Trials / Recruiting
RecruitingNCT06136559
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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,200 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nemtabrutinib | Administered orally |
| DRUG | Ibrutinib | Administered orally |
| DRUG | Acalabrutinib | Administered orally |
Timeline
- Start date
- 2023-12-13
- Primary completion
- 2032-09-07
- Completion
- 2032-09-07
- First posted
- 2023-11-18
- Last updated
- 2026-04-13
Locations
196 sites across 29 countries: United States, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Germany, Greece, Hong Kong, Israel, Japan, Malaysia, Mexico, New Zealand, Norway, Peru, Poland, Portugal, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06136559. Inclusion in this directory is not an endorsement.