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).

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Nemtabrutinib
  • Venetoclax
  • Rituximab

Treatment groups

735 Participants
are divided into 2 treatment groups

Sponsors and collaborators