Clinical Trial

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 Phase 3
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Summary
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.
Protocol Amendment History 104 amendments
This ClinicalTrials.gov record has been amended 104 times since 2023-11-13; most recent amendment 2026-07-16.
Status change: Not Yet Recruiting → Recruiting 2023-12-19
Trial Details
NCT Number NCT06136559
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 1,200 participants
Start Date 2023-12-13
Primary Completion 2032-09-07 (estimated)
Study Completion 2032-09-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-07