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A Study of Nemtabrutinib for Untreated CLL/SLL

This study is looking at a new medicine called nemtabrutinib for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not had treatment before. Researchers want to see how nemtabrutinib compares to two other common treatments, ibrutinib or acalabrutinib. You might be able to join if you are 18 or older, have a confirmed diagnosis of CLL/SLL that needs treatment, and meet certain health criteria. The main goals are to see if nemtabrutinib can shrink the cancer (Objective Response Rate) and if it can keep the cancer from getting worse for a longer time (Progression-Free Survival). The study plans to enroll about 1200 participants, but its current status is unclear.

Study design
This study compares nemtabrutinib to either ibrutinib or acalabrutinib. It aims to enroll about 1200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure Objective Response Rate for up to about 33 months and Progression-Free Survival for up to about 104 months.

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NCT06136559

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)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~1,200 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:NemtabrutinibIbrutinibAcalabrutinib

At a glance

Recruiting sites
176 of 201 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)
Measured over Up to ~33 months
+1 more outcome measured

Conditions

Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Explore related trials

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Where it's being run

201 sites across 123 states
Turkey (Türkiye)9
Israel7
Japan6
Florida4
Texas4
Taiwan4
Arizona3
California3

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 trial measures

  • Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)Up to ~33 months

    ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR), per iwCLL Criteria 2018 as assessed by BICR.

  • Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by BICRUp to ~104 months

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is evaluated per iwCLL Criteria 2018 as assessed by BICR.