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RECRUITING

NCT05947851

PHASE3

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

View on ClinicalTrials.gov

Summary

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).

Official title: A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib (MK-1026) Plus Venetoclax Versus Venetoclax Plus Rituximab in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Following at Least 1 Prior Therapy (BELLWAVE-010)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

735

Start Date

2023-08-08

Completion Date

2035-07-01

Last Updated

2026-03-13

Healthy Volunteers

Conditions

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

Interventions

DRUG

Nemtabrutinib

5, 20, 45, and 65 mg tablets

DRUG

Venetoclax

10, 50, and 100 mg tablets

BIOLOGICAL

Rituximab

100 mg/10 mL, 500 mg/50 mL (10 mg/mL) IV Infusion

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

Locations (52)

Highlands Oncology Group ( Site 5405)

Springdale, Arkansas, United States

MemorialCare Health System - Long Beach Medical Center ( Site 5421)

Long Beach, California, United States

Memorial Hospital West ( Site 5410)

Pembroke Pines, Florida, United States

Oregon Health and Science University ( Site 5425)

Portland, Oregon, United States

Medical Oncology Associates, PS ( Site 5406)

Spokane, Washington, 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

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

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

The Moncton Hospital ( Site 1414)

Moncton, New Brunswick, Canada

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

Biocenter ( Site 1507)

Concepción, Región del Biobío, Chile

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

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

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

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

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

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)

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

Clinical Research Directory

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).

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (52)