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 now · Phase 3

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

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.

Key facts

Study ID

NCT06136559

Run by

Merck Sharp & Dohme LLC

People needed

1200

Starts

2023-12-13

Expected to finish

2032-09-07

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Has known additional malignancy that is progressing or has required active treatment within the past 2 years.
• Has received any systemic anticancer therapy for CLL/SLL.
• Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.
• Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
• Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.
• Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening.
• Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Where it is running

• John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016) — Hackensack, New Jersey, United States (enrolling)
• Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051) — Phoenix, Arizona, United States (enrolling)
• Banner MD Anderson Cancer Center ( Site 0059) — Gilbert, Arizona, United States (enrolling)
• USA Mitchell Cancer Institute ( Site 0014) — Mobile, Alabama, United States (enrolling)
• Moores Cancer Center ( Site 0003) — La Jolla, California, United States (enrolling)
• Care Access - South Pasadena ( Site 0070) — Pasadena, California, United States (enrolling)
• Saint Joseph Hospital ( Site 0026) — Denver, Colorado, United States (enrolling)
• Lutheran Medical Center ( Site 0027) — Golden, Colorado, United States (enrolling)
• Intermountain Health St. Mary's Regional Hospital ( Site 0025) — Grand Junction, Colorado, United States (enrolling)
• Eastern CT Hematology & Oncology Associates ( Site 0033) — Norwich, Connecticut, United States (enrolling)
• Lynn Cancer Center at Boca Raton Regional Hospital ( Site 0063) — Boca Raton, Florida, United States (enrolling)
• Clermont Oncology Center ( Site 0046) — Clermont, Florida, United States (enrolling)
• Florida Cancer Specialists - South ( Site 7001) — Fort Myers, Florida, United States (enrolling)
• Florida Cancer Specialists - East ( Site 7002) — West Palm Beach, Florida, United States (enrolling)
• Saint Alphonsus Regional Medical Center ( Site 0067) — Boise, Idaho, United States (enrolling)
• Parkview Research Center at Parkview Regional Medical Center ( Site 0002) — Fort Wayne, Indiana, United States (enrolling)
• University of Iowa Health Care. ( Site 0017) — Iowa City, Iowa, United States (enrolling)
• University of Iowa Health Care. ( Site 0057) — Waukee, Iowa, United States (enrolling)
• Saint Elizabeth Healthcare ( Site 0041) — Edgewood, Kentucky, United States (enrolling)
• Owensboro Medical Health System ( Site 0066) — Owensboro, Kentucky, United States (enrolling)
• Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011) — Grand Rapids, Michigan, United States (enrolling)
• Regions Hospital ( Site 0042) — Saint Louis Park, Minnesota, United States (enrolling)
• MidAmerica Cancer Care, LLC ( Site 0043) — Kansas City, Missouri, United States (enrolling)
• Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052) — Billings, Montana, United States (enrolling)
• New York Oncology Hematology, P.C. ( Site 0069) — Albany, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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