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Looking for participantsPhase3

A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT05947851

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), Venetoclax (drug), Rituximab (biological)
How long the study runs
Study runs about 143 months (dates as stated)
About the drug or intervention
Nemtabrutinib — drug: 5, 20, and 45 tablets · Venetoclax — drug: 10, 50, and 100 mg tablets · Rituximab — biological: 100 mg/10 mL, 500 mg/50 mL (10 mg/mL) IV Infusion
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
735
Started
2023-08-08
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for leukemia, lymphocytic, chronic, b-cell
  • • Phase3 - 735 participants
  • • The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R/R CLL/SLL

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with leukemia, lymphocytic, chronic, b-cell

Where?

  • • Nottingham - City Hospital, Nottingham University Hospitals-Hematology ( Site 5002)
  • • London-Camden - University College London Hospital-Cancer Clinical Trials Unit ( Site 5001)

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

About This Trial

The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R/R CLL/SLL. The primary study hypotheses are that the combination of nemtabrutinib plus venetoclax is superior to VR with respect to progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria as assessed by blinded independent central review (BICR).

Leukemia, Lymphocytic, Chronic, B-CellLeukemia, Chronic LymphocyticSmall-Cell LymphomaLymphoma, Small LymphocyticCLLSLL

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

Biomarkers mentioned

TP53has a negative

Treatment history

Treatments you must have had:

  • ✓ before randomization for Part 2 participants only

What the study is looking for

  • ✓Confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and active disease clearly...
  • ✓Deletion (Del) (17p) status, tumor protein 53 (TP53) mutation status, and immunoglobulin heavy chain gene (IGHV)...
  • ✓Relapsed or refractory to at least 1 prior available therapy
  • ✓Have at least 1 marker of disease burden
  • ✓Has an activity scale (ECOG) performance status of 0 to 2 within 7 days before randomization

Who cannot take part

  • ✗Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection
  • ✗Has gastrointestinal (GI) dysfunction that may affect drug absorption
  • ✗Has a known additional cancer that is progressing or has required active treatment within the past 2 years
  • ✗Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL
  • ✗Has an active infection requiring treatment that goes through your whole body, such as intravenous (IV) antibiotics, during screening
See the full criteria
Inclusion Criteria: * Confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and active disease clearly documented to initiate therapy * Deletion (Del) (17p) status, tumor protein 53 (TP53) mutation status, and immunoglobulin heavy chain gene (IGHV) mutation status results required before randomization for Part 2 participants only * Relapsed or refractory to at least 1 prior available therapy * Have 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 a life expectancy of at least 3 months * 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 * Participants with adequate organ function with specimens collected within 7 days before the start of study intervention * If capable of producing sperm, participant agrees to eliminate Nemtabrutinib: 12 days, Venetoclax: 1 month (30 days), Rituximab (rituximab biosimilar): not applicable; abstains from penile-vaginal intercourse as their preferred and usual lifestyle; OR uses prescribed contraception * Participant assigned female sex at birth are eligible to participate if not pregnant or breastfeeding and are not a person of childbearing potential (POCBP) OR is a POCBP and uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, and abstains from breastfeeding Exclusion Criteria: * Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection * Has gastrointestinal (GI) dysfunction that may affect drug absorption * Has a known additional malignancy that is progressing or has required active treatment within the past 2 years * Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL * Has an active infection requiring systemic therapy, such as intravenous (IV) antibiotics, during screening * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease and/or acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening * Clinically significant cardiovascular disease * Has a known allergy/sensitivity to nemtabrutinib or contraindication to venetoclax/rituximab (or rituximab biosimilar), or any of the excipients * Has history of severe bleeding disorders (eg, hemophilia) * Has received prior systemic anticancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before randomization * Has received prior B-cell lymphoma 2 inhibitor(s) (BCL2i) within ≤ 12 months before randomization or has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids * 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. * Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention * Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration * Has a known psychiatric or substance use disorder that would interfere with the participant's ability to cooperate with the requirements of the study * Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Where Is This Study? (2 UK sites)

City Hospital, Nottingham University Hospitals-Hematology ( Site 5002)

Nottingham NG5 1PF, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+44115969116972549

University College London Hospital-Cancer Clinical Trials Unit ( Site 5001)

London-Camden NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4420 3447 2528

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: 2026-10