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Clinical Trials List

Protocol NumberMK-1026-010
NCT Number(ClinicalTrials.gov Identfier)NCT05947851
Not yet recruiting

2026-04-01 - 2037-12-31

Phase III

Recruiting4

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)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/10

Investigators and Locations

Principal Investigator Shang-Ju Wu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳佳宏 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王銘崇 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Sin-Syue Li
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Leukemia, Lymphocytic, Chronic, B-Cell

Objectives

•評估 nemtabrutinib 併用venetoclax 的安全性和耐受性並確定其劑量。 •由盲性獨立中央審查（BICR）根據 2018 年國際慢性淋巴性白血病工作小組（iwCLL）標準進行評估，比較nemtabrutinib + venetoclax 與 venetoclax 加上rituximab（VR）的無惡化存活期（PFS）。

Test Drug

錠劑

Active Ingredient

Nemtabrutinib (MK-1026; previously known as ARQ 531)

Dosage Form

110

Dosage

5 mg; 20 mg; 45mg

Endpoints

•劑量限制毒性（DLT）
•不良事件（AE）
•因 AE 造成的試驗治療停止
•PFS，定義為從隨機分配至首次記錄疾病惡化或因任何原因死亡的時間，以先發生者為準

Inclution 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

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

The Estimated Number of Participants

  • Taiwan

    25 participants

  • Global

    735 participants

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