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RECRUITING Phase 3 ClinicalTrials.gov

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).

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT05947851

Registry updated: 2026-10-15
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Description

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).

Interventions

  • Nemtabrutinib (Drug)
    5, 20, and 45 tablets
  • Venetoclax (Drug)
    10, 50, and 100 mg tablets
  • Rituximab (Biological)
    100 mg/10 mL, 500 mg/50 mL (10 mg/mL) IV Infusion

Eligibility criteria

Inclusion Criteria: * 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 * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization * Has a life expectancy of at least 3 months * 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 * Participants with adequate organ function with specimens collected within 7 days before the start of study intervention * If capable of producing sperm, participant agrees to eliminate Nemtabrutinib: 12 days, Venetoclax: 1 month (30 days), Rituximab (rituximab biosimilar): not applicable; abstains from penile-vaginal intercourse as their preferred and usual lifestyle; OR uses prescribed contraception * Participant assigned female sex at birth are eligible to participate if not pregnant or breastfeeding and are not a person of childbearing potential (POCBP) OR is a POCBP and uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, and abstains from breastfeeding Exclusion Criteria: * 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 * Has an active infection requiring systemic therapy, such as intravenous (IV) antibiotics, during screening * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease and/or acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening * Clinically significant cardiovascular disease * Has a known allergy/sensitivity to nemtabrutinib or contraindication to venetoclax/rituximab (or rituximab biosimilar), or any of the excipients * Has history of severe bleeding disorders (eg, hemophilia) * Has received prior systemic anticancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before randomization * Has received prior B-cell lymphoma 2 inhibitor(s) (BCL2i) within ≤ 12 months before randomization or has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids * 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. * Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention * Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration * Has a known psychiatric or substance use disorder that would interfere with the participant's ability to cooperate with the requirements of the study * Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Chronic Lymphocytic Small-Cell Lymphoma Lymphoma, Small Lymphocytic CLL SLL

