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RecruitingPhase 3

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)

A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares nemtabrutinib with either ibrutinib or acalabrutinib, chosen by the study doctor. It is for people with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), two blood cancers, who need treatment. Researchers will test how well the drugs control the cancer and how long they keep it from getting worse.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed CLL or SLL that is active and needs treatment.
  • Have at least one sign that shows how much cancer is present.
  • Be able to care for yourself and be out of bed or a chair for at least half the day, checked within 7 days before study group assignment.
  • Be able to swallow medicine and keep it down.
  • If you test positive for hepatitis B surface antigen, have at least 4 weeks of antiviral treatment and no detectable hepatitis B virus before study group assignment.
  • If you have had hepatitis C, have no detectable hepatitis C virus at screening.
  • If you have HIV, meet all study eligibility rules.

Who can't join

  • Have active hepatitis B or C, an infection needing treatment throughout the body, or an AIDS-related infection within the past 12 months.
  • Have gut problems that may affect how medicine enters your body, serious heart or blood vessel disease, or a history of a severe bleeding disorder.
  • Have Richter transformation, when CLL/SLL becomes a faster-growing cancer; CLL/SLL in the brain or spinal cord; or another cancer that is growing or needed treatment within the past 2 years.
  • Have had CLL/SLL cancer treatment that travels throughout the body, or take certain medicines that can affect study drug levels or safety.
  • Are allergic to nemtabrutinib or its ingredients, or cannot safely take ibrutinib or acalabrutinib.
  • Had radiation within 2 weeks before study treatment, or have radiation side effects needing steroid medicine.
  • Had a live vaccine within 30 days before the first study dose, or used an experimental drug or device within 4 weeks before study treatment.
  • Have not healed enough after major surgery or still have problems from surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Study sites (49)

AL

AZ

CA

CO

CT

FL

IA

ID

IN

KY

MI

MN

MO

MT

  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052) · Billings, MT 59102Study Coordinator · Study contact · 406-238-6685More trials in Billings

NC

NJ

NY

PA

TN

TX

VA

WA

WI