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Clinical Trials in the UK / NCT06136559
Recruiting Phase 3

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)

NCT06136559 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2023-12-13
Last updated
2026-09-14

Condition(s) studied

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Investigational drug(s) / intervention(s)

NemtabrutinibIbrutinibAcalabrutinib

Nemtabrutinib: Administered orally

Ibrutinib: Administered orally

Acalabrutinib: Administered orally

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (203)

FacilityCityRegionStatus
USA Mitchell Cancer Institute ( Site 0014) Mobile Alabama Recruiting
Banner MD Anderson Cancer Center ( Site 0059) Gilbert Arizona Recruiting
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051) Phoenix Arizona Recruiting
Arizona Oncology Associates - NAHOA ( Site 8007) Prescott Arizona Completed
Alta Bates Summit Medical Center ( Site 0004) Berkeley California Active Not Recruiting
Moores Cancer Center ( Site 0003) La Jolla California Recruiting
Care Access - South Pasadena ( Site 0070) Pasadena California Recruiting
Saint Joseph Hospital ( Site 0026) Denver Colorado Recruiting
Lutheran Medical Center ( Site 0027) Golden Colorado Recruiting
Intermountain Health St. Mary's Regional Hospital ( Site 0025) Grand Junction Colorado Recruiting
Eastern CT Hematology & Oncology Associates ( Site 0033) Norwich Connecticut Recruiting
Lynn Cancer Center at Boca Raton Regional Hospital ( Site 0063) Boca Raton Florida Recruiting
Clermont Oncology Center ( Site 0046) Clermont Florida Recruiting
Florida Cancer Specialists - South ( Site 7001) Fort Myers Florida Recruiting
Florida Cancer Specialists - East ( Site 7002) West Palm Beach Florida Recruiting
Saint Alphonsus Regional Medical Center ( Site 0067) Boise Idaho Recruiting
Parkview Research Center at Parkview Regional Medical Center ( Site 0002) Fort Wayne Indiana Recruiting
University of Iowa Health Care. ( Site 0017) Iowa City Iowa Recruiting
University of Iowa Health Care. ( Site 0057) Waukee Iowa Recruiting
Saint Elizabeth Healthcare ( Site 0041) Edgewood Kentucky Recruiting
Owensboro Medical Health System ( Site 0066) Owensboro Kentucky Recruiting
Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011) Grand Rapids Michigan Recruiting
Regions Hospital ( Site 0042) Saint Louis Park Minnesota Recruiting
MidAmerica Cancer Care, LLC ( Site 0043) Kansas City Missouri Recruiting
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052) Billings Montana Recruiting
Summit Medical Group Cancer Center ( Site 0007) Florham Park New Jersey Completed
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016) Hackensack New Jersey Recruiting
New York Oncology Hematology, P.C. ( Site 0069) Albany New York Recruiting
Roswell Park Cancer Institute ( Site 0023) Buffalo New York Recruiting
RPCI Oncology, PC- Northtowns ( Site 0061) Williamsville New York Recruiting
Carolina Oncology Specialists, PA ( Site 0054) Charlotte North Carolina Recruiting
Southeastern Medical Oncology Center ( Site 0049) Goldsboro North Carolina Recruiting
Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002) Broomall Pennsylvania Recruiting
Cancer Care Associates Of York ( Site 0005) York Pennsylvania Recruiting
Tennessee Oncology-Chattanooga ( Site 0045) Chattanooga Tennessee Recruiting
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0031) Nashville Tennessee Recruiting
Texas Oncology - Central/South Texas ( Site 8008) Austin Texas Recruiting
The Center for Cancer and Blood Disorders ( Site 0032) Fort Worth Texas Recruiting
Texas Oncology - San Antonio ( Site 8006) San Antonio Texas Recruiting
Texas Oncology - Northeast Texas ( Site 8012) Tyler Texas Recruiting

+ 163 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06136559 on ClinicalTrials.gov ↗ ← All trials in the UK