RecruitingChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

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)

Eligible age

18+ yrs

Accepts

All genders

Locations

23 states

Healthy volunteers

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About this study

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.

Sponsor: Merck Sharp & Dohme LLC

You may qualify if…

✓ The main inclusion criteria include but are not limited to the following:
✓ Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.
✓ Has 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 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.

You may not qualify if…

✕ The main exclusion criteria include but are not limited to the following:
✕ Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
✕ Has gastrointestinal (GI) dysfunction that may affect drug absorption.
✕ Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
✕ Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.
✕ Has clinically significant cardiovascular disease.
✕ Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.
✕ Has history of severe bleeding disorder.