Clinical Trial

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).

Recruiting Phase 3
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Summary
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).
Protocol Amendment History 1 change
notable Trial sites expanded: 55 -> 59 locations 2026-08-08
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 2026-08-07