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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)

RecruitingPhase 3

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)

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 1,200 · Started: Dec 13, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06136559

Locations in the U.S.

AlabamaUSA Mitchell Cancer Institute ( Site 0014), Mobile
ArizonaBanner MD Anderson Cancer Center ( Site 0059), Gilbert
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051), Phoenix
CaliforniaMoores Cancer Center ( Site 0003), La Jolla
Care Access - South Pasadena ( Site 0070), Pasadena
ColoradoSaint Joseph Hospital ( Site 0026), Denver
Lutheran Medical Center ( Site 0027), Golden
Intermountain Health St. Mary's Regional Hospital ( Site 0025), Grand Junction
ConnecticutEastern CT Hematology & Oncology Associates ( Site 0033), Norwich
FloridaLynn Cancer Center at Boca Raton Regional Hospital ( Site 0063), Boca Raton
Clermont Oncology Center ( Site 0046), Clermont
Florida Cancer Specialists - South ( Site 7001), Fort Myers
Florida Cancer Specialists - East ( Site 7002), West Palm Beach
IdahoSaint Alphonsus Regional Medical Center ( Site 0067), Boise
IndianaParkview Research Center at Parkview Regional Medical Center ( Site 0002), Fort Wayne
IowaUniversity of Iowa Health Care. ( Site 0017), Iowa City
University of Iowa Health Care. ( Site 0057), Waukee
KentuckySaint Elizabeth Healthcare ( Site 0041), Edgewood
Owensboro Medical Health System ( Site 0066), Owensboro
MichiganCorewell Health-Lemmon Holton Cancer Pavilion ( Site 0011), Grand Rapids
MinnesotaRegions Hospital ( Site 0042), Saint Louis Park
MissouriMidAmerica Cancer Care, LLC ( Site 0043), Kansas City
MontanaIntermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052), Billings
New JerseyJohn Theurer Cancer Center at Hackensack University Medical Center ( Site 0016), Hackensack
New YorkNew York Oncology Hematology, P.C. ( Site 0069), Albany
Roswell Park Cancer Institute ( Site 0023), Buffalo
RPCI Oncology, PC- Northtowns ( Site 0061), Williamsville
North CarolinaCarolina Oncology Specialists, PA ( Site 0054), Charlotte
Southeastern Medical Oncology Center ( Site 0049), Goldsboro
PennsylvaniaConsultants in Medical Oncology and Hematology (CMOH) ( Site 8002), Broomall
Cancer Care Associates Of York ( Site 0005), York
TennesseeTennessee Oncology-Chattanooga ( Site 0045), Chattanooga
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0031), Nashville
TexasTexas Oncology - Central/South Texas ( Site 8008), Austin
The Center for Cancer and Blood Disorders ( Site 0032), Fort Worth
Texas Oncology - San Antonio ( Site 8006), San Antonio
Texas Oncology - Northeast Texas ( Site 8012), Tyler
VirginiaUniversity of Virginia Cancer Center ( Site 0040), Charlottesville
Inova Schar Cancer Institute ( Site 0015), Fairfax
Virginia Commonwealth University (VCU) Medical Center ( Site 0030), Richmond
WashingtonMedical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010), Spokane
WisconsinSSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048), Madison
University Hospital and UW Health Clinics ( Site 0006), Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.