Locations

  • Highlands Oncology Group ( Site 5405) — Springdale, Arkansas, United States
  • MemorialCare Health System - Long Beach Medical Center ( Site 5421) — Long Beach, California, United States
  • Clermont Oncology Center ( Site 5430) — Clermont, Florida, United States
  • Memorial Hospital West ( Site 5410) — Pembroke Pines, Florida, United States
  • Fort Wayne Medical Oncology and Hematology ( Site 5444) — Fort Wayne, Indiana, United States
  • Center for Cancer and Blood Disorders ( Site 5439) — Bethesda, Maryland, United States
  • Avera Cancer Institute - Marshall ( Site 5462) — Marshall, Minnesota, United States
  • Hattiesburg Clinic Hematology/Oncology ( Site 5416) — Hattiesburg, Mississippi, United States
  • MidAmerica Cancer Care, LLC ( Site 5426) — Kansas City, Missouri, United States
  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 5433) — Billings, Montana, United States
  • Renown Regional Medical Center-Renown Health Medical Oncology ( Site 5434) — Reno, Nevada, United States
  • Atlantic Health System Morristown Medical Center ( Site 5445) — Morristown, New Jersey, United States
  • New York Oncology Hematology, P.C. ( Site 5453) — Albany, New York, United States
  • Oregon Health and Science University ( Site 5425) — Portland, Oregon, United States
  • Avera Cancer Institute - Aberdeen ( Site 5458) — Aberdeen, South Dakota, United States
  • Avera Cancer Institute - Mitchell ( Site 5461) — Mitchell, South Dakota, United States
  • Avera Cancer Institute - Pierre ( Site 5460) — Pierre, South Dakota, United States
  • Avera Cancer Institute- Research ( Site 5437) — Sioux Falls, South Dakota, United States
  • Avera Cancer Institute - Yankton ( Site 5459) — Yankton, South Dakota, United States
  • PatientCare Clinical Research LLC ( Site 5435) — Sugar Land, Texas, United States
  • University of Virginia Cancer Center ( Site 5402) — Charlottesville, Virginia, United States
  • Vista Oncology ( Site 5449) — Olympia, Washington, United States
  • Medical Oncology Associates, PS ( Site 5406) — Spokane, Washington, United States
  • West Virginia University ( Site 5447) — Morgantown, West Virginia, United States
  • University of Wisconsin Hospital and Clinics-Carbone Cancer Center ( Site 5423) — Madison, Wisconsin, United States
  • Instituto Alexander Fleming ( Site 1005) — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 1007) — Mar del Plata, Buenos Aires, Argentina
  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Hematology ( Site 1002) — Buenos Aires, Buenos Aires F.D., Argentina
  • Sanatorio Parque ( Site 1003) — Rosario, Santa Fe Province, Argentina
  • Centro Medico Fleischer ( Site 1006) — Buenos Aires, Argentina
  • Hospital Aleman-oncohematologic diseases ( Site 1001) — Buenos Aires, Argentina
  • Royal Adelaide Hospital ( Site 1104) — Adelaide, South Australia, Australia
  • Box Hill Hospital ( Site 1106) — Box Hill, Victoria, Australia
  • Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 1103) — Melbourne, Victoria, Australia
  • UZ Leuven-Hematology ( Site 1200) — Leuven, Vlaams-Brabant, Belgium
  • ZAS Cadix ( Site 1203) — Antwerp, Belgium
  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 1308) — São Paulo, Brazil
  • Hospital Paulistano-Americas Oncologia ( Site 1302) — São Paulo, Brazil
  • The Moncton Hospital ( Site 1414) — Moncton, New Brunswick, Canada
  • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 1402) — Greenfield Park, Quebec, Canada
  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 1410) — Sherbrooke, Quebec, Canada
  • Biocenter ( Site 1507) — Concepción, Biobio, Chile
  • IC La Serena Research ( Site 1506) — La Serena, Coquimbo Region, Chile
  • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1509) — Santiago, Region M. de Santiago, Chile
  • FALP-UIDO ( Site 1500) — Santiago, Region M. de Santiago, Chile
  • Clínica Inmunocel ( Site 1511) — Santiago, Region M. de Santiago, Chile
  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 1707) — Medellín, Antioquia, Colombia
  • Fundación Valle del Lili ( Site 1703) — Cali, Valle del Cauca Department, Colombia
  • Hopital Claude Huriez - CHU de Lille ( Site 2107) — Lille, Nord, France
  • Centre Hospitalier Universitaire Estaing ( Site 2105) — Clermont-Ferrand, Puy-de-Dome, France
  • CHD Vendee ( Site 2100) — La Roche-sur-Yon, Vendee, France
  • Universitaetsklinikum Ulm. ( Site 2206) — Ulm, Baden-Wurttemberg, Germany
  • Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 2203) — Trier, Rhineland-Palatinate, Germany
  • Universitätsklinikum Leipzig-Medical Department I - Hematology and Celltherapy ( Site 2201) — Leipzig, Saxony, Germany
  • Evangelismos General Hospital of Athens ( Site 2302) — Athens, Attica, Greece
  • General Hospital of Athens "Laiko" ( Site 2308) — Athens, Attica, Greece
  • General Hospital of Athens "Laiko" ( Site 2309) — Athens, Attica, Greece
  • GENERAL HOSPITAL OF ALEXANDROUPOLI ( Site 2310) — Alexandroupoli, East Macedonia and Thrace, Greece
  • Rambam Health Care Campus ( Site 2801) — Haifa, Israel
  • Hadassah Medical Center-Hemato-Oncology ( Site 2812) — Jerusalem, Israel
  • Sheba Medical Center-Hemato Oncology ( Site 2809) — Ramat Gan, Israel
  • Sourasky Medical Center ( Site 2811) — Tel Aviv, Israel
  • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2906) — Alessandria, Italy
  • Ospedale San Raffaele-Programma di Ricerca Strategica sulla LLC ( Site 2902) — Milan, Italy
  • Arcispedale Santa Maria Nuova-Hematology ( Site 2900) — Reggio Emilia, Italy
  • Kochi Medical School Hospital ( Site 3007) — Nankoku, Kochi, Japan
  • Kindai University Hospital ( Site 3005) — Sakai, Osaka, Japan
  • Cancer Institute Hospital of JFCR ( Site 3003) — Koto, Tokyo, Japan
  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 3006) — Hiroshima, Japan
  • Nagasaki University Hospital ( Site 3008) — Nagasaki, Japan
  • National Hospital Organization Osaka National Hospital ( Site 3004) — Osaka, Japan
  • Yamagata University Hospital ( Site 3002) — Yamagata, Japan
  • Centro de Infusion Superare ( Site 3314) — Mexico City, Mexico City, Mexico
  • Health Pharma Professional Research S.A. de C.V: ( Site 3301) — Mexico City, Mexico City, Mexico
  • Centro de Investigacion Clinica Chapultepec ( Site 3309) — Morelia, Michoacán, Mexico
  • Christchurch Hospital ( Site 3503) — Christchurch, Canterbury, New Zealand
  • Palmerston North Hospital ( Site 3506) — Palmerston North, Manawatu-Wanganui, New Zealand
  • North Shore Hospital-Department of Haematology ( Site 3505) — Auckland, New Zealand
  • Aotearoa Clinical Trials ( Site 3504) — Auckland, New Zealand
  • BRCR Global Puerto Rico - Hato Rey ( Site 3901) — San Juan, Puerto Rico
  • Auxilio Mutuo Cancer Center ( Site 3900) — San Juan, Puerto Rico
  • Alberts Cellular Therapy. ( Site 4401) — Pretoria, Gauteng, South Africa
  • Groote Schuur Hospital ( Site 4400) — Cape Town, Western Cape, South Africa
  • Haemalife ( Site 4407) — Kuilsriver, Western Cape, South Africa
  • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4601) — L'Hospitalet Del Llobregat, Barcelona, Spain
  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 4602) — Pozuelo de Alarcón, Madrid, Spain
  • HOSPITAL CLINICO DE VALENCIA-HEMATOLOGY ( Site 4603) — Valencia, Valenciana, Comunitat, Spain
  • Tri-Service General Hospital-hematology&oncology ( Site 4703) — Taipei City, Taipei, Taiwan
  • Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 4700) — Kaohsiung City, Taiwan
  • National Cheng Kung University Hospital ( Site 4701) — Tainan, Taiwan
  • National Taiwan University Hospital ( Site 4704) — Taipei, Taiwan
  • Ege Universitesi Hastanesi ( Site 4902) — Bornova, İzmir, Turkey (Türkiye)
  • Namik Kemal University Medical Faculty-Hematology ( Site 4912) — Tekirdağ, Tekirdas, Turkey (Türkiye)
  • Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 4913) — Ankara, Turkey (Türkiye)
  • Mega Medipol-Hematology ( Site 4904) — Istanbul, Turkey (Türkiye)
  • Sisli Florence Nightingale Hastanesi ( Site 4916) — Istanbul, Turkey (Türkiye)
  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4906) — Istanbul, Turkey (Türkiye)
  • City Hospital, Nottingham University Hospitals-Hematology ( Site 5002) — Nottingham, England, United Kingdom
  • University College London Hospital-Cancer Clinical Trials Unit ( Site 5001) — London-Camden, London, City of, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record