Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase3

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)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06136559

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Nemtabrutinib (drug), Ibrutinib (drug), Acalabrutinib (drug)
How long the study runs
Study runs about 105 months (dates as stated)
About the drug or intervention
Nemtabrutinib — drug: Administered orally · Ibrutinib — drug: Administered orally · Acalabrutinib — drug: Administered orally
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,200
Started
2023-12-13
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic lymphocytic leukemia
  • • Phase3 - 1,200 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with chronic lymphocytic leukemia

Where?

  • • Bristol - Southmead Hospital ( Site 3010)
  • • Lancaster - Royal Lancaster Infirmary ( Site 3012)
  • • London - St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006)
  • • Oxford - The Churchill Hospital ( Site 3007)
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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 activity scale (ECOG) performance status of 0 to 2 within 7 days before randomization.
  • ✓Has the ability to swallow and retain oral medication.

Who cannot take part

  • ✗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...
See the full 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.

Where Is This Study? (10 UK sites)

Southmead Hospital ( Site 3010)

Bristol BS10 5NB, United Kingdom

COMPLETED

Royal Lancaster Infirmary ( Site 3012)

Lancaster LA1 4RP, United Kingdom

COMPLETED

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442073777000

The Churchill Hospital ( Site 3007)

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator441865235886

GenesisCare - Bristol ( Site 3011)

Bristol BS32 4SY, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441173421121

GenesisCare - Cambridge ( Site 3001)

Newmarket CB8 7XN, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01223 907622

GenesisCare - Windsor ( Site 3002)

Windsor SL4 3HD, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator447989474250

Barnet Hospital ( Site 3005)

Barnet EN5 3DJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0208 216 4755

St James's University Hospital ( Site 3004)

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441132432799

City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003)

Nottingham NG5 1PB, United Kingdom

COMPLETED
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09