria, British Columbia, Canada, V8R 6V5

Contacts

Study Coordinator

250-519-5500

William Osler Health System ( Site 0103)

Recruiting

Brampton, Ontario, Canada, L6R 3J7

Contacts

Study Coordinator

905-494-2120

The Ottawa Hospital - General Campus ( Site 0102)

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Study Coordinator

613-737-8899 x79509

McGill University Health Centre ( Site 0106)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Study Coordinator

514-934-1934

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-27.