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)

Description

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.

Conditions

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Study Overview

Study Details

Study overview

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.

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)

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)

Condition
Chronic Lymphocytic Leukemia
Intervention / Treatment

-

Contacts and Locations

Mobile

USA Mitchell Cancer Institute ( Site 0014), Mobile, Alabama, United States, 36604

Berkeley

Alta Bates Summit Medical Center ( Site 0004), Berkeley, California, United States, 94704

La Jolla

Moores Cancer Center ( Site 0003), La Jolla, California, United States, 92093-0698

Fort Wayne

Parkview Research Center at Parkview Regional Medical Center ( Site 0002), Fort Wayne, Indiana, United States, 46845

Iowa City

University of Iowa-Holden Comprehensive Cancer Center ( Site 0017), Iowa City, Iowa, United States, 52242

Grand Rapids

Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011), Grand Rapids, Michigan, United States, 49503

Florham Park

Summit Medical Group Cancer Center ( Site 0007), Florham Park, New Jersey, United States, 07932

Hackensack

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016), Hackensack, New Jersey, United States, 07601

York

Cancer Care Associates Of York ( Site 0005), York, Pennsylvania, United States, 17403

Fairfax

Inova Schar Cancer Institute ( Site 0015), Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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 history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 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.
  • * Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2032-09-30