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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).

StatusRecruiting
PhasePhase 3
Started2023-08-08
View on ClinicalTrials.gov ↗

Amendment history

The 49 most recent of 80 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-22
Trial sites expanded: 67 → 70 locations
2026-09-10
Study Status, Contacts/Locations v79
Trial sites expanded: 70 → 79 locations
2026-08-25
Study Status, Contacts/Locations v78
Study sites64→65
2026-08-20
Study Status, Contacts/Locations v77
Trial sites expanded: 52 → 64 locations
2026-08-13
Study Status, Contacts/Locations v76
Trial sites reduced: 59 → 52 locations
2026-08-06
Study Status, Contacts/Locations v75
Trial sites expanded: 55 → 59 locations
2026-07-23
Study Identification, Study Status v74
Re-verified, no change to tracked fields
2026-07-21
Study Status, Arms and Interventions, Contacts/Locations v73
Study sites54→55
2026-05-14
Study Status, Contacts/Locations v72
Study sitesdetails revised at 2 of 54 sites
2026-05-07
Study Status, Contacts/Locations v71
Study sites52→54
2026-03-11
Study Status, Contacts/Locations v70
Study sitesdetails revised at 1 of 52 sites
2026-02-20
Study Status, Contacts/Locations v69
Study sitesdetails revised at 1 of 52 sites
2026-02-10
Study Status, Contacts/Locations v68
Study sitesdetails revised at 7 of 52 sites
2026-01-29
Study Status, Contacts/Locations v67
Study sitesdetails revised at 1 of 52 sites
2025-12-23
Study Status, Contacts/Locations v66
Study sites52 entries, revised
Netcare Pretoria East Hospital-Albert Alberts StemCellular Cell Transplant CentreTherapy. ( Site 4401)
2025-11-12
Study Status, Contacts/Locations v65
Study sitescontacts updated at 2 of 52 sites
2025-11-10
Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v64
Primary completion date2035-03-14→2032-06-01
Completion date2035-03-14→2035-07-01
Enrollment target720→735
Eligibility criteria-36 characters
[...] L) 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 and Bruton's tyrosine kinase (BTK)-C481 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 swal [...] [...]
Secondary endpoints6 entries, revised
Part 2: Undetectable minimalMinimal residualResidual diseaseDisease (MRD) rateRate in boneBone marrowMarrow as assessedAssessed by centralCentral laboratoryLaboratory Part 2: Objective Response Rate (ORR) per iwCLL Criteria 2018 as assessedAssessed by BICR Part 2: Duration of Response (DOR) per iwCLL Criteria 2018 as assessedAssessed by BICR Part 2: Number of participantsParticipants experiencingExperiencing AEs Part 2: Number of participantsParticipants discontinuingDiscontinuing studyStudy treatmentTreatment dueDue to AEs
Primary endpoints4 entries, revised
Part 1: Number of participantsParticipants discontinuingDiscontinuing studyStudy treatmentTreatment dueDue to AEs Part 1: Number of participantsParticipants experiencingExperiencing adverseAdverse eventsEvents (AEs) Part 1: Number of participantsParticipants experiencingExperiencing doseDose-limitingLimiting toxicitiesToxicities (DLTs) Part 2: PFS per the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as assessedAssessed by Blinded Independent Central Review (BICR)
Study sitescontacts updated at 1 of 52 sites
2025-10-23
Study Status, Contacts/Locations v63
Study sitesdetails revised at 5 of 52 sites
2025-09-17
Study Status, Contacts/Locations v62
Study sitescontacts updated at 1 of 52 sites
2025-09-09
Study Status, Contacts/Locations v61
Study sitescontacts updated at 3 of 52 sites
2025-07-14
Study Status, Contacts/Locations v60
Primary completion date2033-06-27→2035-03-14
Completion date2033-06-27→2035-03-14
Study sitescontacts updated at 8 of 52 sites
2025-06-27
Study Status, Contacts/Locations v59
Study sites55→52
2025-06-11
Study Status, Contacts/Locations v58
Study sitescontacts updated at 1 of 55 sites
2025-06-06
Study Status, Contacts/Locations v57
Study sitesdetails revised at 3 of 55 sites
2025-05-30
Study Status, Contacts/Locations v56
Study sitescontacts updated at 1 of 55 sites
2025-05-23
Study Status, Contacts/Locations v55
Study sitescontacts updated at 2 of 55 sites
2025-05-13
Study Status, Contacts/Locations v54
Study sites54→55
2025-05-02
Study Identification, Study Status, Contacts/Locations v53
Study sitesdetails revised at 4 of 54 sites
2025-04-24
Study Status, Contacts/Locations v52
Study sitesdetails revised at 1 of 54 sites
2025-04-17
Study Status, Contacts/Locations v51
Study sites54 entries, revised
Azienda Ospedaliera NazionaleOspedaliero-Universitaria SS. Antonio e Biagio e Cesare -AziendaArrigo Ospedaliera( NazionaleSite SS. Ant2906)
2025-04-02
Study Status, Contacts/Locations v50
Study sitescontacts updated at 1 of 54 sites
2025-03-26
Study Status, Contacts/Locations v49
Study sitescontacts updated at 4 of 54 sites
2025-03-20
Study Status, Contacts/Locations v48
Study sitescontacts updated at 2 of 54 sites
2025-03-13
Study Status, Contacts/Locations v47
Study sitesdetails revised at 1 of 54 sites
2025-03-06
Study Status, Contacts/Locations v46
Study sites52→54
2025-02-26
Study Identification, Study Status, Contacts/Locations, IPDSharing v45
Study sitesdetails revised at 2 of 52 sites
2025-02-07
Study Status, Contacts/Locations v44
Study sites51→52
2025-01-07
Study Status, Contacts/Locations v43
Study sites50→51
2024-12-26
Study Status, Contacts/Locations v42
Study sites49→50
2024-12-17
Study Identification, Study Status v41
Study title+1 characters
[...] ll Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
2024-12-04
Study Status, Contacts/Locations v40
Study sites48→49
2024-11-22
Study Status, Contacts/Locations, References v39
Study sites47→48
2024-10-24
Study Status, Contacts/Locations v38
Study sitescontacts updated at 1 of 47 sites
2024-10-17
Study Status, Contacts/Locations v37
Study sites46→47
2024-10-09
Study Status v36
Re-verified, no change to tracked fields
2024-09-25
Study Status, Contacts/Locations v35
Study sites45→46
2024-09-19
Study Status, Contacts/Locations v34
Study sitesdetails revised at 1 of 45 sites
2024-09-10
Study Identification, Study Status, Contacts/Locations v33
Study sitesdetails revised at 1 of 45 sites
2024-07-18
Study Status, Contacts/Locations v32
Study sites44→45
2024-06-26
Study Status, Contacts/Locations v31
Study sitesdetails revised at 3 of 44 sites
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).
Trial Details
NCT Number NCT05947851
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic, Small-Cell Lymphoma, Lymphoma, Small Lymphocytic, CLL, SLL
Enrollment 735 participants
Start Date 2023-08-08
Primary Completion 2032-06-01 (estimated)
Study Completion 2035-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-24