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)

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 prog

Trial Details

NCT ID
NCT06136559
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Nemtabrutinib
  • Ibrutinib
  • Acalabrutinib
Locations (sample)
  • Mobile, Alabama, United States|30.69436,-88.04305
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Berkeley, California, United States|37.87159,-122.27275
  • Denver, Colorado, United States|39.73915,-104.9847
  • Norwich, Connecticut, United States|41.52426,-72.07591

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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