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Chronic Lymphocytic LeukemiaCancerDrugPhase 3

What this study is

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.

What's being tested

  • Nemtabrutinib

    Intervention · DRUG

  • Ibrutinib

    Intervention · DRUG

  • Acalabrutinib

    Intervention · DRUG

All interventions

Administered orally

Study details

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)
Sponsor
Merck Sharp & Dohme LLC
Conditions
Chronic Lymphocytic Leukemia · Small Lymphocytic Lymphoma
Enrolling
1,200 people
Starts
2023-12-13
Est. completion
2032-09-07
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