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)

NCT06136559
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,200
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2023-12-13
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Number of sites
201
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Summary
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.
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Short title
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)
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Official title
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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2032-09-07
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First posted
2023-11-18
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Registry last updated
2026-08-27
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Primary completion date
2032-09-07
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Start date
2023-12-13
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Participants
1,200
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Participant count basis
Estimated
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Planned participants
1,200
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Protocol amendments
3
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Number of sites
201
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Merck Sharp & Dohme LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06136559
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ClinicalTrials.gov ID
NCT06136559
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)

    Timeframe: Up to ~33 months

    ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR), per iwCLL Criteria 2018 as assessed by BICR.

  2. Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by BICR

    Timeframe: Up to ~104 months

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is evaluated per iwCLL Criteria 2018 as assessed by BICR.

  1. Overall Survival (OS)

    Timeframe: Up to ~104 months

    OS is defined as the time from randomization to death due to any cause.

  2. Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR

    Timeframe: Up to ~104 months

    For participants who demonstrate a complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR) per iwCLL Criteria 2018 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR, CRi, nPR, or PR that led to response until disease progression or death due to any cause, whichever occurs first.

  3. Number of Participants Who Experience One or More Adverse Events (AEs)

    Timeframe: Up to ~104 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  4. Number of Participants Who Discontinue Study Treatment Due to an AE

    Timeframe: Up to ~104 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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.

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.
Sources for eligibility
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  • USA Mitchell Cancer Institute ( Site 0014)Mobile, United StatesRecruiting
  • Banner MD Anderson Cancer Center ( Site 0059)Gilbert, United StatesRecruiting
  • Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)Phoenix, United StatesRecruiting
  • Arizona Oncology Associates - NAHOA ( Site 8007)Prescott, United StatesCompleted
  • Alta Bates Summit Medical Center ( Site 0004)Berkeley, United StatesActive, not recruiting
  • Moores Cancer Center ( Site 0003)La Jolla, United StatesRecruiting
  • Care Access - South Pasadena ( Site 0070)Pasadena, United StatesRecruiting
  • Saint Joseph Hospital ( Site 0026)Denver, United StatesRecruiting
  • Lutheran Medical Center ( Site 0027)Golden, United StatesRecruiting
  • Intermountain Health St. Mary's Regional Hospital ( Site 0025)Grand Junction, United StatesRecruiting
  • Eastern CT Hematology & Oncology Associates ( Site 0033)Norwich, United StatesRecruiting
  • Lynn Cancer Center at Boca Raton Regional Hospital ( Site 0063)Boca Raton, United StatesRecruiting
  • Clermont Oncology Center ( Site 0046)Clermont, United StatesRecruiting
  • Florida Cancer Specialists - South ( Site 7001)Fort Myers, United StatesRecruiting
  • Florida Cancer Specialists - East ( Site 7002)West Palm Beach, United StatesRecruiting
  • Saint Alphonsus Regional Medical Center ( Site 0067)Boise, United StatesRecruiting
  • Parkview Research Center at Parkview Regional Medical Center ( Site 0002)Fort Wayne, United StatesRecruiting
  • University of Iowa Health Care. ( Site 0017)Iowa City, United StatesRecruiting
  • University of Iowa Health Care. ( Site 0057)Waukee, United StatesRecruiting
  • Saint Elizabeth Healthcare ( Site 0041)Edgewood, United StatesRecruiting
  • Owensboro Medical Health System ( Site 0066)Owensboro, United StatesRecruiting
  • Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)Grand Rapids, United StatesRecruiting
  • Regions Hospital ( Site 0042)Saint Louis Park, United StatesRecruiting
  • MidAmerica Cancer Care, LLC ( Site 0043)Kansas City, United StatesRecruiting
  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052)Billings, United StatesRecruiting

And 176 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • MK-1026-011
  • U1111-1281-7895
  • jRCT2031230697
  • 2022-501697-19-00
Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (1)